Wondering what is clinical research, and whether it could be your field? It is the study of health and disease in people, from watching patterns to testing new treatments, and it is how medicine learns what works.
This guide is part of our look at the biotech industry, and it covers the basics for career-curious readers.
| Item | Value |
|---|---|
| Main study types on ClinicalTrials.gov | 2 (observational studies and clinical trials) |
| Questions in the NIH clinical trial test | 4 |
| FDA’s sample categories of clinical research | 7 |
These figures come from the NCATS glossary entry on clinical research and the NDSU guide to NIH’s clinical trial questions. Definitions and policies can change, so check the source before you rely on them.
What clinical research actually covers
Clinical research is research that involves people. Laboratory work on cells or animals can inform human studies and can also continue alongside or after them.
The term is broader than “clinical trial”. A trial is one kind of clinical research, and many studies never test a drug or device. Some simply follow people over time, review health records, or compare outcomes between groups.
Several organisations slice the field differently, which can confuse newcomers. The next sections show the main ways of sorting it.
A useful habit is to ask two questions of any study you read about. Who are the participants, and did the researchers assign them to something? Those answers help classify a study, but distinguishing a clinical trial from basic experimental research also requires examining its purpose and outcomes.
The answers also shape the work behind the study. A trial needs a written protocol, trained site staff, careful record keeping and a plan for analysing results before the first participant enrols. An observational study may lean more on data quality, record access and statistical methods.
The main types of clinical research
The NCATS glossary notes that ClinicalTrials.gov states two main types of clinical research: observational studies (such as a natural history study) and clinical trials, also known as interventional studies.
The difference is whether researchers assign participants to the intervention being studied. In an observational study, data are gathered from or about people without researchers assigning the intervention being studied; participants may receive interventions through routine care. In a trial, people are assigned to an intervention so the team can measure its effect.
The FDA lists several categories based on what the researcher is studying. According to the same glossary, they include:
- Treatment research
- Prevention research
- Diagnostic research
- Screening research
- Quality of life research
- Genetic studies
- Epidemiological studies
For grant purposes, NIH sorts clinical research into three areas: patient-oriented research; epidemiologic and behavioral studies; and outcomes and health services research.
How a study counts as a clinical trial
Funders and regulators need a clear line between a trial and everything else. NIH draws it with four questions, as summarised in NDSU’s guide to NIH’s rules.
- Does the study involve human participants?
- Are the participants prospectively assigned to an intervention?
- Is the study designed to evaluate the effect of the intervention on the participants?
- Is the effect being evaluated a health-related biomedical or behavioral outcome?
NIH’s own definition describes a clinical trial as a study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.
The same guide separates trials from two neighbours. Basic experimental studies involving humans (BESH) aim at understanding fundamental aspects of phenomena without a direct application towards clinical processes or products. Observational studies gather data without researchers assigning the intervention being studied; participants may receive interventions through routine care.
Interventions are not only drugs. The guide lists biologics, devices, surgical procedures, delivery systems, strategies to change health-related behavior such as diet or exercise, and treatment, prevention or diagnostic strategies.
How participants are protected
Research on people raises ethical duties, and the rules reflect that. In the United States, studies regulated by the FDA rely on informed consent and on review by institutional review boards (IRBs).
RAPS reported that the FDA finalised guidance on 15 August 2023 to help IRBs, clinical investigators and sponsors comply with informed consent regulations for clinical investigations. The guidance covers exceptions to consent, avoiding coercion and undue influence, and making language understandable to the participant or legally authorized representative.
It also discusses the basic elements of consent. These include describing the clinical investigation, explaining the risks and discomforts as well as the benefits, and addressing compensation and medical treatment in the event of an injury. The text is from the RAPS report on the guidance.
The roles are split on purpose. Investigators run the study, sponsors fund and organise it, IRBs review it, and the FDA oversees the regulated products. Each check exists so that no single party marks its own homework.
Why clinical research matters, and where careers fit
Without human studies, a treatment is only a hypothesis. Clinical research is where safety and benefit are measured, and where a therapy either earns the evidence it needs or is set aside.
The results feed directly into what regulators and doctors can say about a product. If you want to see how a successful study turns into a marketed product, read about the fda approval process. To see how trials are staged from early safety work to large confirmatory studies, read about the clinical trial phases.
For readers weighing a career, this matters because the work is rarely glamorous but requires careful checking. Accuracy, documentation and patience count for as much as scientific flair, and the same habits carry across roles and employers.
A study needs many kinds of people, which is why the field suits a range of backgrounds. Typical roles include:
- Clinical research coordinators, who run day-to-day study visits
- Clinical research associates, who monitor that sites follow the protocol
- Data managers and biostatisticians, who handle and analyse results
- Regulatory affairs and quality specialists, who keep documents and processes compliant
- Medical writers, who turn study findings into reports and publications
This site is independent and educational. It is not affiliated with any organisation named here, and it does not recruit, advise or take enquiries.
Frequently asked questions
Is clinical research the same as a clinical trial?
Show answer
No. A clinical trial is one type of clinical research. Observational studies, which gather data without researchers assigning the intervention being studied, are the other main type listed on ClinicalTrials.gov, according to the NCATS glossary. Participants may receive interventions through routine care.
Does a clinical trial need a placebo group?
Show answer
No. NIH’s definition says interventions may include a placebo or other control, so a control is allowed rather than required.
Who reviews a study before it starts?
Show answer
Many studies involving people require institutional review board review; some research qualifies for exemption. The FDA’s informed consent guidance, as reported by RAPS in August 2023, addresses the roles of IRBs, investigators, sponsors and the FDA.
Do I need to be a doctor to work in clinical research?
Show answer
No. Studies rely on coordinators, data specialists, regulatory staff and writers as well as physicians. The roles above are examples, and requirements differ by employer and country.
