What Is a Clinical Study?

A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge.
There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies.

Clinical Trials
In a clinical trial, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or changes to participants’ behavior, such as diet.

Clinical trials may compare a new medical approach to a standard one that is already available, to a placebo that contains no active ingredients, or to no intervention.

Some clinical trials compare interventions that are already available to each other. When a new product or approach is being studied, it is not usually known whether it will be helpful, harmful, or no different than available alternatives (including no intervention).

The investigators try to determine the safety and efficacy of the intervention by measuring certain outcomes in the participants. For example, investigators may give a drug or treatment to participants who have high blood pressure to see whether their blood pressure decreases.

Clinical trials used in drug development are sometimes described by phase.

Some people who are not eligible to participate in a clinical trial may be able to get experimental drugs or devices outside of a clinical trial through an Expanded Access Program.

Observational Studies

In an observational study, investigators assess health outcomes in groups of participants according to a research plan or protocol. Participants may receive interventions (which can include medical products such as drugs or devices) or procedures as part of their routine medical care, but participants are not assigned to specific interventions by the investigator (as in a clinical trial). For example, investigators may observe a group of older adults to learn more about the effects of different lifestyles on cardiac health.

Who Conducts Clinical Studies?

Every clinical study is led by a principal investigator, who is often a medical doctor. Clinical studies also have a research team that may include doctors, nurses, social workers, and other health care professionals.
Clinical studies can be sponsored, or funded, by pharmaceutical companies, academic medical centers, voluntary groups, and other organizations, in addition to Federal agencies such as the National Institutes of Health, the U.S. Department of Defense, and the U.S. Department of Veterans Affairs. Physicians, health care providers, and other individuals can also sponsor clinical research.

Where Are Clinical Studies Conducted?
Clinical studies can take place in many locations, including hospitals, universities, doctors’ offices, and community clinics. The location depends on who is conducting the study.

How Long Do Clinical Studies Last?
The length of a clinical study varies depending on what is being studied. Participants are told how long the study will last before enrollment.

Reasons for Conducting Clinical Studies
In general, clinical studies are designed to add to medical knowledge related to the treatment, diagnosis, and prevention of diseases or conditions. Some common reasons for conducting clinical studies include:

Evaluating one or more interventions (for example, drugs, medical devices, approaches to surgery or radiation therapy) for treating a disease, syndrome, or condition
Finding ways to prevent the initial development or recurrence of a disease or condition. These can include medicines, vaccines, or lifestyle changes, among other approaches.
Evaluating one or more interventions aimed at identifying or diagnosing a particular disease or condition
Examining methods for identifying a condition or the risk factors for that condition
Exploring and measuring ways to improve the comfort and quality of life through supportive care for people with a chronic illness.

Part 2 to follow.

G Mohan.