What is a clinical trial?

A clinical trial involves research using volunteers (also called participants) that is intended to add to medical knowledge.  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, vaccines 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.

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 medication 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. These phases are defined by the Food and Drug Administration (FDA).

Is it safe to participate in a clinical trial?

Each federally supported or conducted clinical study and each study of a drug, biological product, or medical device regulated by FDA must be reviewed, approved, and monitored by an institutional review board (IRB). An IRB is made up of doctors, researchers, and members of the community.

Its role is to make sure that the study is ethical and that the rights and welfare of participants are protected. This includes making sure that research risks are minimized and are reasonable in relation to any potential benefits, among other responsibilities. The IRB also reviews the informed consent document.

In addition to being monitored by an IRB, some clinical studies are also monitored by data monitoring committees (also called data safety and monitoring boards).

Various Federal agencies, including the Office of Human Subjects Research Protection and the FDA, have the authority to determine whether sponsors of certain clinical studies are adequately protecting research participants.

How much do research participants get paid?

It is customary to pay research volunteers for their time and travel while participating in a clinical research trial.  Most commonly, volunteers must be screened to see if they fit the type of subject the protocol has outlined.  This may include health related questions, age, gender, medications, etc., among other qualifiers.  Each study is looking for very specific groups of people to participate so that any variables can be minimized.  The criteria will change from study to study.

Based on the length of the study, the amount of time each office visit requires, and the level of testing (i.e., completing simple surveys or experiencing multiple blood draws, for example), the cost per visit will vary.  Typically, study visits will pay $50 to $150 per visit with lesser amounts provided for daily/weekly electronic diary completion.

What is participating in a clinical study all about?

A clinical study is conducted according to a research plan known as the protocol. The protocol is designed to answer specific research questions and safeguard the health of participants. It contains the following information:

• The reason for conducting the study.

• Who may participate in the study (the eligibility criteria).

• The number of participants needed.

• The schedule of tests, procedures, or drugs and their dosages.

• The length of the study.

• What information will be gathered about the participants.

Who can participate in a clinical study?

Clinical studies have standards outlining who can participate. These standards are called eligibility criteria and are listed in the protocol. Some research studies seek participants who have the illnesses or conditions that will be studied, other studies are looking for healthy participants, and some studies are limited to a predetermined group of people who are asked by researchers to enroll.

What is the eligibility for participating in a study?

The factors that allow someone to participate in a clinical study are called inclusion criteria, and the factors that disqualify someone from participating are called exclusion criteria. They are based on characteristics such as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. Many studies are looking for participants that are basically healthy subjects with no significant uncontrolled health conditions.

What is the relationship with usual health care?

Typically, participants continue to see their usual health care providers while enrolled in a clinical study. While most clinical studies provide participants with medical products or interventions related to the illness or condition being studied, they do not provide extended or complete health care.

By having his or her usual health care provider work with the research team, a participant can make sure that the study protocol will not conflict with other medications or treatments that he or she receives.

What are the considerations for participation?

Participating in a clinical study contributes to medical knowledge. The results of these studies can make a difference in the care of future patients by providing information about the benefits and risks of therapeutic, preventative, or diagnostic products or interventions.

Clinical trials provide the basis for the development and marketing of new drugs, biological products, and medical devices. Sometimes, the safety and the effectiveness of the experimental approach or use may not be fully known at the time of the trial.

Some trials may provide participants with the prospect of receiving direct medical benefits, while others do not. Most trials involve some risk of harm to the participant, although it may not be greater than the risks related to routine medical care or disease progression. All of the trials are approved by IRBs where the IRB has decided that the risks of participation have been minimized and are reasonable in relation to anticipated benefits.

Many trials require participants to undergo additional procedures, tests, and assessments based on the study protocol. These requirements will be described in the informed consent document. A potential participant should also discuss these issues with members of the research team and with his or her usual health care provider.