different types of studies in research

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In brief: what types of studies are there.

Last Update: March 25, 2020 ; Next update: 2024.

There are various types of scientific studies such as experiments and comparative analyses, observational studies, surveys, or interviews. The choice of study type will mainly depend on the research question being asked.

When making decisions, patients and doctors need reliable answers to a number of questions. Depending on the medical condition and patient's personal situation, the following questions may be asked:

• What is the cause of the condition?
• What is the natural course of the disease if left untreated?
• What will change because of the treatment?
• How many other people have the same condition?
• How do other people cope with it?

Each of these questions can best be answered by a different type of study.

In order to get reliable results, a study has to be carefully planned right from the start. One thing that is especially important to consider is which type of study is best suited to the research question. A study protocol should be written and complete documentation of the study's process should also be done. This is vital in order for other scientists to be able to reproduce and check the results afterwards.

The main types of studies are randomized controlled trials (RCTs), cohort studies, case-control studies and qualitative studies.

• Randomized controlled trials

If you want to know how effective a treatment or diagnostic test is, randomized trials provide the most reliable answers. Because the effect of the treatment is often compared with "no treatment" (or a different treatment), they can also show what happens if you opt to not have the treatment or diagnostic test.

When planning this type of study, a research question is stipulated first. This involves deciding what exactly should be tested and in what group of people. In order to be able to reliably assess how effective the treatment is, the following things also need to be determined before the study is started:

• How long the study should last
• How many participants are needed
• How the effect of the treatment should be measured

For instance, a medication used to treat menopause symptoms needs to be tested on a different group of people than a flu medicine. And a study on treatment for a stuffy nose may be much shorter than a study on a drug taken to prevent strokes .

“Randomized” means divided into groups by chance. In RCTs participants are randomly assigned to one of two or more groups. Then one group receives the new drug A, for example, while the other group receives the conventional drug B or a placebo (dummy drug). Things like the appearance and taste of the drug and the placebo should be as similar as possible. Ideally, the assignment to the various groups is done "double blinded," meaning that neither the participants nor their doctors know who is in which group.

The assignment to groups has to be random in order to make sure that only the effects of the medications are compared, and no other factors influence the results. If doctors decided themselves which patients should receive which treatment, they might – for instance – give the more promising drug to patients who have better chances of recovery. This would distort the results. Random allocation ensures that differences between the results of the two groups at the end of the study are actually due to the treatment and not something else.

Randomized controlled trials provide the best results when trying to find out if there is a causal relationship. That means finding out whether a certain effect is actually due to the medication being tested. RCTs can answer questions such as these:

• Is the new drug A better than the standard treatment for medical condition X?
• Does regular physical activity speed up recovery after a slipped disc when compared to passive waiting?
• Cohort studies

A cohort is a group of people who are observed frequently over a period of many years – for instance, to determine how often a certain disease occurs. In a cohort study, two (or more) groups that are exposed to different things are compared with each other: For example, one group might smoke while the other doesn't. Or one group may be exposed to a hazardous substance at work, while the comparison group isn't. The researchers then observe how the health of the people in both groups develops over the course of several years, whether they become ill, and how many of them pass away. Cohort studies often include people who are healthy at the start of the study. Cohort studies can have a prospective (forward-looking) design or a retrospective (backward-looking) design. In a prospective study, the result that the researchers are interested in (such as a specific illness) has not yet occurred by the time the study starts. But the outcomes that they want to measure and other possible influential factors can be precisely defined beforehand. In a retrospective study, the result (the illness) has already occurred before the study starts, and the researchers look at the patient's history to find risk factors.

Cohort studies are especially useful if you want to find out how common a medical condition is and which factors increase the risk of developing it. They can answer questions such as:

• How does high blood pressure affect heart health?
• Does smoking increase your risk of lung cancer?

For example, one famous long-term cohort study observed a group of 40,000 British doctors, many of whom smoked. It tracked how many doctors died over the years, and what they died of. The study showed that smoking caused a lot of deaths, and that people who smoked more were more likely to get ill and die.

• Case-control studies

Case-control studies compare people who have a certain medical condition with people who do not have the medical condition, but who are otherwise as similar as possible, for example in terms of their sex and age. Then the two groups are interviewed, or their medical files are analyzed, to find anything that might be risk factors for the disease. So case-control studies are generally retrospective.

Case-control studies are one way to gain knowledge about rare diseases. They are also not as expensive or time-consuming as RCTs or cohort studies. But it is often difficult to tell which people are the most similar to each other and should therefore be compared with each other. Because the researchers usually ask about past events, they are dependent on the participants’ memories. But the people they interview might no longer remember whether they were, for instance, exposed to certain risk factors in the past.

Still, case-control studies can help to investigate the causes of a specific disease, and answer questions like these:

• Do HPV infections increase the risk of cervical cancer ?
• Is the risk of sudden infant death syndrome (“cot death”) increased by parents smoking at home?

Cohort studies and case-control studies are types of "observational studies."

• Cross-sectional studies

Many people will be familiar with this kind of study. The classic type of cross-sectional study is the survey: A representative group of people – usually a random sample – are interviewed or examined in order to find out their opinions or facts. Because this data is collected only once, cross-sectional studies are relatively quick and inexpensive. They can provide information on things like the prevalence of a particular disease (how common it is). But they can't tell us anything about the cause of a disease or what the best treatment might be.

Cross-sectional studies can answer questions such as these:

• How tall are German men and women at age 20?
• How many people have cancer screening?
• Qualitative studies

This type of study helps us understand, for instance, what it is like for people to live with a certain disease. Unlike other kinds of research, qualitative research does not rely on numbers and data. Instead, it is based on information collected by talking to people who have a particular medical condition and people close to them. Written documents and observations are used too. The information that is obtained is then analyzed and interpreted using a number of methods.

Qualitative studies can answer questions such as these:

• How do women experience a Cesarean section?
• What aspects of treatment are especially important to men who have prostate cancer ?
• How reliable are the different types of studies?

Each type of study has its advantages and disadvantages. It is always important to find out the following: Did the researchers select a study type that will actually allow them to find the answers they are looking for? You can’t use a survey to find out what is causing a particular disease, for instance.

It is really only possible to draw reliable conclusions about cause and effect by using randomized controlled trials. Other types of studies usually only allow us to establish correlations (relationships where it isn’t clear whether one thing is causing the other). For instance, data from a cohort study may show that people who eat more red meat develop bowel cancer more often than people who don't. This might suggest that eating red meat can increase your risk of getting bowel cancer. But people who eat a lot of red meat might also smoke more, drink more alcohol , or tend to be overweight . The influence of these and other possible risk factors can only be determined by comparing two equal-sized groups made up of randomly assigned participants.

That is why randomized controlled trials are usually the only suitable way to find out how effective a treatment is. Systematic reviews, which summarize multiple RCTs , are even better. In order to be good-quality, though, all studies and systematic reviews need to be designed properly and eliminate as many potential sources of error as possible.

• Greenhalgh T. Einführung in die Evidence-based Medicine: kritische Beurteilung klinischer Studien als Basis einer rationalen Medizin. Bern: Huber; 2003.
• Institute for Quality and Efficiency in Health Care (IQWiG, Germany). General methods . Version 5.0. Cologne: IQWiG; 2017.
• Klug SJ, Bender R, Blettner M, Lange S. Wichtige epidemiologische Studientypen . Dtsch Med Wochenschr 2004; 129: T7-T10. [ PubMed : 17530597 ]
• Schäfer T. Kritische Bewertung von Studien zur Ätiologie. In: Kunz R, Ollenschläger G, Raspe H, Jonitz G, Donner-Banzhoff N (Ed). Lehrbuch evidenzbasierte Medizin in Klinik und Praxis. Cologne: Deutscher Ärzte-Verlag; 2007.

IQWiG health information is written with the aim of helping people understand the advantages and disadvantages of the main treatment options and health care services.

Because IQWiG is a German institute, some of the information provided here is specific to the German health care system. The suitability of any of the described options in an individual case can be determined by talking to a doctor. informedhealth.org can provide support for talks with doctors and other medical professionals, but cannot replace them. We do not offer individual consultations.

Our information is based on the results of good-quality studies. It is written by a team of health care professionals, scientists and editors, and reviewed by external experts. You can find a detailed description of how our health information is produced and updated in our methods.

• Cite this Page InformedHealth.org [Internet]. Cologne, Germany: Institute for Quality and Efficiency in Health Care (IQWiG); 2006-. In brief: What types of studies are there? [Updated 2020 Mar 25].

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An introduction to different types of study design

Posted on 6th April 2021 by Hadi Abbas

Study designs are the set of methods and procedures used to collect and analyze data in a study.

Broadly speaking, there are 2 types of study designs: descriptive studies and analytical studies.

Descriptive studies

• Describes specific characteristics in a population of interest
• The most common forms are case reports and case series
• In a case report, we discuss our experience with the patient’s symptoms, signs, diagnosis, and treatment
• In a case series, several patients with similar experiences are grouped.

Analytical Studies

Analytical studies are of 2 types: observational and experimental.

Observational studies are studies that we conduct without any intervention or experiment. In those studies, we purely observe the outcomes.  On the other hand, in experimental studies, we conduct experiments and interventions.

Observational studies

Observational studies include many subtypes. Below, I will discuss the most common designs.

Cross-sectional study:

• This design is transverse where we take a specific sample at a specific time without any follow-up
• It allows us to calculate the frequency of disease ( p revalence ) or the frequency of a risk factor
• This design is easy to conduct
• For example – if we want to know the prevalence of migraine in a population, we can conduct a cross-sectional study whereby we take a sample from the population and calculate the number of patients with migraine headaches.

Cohort study:

• We conduct this study by comparing two samples from the population: one sample with a risk factor while the other lacks this risk factor
• It shows us the risk of developing the disease in individuals with the risk factor compared to those without the risk factor ( RR = relative risk )
• Prospective : we follow the individuals in the future to know who will develop the disease
• Retrospective : we look to the past to know who developed the disease (e.g. using medical records)
• This design is the strongest among the observational studies
• For example – to find out the relative risk of developing chronic obstructive pulmonary disease (COPD) among smokers, we take a sample including smokers and non-smokers. Then, we calculate the number of individuals with COPD among both.

Case-Control Study:

• We conduct this study by comparing 2 groups: one group with the disease (cases) and another group without the disease (controls)
• This design is always retrospective
•  We aim to find out the odds of having a risk factor or an exposure if an individual has a specific disease (Odds ratio)
•  Relatively easy to conduct
• For example – we want to study the odds of being a smoker among hypertensive patients compared to normotensive ones. To do so, we choose a group of patients diagnosed with hypertension and another group that serves as the control (normal blood pressure). Then we study their smoking history to find out if there is a correlation.

Experimental Studies

• Also known as interventional studies
• Can involve animals and humans
• Pre-clinical trials involve animals
• Clinical trials are experimental studies involving humans
• In clinical trials, we study the effect of an intervention compared to another intervention or placebo. As an example, I have listed the four phases of a drug trial:

I:  We aim to assess the safety of the drug ( is it safe ? )

II: We aim to assess the efficacy of the drug ( does it work ? )

III: We want to know if this drug is better than the old treatment ( is it better ? )

IV: We follow-up to detect long-term side effects ( can it stay in the market ? )

• In randomized controlled trials, one group of participants receives the control, while the other receives the tested drug/intervention. Those studies are the best way to evaluate the efficacy of a treatment.

Finally, the figure below will help you with your understanding of different types of study designs.

References (pdf)

You may also be interested in the following blogs for further reading:

An introduction to randomized controlled trials

Case-control and cohort studies: a brief overview

Cohort studies: prospective and retrospective designs

Prevalence vs Incidence: what is the difference?

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No Comments on An introduction to different types of study design

you are amazing one!! if I get you I’m working with you! I’m student from Ethiopian higher education. health sciences student

Very informative and easy understandable

You are my kind of doctor. Do not lose sight of your objective.

Wow very erll explained and easy to understand

I’m Khamisu Habibu community health officer student from Abubakar Tafawa Balewa university teaching hospital Bauchi, Nigeria, I really appreciate your write up and you have make it clear for the learner. thank you

well understood,thank you so much

Well understood…thanks

Simply explained. Thank You.

Thanks a lot for this nice informative article which help me to understand different study designs that I felt difficult before

That’s lovely to hear, Mona, thank you for letting the author know how useful this was. If there are any other particular topics you think would be useful to you, and are not already on the website, please do let us know.

it is very informative and useful.

thank you statistician

Fabulous to hear, thank you John.

Thanks for this information

Thanks so much for this information….I have clearly known the types of study design Thanks

That’s so good to hear, Mirembe, thank you for letting the author know.

Very helpful article!! U have simplified everything for easy understanding

I’m a health science major currently taking statistics for health care workers…this is a challenging class…thanks for the simified feedback.

That’s good to hear this has helped you. Hopefully you will find some of the other blogs useful too. If you see any topics that are missing from the website, please do let us know!

Hello. I liked your presentation, the fact that you ranked them clearly is very helpful to understand for people like me who is a novelist researcher. However, I was expecting to read much more about the Experimental studies. So please direct me if you already have or will one day. Thank you

Dear Ay. My sincere apologies for not responding to your comment sooner. You may find it useful to filter the blogs by the topic of ‘Study design and research methods’ – here is a link to that filter: https://s4be.cochrane.org/blog/topic/study-design/ This will cover more detail about experimental studies. Or have a look on our library page for further resources there – you’ll find that on the ‘Resources’ drop down from the home page.

However, if there are specific things you feel you would like to learn about experimental studies, that are missing from the website, it would be great if you could let me know too. Thank you, and best of luck. Emma

Great job Mr Hadi. I advise you to prepare and study for the Australian Medical Board Exams as soon as you finish your undergrad study in Lebanon. Good luck and hope we can meet sometime in the future. Regards ;)

You have give a good explaination of what am looking for. However, references am not sure of where to get them from.

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Study designs

This short article gives a brief guide to the different study types and a comparison of the advantages and disadvantages.

See also  Levels of Evidence  

These study designs all have similar components (as we’d expect from the PICO):

• A defined population (P) from which groups of subjects are studied
• Outcomes (O) that are measured

And for experimental and analytic observational studies:

• Interventions (I) or exposures (E) that are applied to different groups of subjects

Overview of the design tree

Figure 1 shows the tree of possible designs, branching into subgroups of study designs by whether the studies are descriptive or analytic and by whether the analytic studies are experimental or observational. The list is not completely exhaustive but covers most basics designs.

Figure: Tree of different types of studies (Q1, 2, and 3 refer to the three questions below)

> Download a PDF by Jeremy Howick about study designs

Our first distinction is whether the study is analytic or non-analytic. A  non-analytic  or  descriptive  study does not try to quantify the relationship but tries to give us a picture of what is happening in a population, e.g., the prevalence, incidence, or experience of a group. Descriptive studies include case reports, case-series, qualitative studies and surveys (cross-sectional) studies, which measure the frequency of several factors, and hence the size of the problem. They may sometimes also include analytic work (comparing factors “” see below).

An  analytic  study attempts to quantify the relationship between two factors, that is, the effect of an intervention (I) or exposure (E) on an outcome (O). To quantify the effect we will need to know the rate of outcomes in a comparison (C) group as well as the intervention or exposed group. Whether the researcher actively changes a factor or imposes uses an intervention determines whether the study is considered to be observational (passive involvement of researcher), or experimental (active involvement of researcher).

In  experimental  studies, the researcher manipulates the exposure, that is he or she allocates subjects to the intervention or exposure group. Experimental studies, or randomised controlled trials (RCTs), are similar to experiments in other areas of science. That is, subjects are allocated to two or more groups to receive an intervention or exposure and then followed up under carefully controlled conditions. Such studies controlled trials, particularly if randomised and blinded, have the potential to control for most of the biases that can occur in scientific studies but whether this actually occurs depends on the quality of the study design and implementation.

In  analytic observational  studies, the researcher simply measures the exposure or treatments of the groups. Analytical observational studies include case””control studies, cohort studies and some population (cross-sectional) studies. These studies all include matched groups of subjects and assess of associations between exposures and outcomes.

Observational studies investigate and record exposures (such as interventions or risk factors) and observe outcomes (such as disease) as they occur. Such studies may be purely descriptive or more analytical.

We should finally note that studies can incorporate several design elements. For example, a the control arm of a randomised trial may also be used as a cohort study; and the baseline measures of a cohort study may be used as a cross-sectional study.

Spotting the study design

The type of study can generally be worked at by looking at three issues (as per the Tree of design in Figure 1):

Q1. What was the aim of the study?

• To simply describe a population (PO questions) descriptive
• To quantify the relationship between factors (PICO questions) analytic.

Q2. If analytic, was the intervention randomly allocated?

• No? Observational study

For observational study the main types will then depend on the timing of the measurement of outcome, so our third question is:

Q3. When were the outcomes determined?

• Some time after the exposure or intervention? cohort study (‘prospective study’)
• At the same time as the exposure or intervention? cross sectional study or survey
• Before the exposure was determined? case-control study (‘retrospective study’ based on recall of the exposure)

Advantages and Disadvantages of the Designs

Randomised Controlled Trial

An experimental comparison study in which participants are allocated to treatment/intervention or control/placebo groups using a random mechanism (see randomisation). Best for study the effect of an intervention.

Advantages:

• unbiased distribution of confounders;
• blinding more likely;
• randomisation facilitates statistical analysis.

Disadvantages:

• expensive: time and money;
• volunteer bias;
• ethically problematic at times.

Crossover Design

A controlled trial where each study participant has both therapies, e.g, is randomised to treatment A first, at the crossover point they then start treatment B. Only relevant if the outcome is reversible with time, e.g, symptoms.

• all subjects serve as own controls and error variance is reduced thus reducing sample size needed;
• all subjects receive treatment (at least some of the time);
• statistical tests assuming randomisation can be used;
• blinding can be maintained.
• all subjects receive placebo or alternative treatment at some point;
• washout period lengthy or unknown;
• cannot be used for treatments with permanent effects

Cohort Study

Data are obtained from groups who have been exposed, or not exposed, to the new technology or factor of interest (eg from databases). No allocation of exposure is made by the researcher. Best for study the effect of predictive risk factors on an outcome.

• ethically safe;
• subjects can be matched;
• can establish timing and directionality of events;
• eligibility criteria and outcome assessments can be standardised;
• administratively easier and cheaper than RCT.
• controls may be difficult to identify;
• exposure may be linked to a hidden confounder;
• blinding is difficult;
• randomisation not present;
• for rare disease, large sample sizes or long follow-up necessary.

Case-Control Studies

Patients with a certain outcome or disease and an appropriate group of controls without the outcome or disease are selected (usually with careful consideration of appropriate choice of controls, matching, etc) and then information is obtained on whether the subjects have been exposed to the factor under investigation.

• quick and cheap;
• only feasible method for very rare disorders or those with long lag between exposure and outcome;
• fewer subjects needed than cross-sectional studies.
• reliance on recall or records to determine exposure status;
• confounders;
• selection of control groups is difficult;
• potential bias: recall, selection.

Cross-Sectional Survey

A study that examines the relationship between diseases (or other health-related characteristics) and other variables of interest as they exist in a defined population at one particular time (ie exposure and outcomes are both measured at the same time). Best for quantifying the prevalence of a disease or risk factor, and for quantifying the accuracy of a diagnostic test.

• cheap and simple;
• ethically safe.
• establishes association at most, not causality;
• recall bias susceptibility;
• confounders may be unequally distributed;
• Neyman bias;
• group sizes may be unequal.

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Types of Research – Explained with Examples

• By DiscoverPhDs
• October 2, 2020

Types of Research

Research is about using established methods to investigate a problem or question in detail with the aim of generating new knowledge about it.

It is a vital tool for scientific advancement because it allows researchers to prove or refute hypotheses based on clearly defined parameters, environments and assumptions. Due to this, it enables us to confidently contribute to knowledge as it allows research to be verified and replicated.

Knowing the types of research and what each of them focuses on will allow you to better plan your project, utilises the most appropriate methodologies and techniques and better communicate your findings to other researchers and supervisors.

Classification of Types of Research

There are various types of research that are classified according to their objective, depth of study, analysed data, time required to study the phenomenon and other factors. It’s important to note that a research project will not be limited to one type of research, but will likely use several.

According to its Purpose

Theoretical research.

Theoretical research, also referred to as pure or basic research, focuses on generating knowledge , regardless of its practical application. Here, data collection is used to generate new general concepts for a better understanding of a particular field or to answer a theoretical research question.

Results of this kind are usually oriented towards the formulation of theories and are usually based on documentary analysis, the development of mathematical formulas and the reflection of high-level researchers.

Applied Research

Here, the goal is to find strategies that can be used to address a specific research problem. Applied research draws on theory to generate practical scientific knowledge, and its use is very common in STEM fields such as engineering, computer science and medicine.

This type of research is subdivided into two types:

• Technological applied research : looks towards improving efficiency in a particular productive sector through the improvement of processes or machinery related to said productive processes.
• Scientific applied research : has predictive purposes. Through this type of research design, we can measure certain variables to predict behaviours useful to the goods and services sector, such as consumption patterns and viability of commercial projects.

According to your Depth of Scope

Exploratory research.

Exploratory research is used for the preliminary investigation of a subject that is not yet well understood or sufficiently researched. It serves to establish a frame of reference and a hypothesis from which an in-depth study can be developed that will enable conclusive results to be generated.

Because exploratory research is based on the study of little-studied phenomena, it relies less on theory and more on the collection of data to identify patterns that explain these phenomena.

Descriptive Research

The primary objective of descriptive research is to define the characteristics of a particular phenomenon without necessarily investigating the causes that produce it.

In this type of research, the researcher must take particular care not to intervene in the observed object or phenomenon, as its behaviour may change if an external factor is involved.

Explanatory Research

Explanatory research is the most common type of research method and is responsible for establishing cause-and-effect relationships that allow generalisations to be extended to similar realities. It is closely related to descriptive research, although it provides additional information about the observed object and its interactions with the environment.

Correlational Research

The purpose of this type of scientific research is to identify the relationship between two or more variables. A correlational study aims to determine whether a variable changes, how much the other elements of the observed system change.

According to the Type of Data Used

Qualitative research.

Qualitative methods are often used in the social sciences to collect, compare and interpret information, has a linguistic-semiotic basis and is used in techniques such as discourse analysis, interviews, surveys, records and participant observations.

In order to use statistical methods to validate their results, the observations collected must be evaluated numerically. Qualitative research, however, tends to be subjective, since not all data can be fully controlled. Therefore, this type of research design is better suited to extracting meaning from an event or phenomenon (the ‘why’) than its cause (the ‘how’).

Quantitative Research

Quantitative research study delves into a phenomena through quantitative data collection and using mathematical, statistical and computer-aided tools to measure them . This allows generalised conclusions to be projected over time.

According to the Degree of Manipulation of Variables

Experimental research.

It is about designing or replicating a phenomenon whose variables are manipulated under strictly controlled conditions in order to identify or discover its effect on another independent variable or object. The phenomenon to be studied is measured through study and control groups, and according to the guidelines of the scientific method.

Non-Experimental Research

Also known as an observational study, it focuses on the analysis of a phenomenon in its natural context. As such, the researcher does not intervene directly, but limits their involvement to measuring the variables required for the study. Due to its observational nature, it is often used in descriptive research.

Quasi-Experimental Research

It controls only some variables of the phenomenon under investigation and is therefore not entirely experimental. In this case, the study and the focus group cannot be randomly selected, but are chosen from existing groups or populations . This is to ensure the collected data is relevant and that the knowledge, perspectives and opinions of the population can be incorporated into the study.

According to the Type of Inference

Deductive investigation.

In this type of research, reality is explained by general laws that point to certain conclusions; conclusions are expected to be part of the premise of the research problem and considered correct if the premise is valid and the inductive method is applied correctly.

Inductive Research

In this type of research, knowledge is generated from an observation to achieve a generalisation. It is based on the collection of specific data to develop new theories.

Hypothetical-Deductive Investigation

It is based on observing reality to make a hypothesis, then use deduction to obtain a conclusion and finally verify or reject it through experience.

According to the Time in Which it is Carried Out

Longitudinal study (also referred to as diachronic research).

It is the monitoring of the same event, individual or group over a defined period of time. It aims to track changes in a number of variables and see how they evolve over time. It is often used in medical, psychological and social areas .

Cross-Sectional Study (also referred to as Synchronous Research)

Cross-sectional research design is used to observe phenomena, an individual or a group of research subjects at a given time.

According to The Sources of Information

Primary research.

This fundamental research type is defined by the fact that the data is collected directly from the source, that is, it consists of primary, first-hand information.

Secondary research

Unlike primary research, secondary research is developed with information from secondary sources, which are generally based on scientific literature and other documents compiled by another researcher.

According to How the Data is Obtained

Documentary (cabinet).

Documentary research, or secondary sources, is based on a systematic review of existing sources of information on a particular subject. This type of scientific research is commonly used when undertaking literature reviews or producing a case study.

Field research study involves the direct collection of information at the location where the observed phenomenon occurs.

From Laboratory

Laboratory research is carried out in a controlled environment in order to isolate a dependent variable and establish its relationship with other variables through scientific methods.

Mixed-Method: Documentary, Field and/or Laboratory

Mixed research methodologies combine results from both secondary (documentary) sources and primary sources through field or laboratory research.

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Evidence-Based Medicine: Types of Studies

• What is Evidence-Based Practice?
• Question Types and Corresponding Resources
• Types of Studies
• Practice Guidelines
• Step 3: Appraise This link opens in a new window
• Steps 4-5: Apply & Assess

Experimental vs. Observational Studies

An observational study is a study in which the investigator cannot control the assignment of treatment to subjects because the participants or conditions are not directly assigned by the researcher.

• Examines predetermined treatments, interventions, policies, and their effects
• Four main types: case series , case-control studies , cross-sectional studies , and cohort studies

In an experimental study , the investigators directly manipulate or assign participants to different interventions or environments

Experimental studies that involve humans are called clinical trials . They fall into two categories: those with controls, and those without controls.

• Controlled trials - studies in which the experimental drug or procedure is compared with another drug or procedure
• Uncontrolled trials - studies in which the investigators' experience with the experimental drug or procedure is described, but the treatment is not compared with another treatment

Definitions taken from: Dawson B, Trapp R.G. (2004). Chapter 2. Study Designs in Medical Research. In Dawson B, Trapp R.G. (Eds), Basic & Clinical Biostatistics, 4e . Retrieved September 15, 2014 from  https://accessmedicine.mhmedical.com/book.aspx?bookid=2724

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Study Design 101 : Himmelfarb's tutorial on study types and how to find them

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Types of Study in Medical Research

Part 3 of a Series on Evaluation of Scientific Publications

Bernd Röhrig , Dr. rer. nat.

Jean-baptist du prel , dr. med., daniel wachtlin, maria blettner , prof. dr. rer. nat..

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*MDK Rheinland-Pfalz, Referat Rehabilitation/Biometrie, Albiger Str. 19 d, 55232 Alzey, Germany, [email protected]

Received 2008 Jun 30; Accepted 2008 Nov 13; Issue date 2009 Apr.

The choice of study type is an important aspect of the design of medical studies. The study design and consequent study type are major determinants of a study’s scientific quality and clinical value.

This article describes the structured classification of studies into two types, primary and secondary, as well as a further subclassification of studies of primary type. This is done on the basis of a selective literature search concerning study types in medical research, in addition to the authors’ own experience.

Three main areas of medical research can be distinguished by study type: basic (experimental), clinical, and epidemiological research. Furthermore, clinical and epidemiological studies can be further subclassified as either interventional or noninterventional.

Conclusions

The study type that can best answer the particular research question at hand must be determined not only on a purely scientific basis, but also in view of the available financial resources, staffing, and practical feasibility (organization, medical prerequisites, number of patients, etc.).

Keywords: study type, basic research, clinical research, epidemiology, literature search

The quality, reliability and possibility of publishing a study are decisively influenced by the selection of a proper study design. The study type is a component of the study design (see the article "Study Design in Medical Research") and must be specified before the study starts. The study type is determined by the question to be answered and decides how useful a scientific study is and how well it can be interpreted. If the wrong study type has been selected, this cannot be rectified once the study has started.

After an earlier publication dealing with aspects of study design, the present article deals with study types in primary and secondary research. The article focuses on study types in primary research. A special article will be devoted to study types in secondary research, such as meta-analyses and reviews. This article covers the classification of individual study types. The conception, implementation, advantages, disadvantages and possibilities of using the different study types are illustrated by examples. The article is based on a selective literature research on study types in medical research, as well as the authors’ own experience.

Classification of study types

In principle, medical research is classified into primary and secondary research. While secondary research summarizes available studies in the form of reviews and meta-analyses, the actual studies are performed in primary research. Three main areas are distinguished: basic medical research, clinical research, and epidemiological research. In individual cases, it may be difficult to classify individual studies to one of these three main categories or to the subcategories. In the interests of clarity and to avoid excessive length, the authors will dispense with discussing special areas of research, such as health services research, quality assurance, or clinical epidemiology. Figure 1 gives an overview of the different study types in medical research.

Classification of different study types

*1 , sometimes known as experimental research; *2 , analogous term: interventional; *3 , analogous term: noninterventional or nonexperimental

This scheme is intended to classify the study types as clearly as possible. In the interests of clarity, we have excluded clinical epidemiology — a subject which borders on both clinical and epidemiological research ( 3 ). The study types in this area can be found under clinical research and epidemiology.

Basic research

Basic medical research (otherwise known as experimental research) includes animal experiments, cell studies, biochemical, genetic and physiological investigations, and studies on the properties of drugs and materials. In almost all experiments, at least one independent variable is varied and the effects on the dependent variable are investigated. The procedure and the experimental design can be precisely specified and implemented ( 1 ). For example, the population, number of groups, case numbers, treatments and dosages can be exactly specified. It is also important that confounding factors should be specifically controlled or reduced. In experiments, specific hypotheses are investigated and causal statements are made. High internal validity (= unambiguity) is achieved by setting up standardized experimental conditions, with low variability in the units of observation (for example, cells, animals or materials). External validity is a more difficult issue. Laboratory conditions cannot always be directly transferred to normal clinical practice and processes in isolated cells or in animals are not equivalent to those in man (= generalizability) ( 2 ).

Basic research also includes the development and improvement of analytical procedures—such as analytical determination of enzymes, markers or genes—, imaging procedures—such as computed tomography or magnetic resonance imaging—, and gene sequencing—such as the link between eye color and specific gene sequences. The development of biometric procedures—such as statistical test procedures, modeling and statistical evaluation strategies—also belongs here.

Clinical studies

Clinical studies include both interventional (or experimental) studies and noninterventional (or observational) studies. A clinical drug study is an interventional clinical study, defined according to §4 Paragraph 23 of the Medicines Act [Arzneimittelgesetz; AMG] as "any study performed on man with the purpose of studying or demonstrating the clinical or pharmacological effects of drugs, to establish side effects, or to investigate absorption, distribution, metabolism or elimination, with the aim of providing clear evidence of the efficacy or safety of the drug."

Interventional studies also include studies on medical devices and studies in which surgical, physical or psychotherapeutic procedures are examined. In contrast to clinical studies, §4 Paragraph 23 of the AMG describes noninterventional studies as follows: "A noninterventional study is a study in the context of which knowledge from the treatment of persons with drugs in accordance with the instructions for use specified in their registration is analyzed using epidemiological methods. The diagnosis, treatment and monitoring are not performed according to a previously specified study protocol, but exclusively according to medical practice."

The aim of an interventional clinical study is to compare treatment procedures within a patient population, which should exhibit as few as possible internal differences, apart from the treatment ( 4 , e1 ). This is to be achieved by appropriate measures, particularly by random allocation of the patients to the groups, thus avoiding bias in the result. Possible therapies include a drug, an operation, the therapeutic use of a medical device such as a stent, or physiotherapy, acupuncture, psychosocial intervention, rehabilitation measures, training or diet. Vaccine studies also count as interventional studies in Germany and are performed as clinical studies according to the AMG.

Interventional clinical studies are subject to a variety of legal and ethical requirements, including the Medicines Act and the Law on Medical Devices. Studies with medical devices must be registered by the responsible authorities, who must also approve studies with drugs. Drug studies also require a favorable ruling from the responsible ethics committee. A study must be performed in accordance with the binding rules of Good Clinical Practice (GCP) ( 5 , e2 – e4 ). For clinical studies on persons capable of giving consent, it is absolutely essential that the patient should sign a declaration of consent (informed consent) ( e2 ). A control group is included in most clinical studies. This group receives another treatment regimen and/or placebo—a therapy without substantial efficacy. The selection of the control group must not only be ethically defensible, but also be suitable for answering the most important questions in the study ( e5 ).

Clinical studies should ideally include randomization, in which the patients are allocated by chance to the therapy arms. This procedure is performed with random numbers or computer algorithms ( 6 – 8 ). Randomization ensures that the patients will be allocated to the different groups in a balanced manner and that possible confounding factors—such as risk factors, comorbidities and genetic variabilities—will be distributed by chance between the groups (structural equivalence) ( 9 , 10 ). Randomization is intended to maximize homogeneity between the groups and prevent, for example, a specific therapy being reserved for patients with a particularly favorable prognosis (such as young patients in good physical condition) ( 11 ).

Blinding is another suitable method to avoid bias. A distinction is made between single and double blinding. With single blinding, the patient is unaware which treatment he is receiving, while, with double blinding, neither the patient nor the investigator knows which treatment is planned. Blinding the patient and investigator excludes possible subjective (even subconscious) influences on the evaluation of a specific therapy (e.g. drug administration versus placebo). Thus, double blinding ensures that the patient or therapy groups are both handled and observed in the same manner. The highest possible degree of blinding should always be selected. The study statistician should also remain blinded until the details of the evaluation have finally been specified.

A well designed clinical study must also include case number planning. This ensures that the assumed therapeutic effect can be recognized as such, with a previously specified statistical probability (statistical power) ( 4 , 6 , 12 ).

It is important for the performance of a clinical trial that it should be carefully planned and that the exact clinical details and methods should be specified in the study protocol ( 13 ). It is, however, also important that the implementation of the study according to the protocol, as well as data collection, must be monitored. For a first class study, data quality must be ensured by double data entry, programming plausibility tests, and evaluation by a biometrician. International recommendations for the reporting of randomized clinical studies can be found in the CONSORT statement (Consolidated Standards of Reporting Trials, www.consort-statement.org ) ( 14 ). Many journals make this an essential condition for publication.

For all the methodological reasons mentioned above and for ethical reasons, the randomized controlled and blinded clinical trial with case number planning is accepted as the gold standard for testing the efficacy and safety of therapies or drugs ( 4 , e1 , 15 ).

In contrast, noninterventional clinical studies (NIS) are patient-related observational studies, in which patients are given an individually specified therapy. The responsible physician specifies the therapy on the basis of the medical diagnosis and the patient’s wishes. NIS include noninterventional therapeutic studies, prognostic studies, observational drug studies, secondary data analyses, case series and single case analyses ( 13 , 16 ). Similarly to clinical studies, noninterventional therapy studies include comparison between therapies; however, the treatment is exclusively according to the physician’s discretion. The evaluation is often retrospective. Prognostic studies examine the influence of prognostic factors (such as tumor stage, functional state, or body mass index) on the further course of a disease. Diagnostic studies are another class of observational studies, in which either the quality of a diagnostic method is compared to an established method (ideally a gold standard), or an investigator is compared with one or several other investigators (inter-rater comparison) or with himself at different time points (intra-rater comparison) ( e1 ). If an event is very rare (such as a rare disease or an individual course of treatment), a single-case study, or a case series, are possibilities. A case series is a study on a larger patient group with a specific disease. For example, after the discovery of the AIDS virus, the Center for Disease Control (CDC) in the USA collected a case series of 1000 patients, in order to study frequent complications of this infection. The lack of a control group is a disadvantage of case series. For this reason, case series are primarily used for descriptive purposes ( 3 ).

Epidemiological studies

The main point of interest in epidemiological studies is to investigate the distribution and historical changes in the frequency of diseases and the causes for these. Analogously to clinical studies, a distinction is made between experimental and observational epidemiological studies ( 16 , 17 ).

Interventional studies are experimental in character and are further subdivided into field studies (sample from an area, such as a large region or a country) and group studies (sample from a specific group, such as a specific social or ethnic group). One example was the investigation of the iodine supplementation of cooking salt to prevent cretinism in a region with iodine deficiency. On the other hand, many interventions are unsuitable for randomized intervention studies, for ethical, social or political reasons, as the exposure may be harmful to the subjects ( 17 ).

Observational epidemiological studies can be further subdivided into cohort studies (follow-up studies), case control studies, cross-sectional studies (prevalence studies), and ecological studies (correlation studies or studies with aggregated data).

In contrast, studies with only descriptive evaluation are restricted to a simple depiction of the frequency (incidence and prevalence) and distribution of a disease within a population. The objective of the description may also be the regular recording of information (monitoring, surveillance). Registry data are also suited for the description of prevalence and incidence; for example, they are used for national health reports in Germany.

In the simplest case, cohort studies involve the observation of two healthy groups of subjects over time. One group is exposed to a specific substance (for example, workers in a chemical factory) and the other is not exposed. It is recorded prospectively (into the future) how often a specific disease (such as lung cancer) occurs in the two groups ( figure 2a ). The incidence for the occurrence of the disease can be determined for both groups. Moreover, the relative risk (quotient of the incidence rates) is a very important statistical parameter which can be calculated in cohort studies. For rare types of exposure, the general population can be used as controls ( e6 ). All evaluations naturally consider the age and gender distributions in the corresponding cohorts. The objective of cohort studies is to record detailed information on the exposure and on confounding factors, such as the duration of employment, the maximum and the cumulated exposure. One well known cohort study is the British Doctors Study, which prospectively examined the effect of smoking on mortality among British doctors over a period of decades ( e7 ). Cohort studies are well suited for detecting causal connections between exposure and the development of disease. On the other hand, cohort studies often demand a great deal of time, organization, and money. So-called historical cohort studies represent a special case. In this case, all data on exposure and effect (illness) are already available at the start of the study and are analyzed retrospectively. For example, studies of this sort are used to investigate occupational forms of cancer. They are usually cheaper ( 16 ).

Graphical depiction of a prospective cohort study (simplest case [2a]) and a retrospective case control study (2b)

In case control studies, cases are compared with controls. Cases are persons who fall ill from the disease in question. Controls are persons who are not ill, but are otherwise comparable to the cases. A retrospective analysis is performed to establish to what extent persons in the case and control groups were exposed ( figure 2b ). Possible exposure factors include smoking, nutrition and pollutant load. Care should be taken that the intensity and duration of the exposure is analyzed as carefully and in as detailed a manner as possible. If it is observed that ill people are more often exposed than healthy people, it may be concluded that there is a link between the illness and the risk factor. In case control studies, the most important statistical parameter is the odds ratio. Case control studies usually require less time and fewer resources than cohort studies ( 16 ). The disadvantage of case control studies is that the incidence rate (rate of new cases) cannot be calculated. There is also a great risk of bias from the selection of the study population ("selection bias") and from faulty recall ("recall bias") (see too the article "Avoiding Bias in Observational Studies"). Table 1 presents an overview of possible types of epidemiological study ( e8 ). Table 2 summarizes the advantages and disadvantages of observational studies ( 16 ).

Table 1. Specially well suited study types for epidemiological investigations (taken from [ e8 ]).

Table 2. advantages and disadvantages of observational studies (taken from [ 16 ])*..

1 = slight; 2 = moderate; 3 = high; N/A, not applicable.

*Individual cases may deviate from this pattern.

Selecting the correct study type is an important aspect of study design (see "Study Design in Medical Research" in volume 11/2009). However, the scientific questions can only be correctly answered if the study is planned and performed at a qualitatively high level ( e9 ). It is very important to consider or even eliminate possible interfering factors (or confounders), as otherwise the result cannot be adequately interpreted. Confounders are characteristics which influence the target parameters. Although this influence is not of primary interest, it can interfere with the connection between the target parameter and the factors that are of interest. The influence of confounders can be minimized or eliminated by standardizing the procedure, stratification ( 18 ), or adjustment ( 19 ).

The decision as to which study type is suitable to answer a specific primary research question must be based not only on scientific considerations, but also on issues related to resources (personnel and finances), hospital capacity, and practicability. Many epidemiological studies can only be implemented if there is access to registry data. The demands for planning, implementation, and statistical evaluation for observational studies should be just as high for observational studies as for experimental studies. There are particularly strict requirements, with legally based regulations (such as the Medicines Act and Good Clinical Practice), for the planning, implementation, and evaluation of clinical studies. A study protocol must be prepared for both interventional and noninterventional studies ( 6 , 13 ). The study protocol must contain information on the conditions, question to be answered (objective), the methods of measurement, the implementation, organization, study population, data management, case number planning, the biometric evaluation, and the clinical relevance of the question to be answered ( 13 ).

Important and justified ethical considerations may restrict studies with optimal scientific and statistical features. A randomized intervention study under strictly controlled conditions of the effect of exposure to harmful factors (such as smoking, radiation, or a fatty diet) is not possible and not permissible for ethical reasons. Observational studies are a possible alternative to interventional studies, even though observational studies are less reliable and less easy to control ( 17 ).

A medical study should always be published in a peer reviewed journal. Depending on the study type, there are recommendations and checklists for presenting the results. For example, these may include a description of the population, the procedure for missing values and confounders, and information on statistical parameters. Recommendations and guidelines are available for clinical studies ( 14 , 20 , e10 , e11 ), for diagnostic studies ( 21 , 22 , e12 ), and for epidemiological studies ( 23 , e13 ). Since 2004, the WHO has demanded that studies should be registered in a public registry, such as www.controlled-trials.com or www.clinicaltrials.gov . This demand is supported by the International Committee of Medical Journal Editors (ICMJE) ( 24 ), which specifies that the registration of the study before inclusion of the first subject is an essential condition for the publication of the study results ( e14 ).

When specifying the study type and study design for medical studies, it is essential to collaborate with an experienced biometrician. The quality and reliability of the study can be decisively improved if all important details are planned together ( 12 , 25 ).

Acknowledgments

Translated from the original German by Rodney A. Yeates, M.A., Ph.D.

Conflict of interest statement

The authors declare that there is no conflict of interest in the sense of the International Committee of Medical Journal Editors.

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