Every clinical trial is designed to look at a specific population, so each participant is required to have certain traits (eligibility criteria) in order to take part in the study.1,2
Eligibility for study participation
In order to participate in a clinical trial, a person must meet certain eligibility criteria, and these criteria are different for each study. For instance, some studies are designed to examine a specific treatment in people with a specific disease or condition, while others may only want healthy participants. The term "inclusion criteria" refers to the factors that qualify someone for a study, while "exclusion criteria" indicate factors that would prevent a person from study participation. These factors may include characteristics like age, gender, previous treatment history, other medical conditions, disease severity, etc.
Study protocol
Clinical trials are required to follow a very strict protocol, which is designed to protect participants and also to help produce reliable study results. Every clinical trial is led by a Principle Investigator (PI), who is typically a doctor. The protocol for the clinical trial is prepared by the PI.
The study protocol will include the following:
- The reason for conducting the study
- Who is eligible to participate in the study
- The number of participants needed for the study
- The schedule of tests, procedures, or drugs and their dosages
- The duration of the study
- The information that will be collected about the participants
Protecting participants of clinical trials
Prior to enrolling, all participants will be provided information about the study that will help them determine whether they want to enroll or continue to participate in the study. This process, known as “informed consent”, provides information to study participants so that they understand the potential risks, benefits, and alternatives to the study. Prior to enrollment, participants will be required to sign the informed consent document. It is important for participants to understand that this is not a contract, and that they have the right to withdraw from a study at any time.
Institutional review boards
All studies of a drug, biological product, or medical device regulated by the FDA, as well as any federally supported or conducted clinical study, are required to be reviewed, approved, and monitored by an institutional review board (IRB). An IRB is responsible for making sure that the study is conducted in an ethical manner and that the rights and best interest of the participants are protected. An IRB includes physicians, researchers, and community members.
Participating in a clinical trial
A variety of healthcare providers may be involved in the participant’s care during a clinical trial. The assigned healthcare team will be responsible for conducting a variety of exams or tests, as well as closely monitoring the health of every participant. This monitoring may be more extensive than what one typically experiences in a standard doctor visit.
Benefits and risks of participating in a clinical trial
There are many potential benefits to participating in a clinical trial, but there are also risks.
Participating in a clinical trial may provide access to new, efficacious treatments that are not yet available to the general public. For those who participate in a clinical trial but do not receive the new treatment being studied, they will still receive the current standard of care. Further, the health of study participants is monitored closely. In addition to benefits to the individual, participating in a clinical trial provides information to study investigators, increasing the current knowledge base around the condition.
There are, of course, risks in participating in clinical trials.
There may be unknown risks and side effects associated with a new drug that is being studied, and these risks are greater for the early Phase 1 and Phase 2 trials. There is also no guarantee that the new drug being studied will be better than, or even as good as the current standard of care. Unfortunately, there may also be costs associated with participating in a clinical trial, as health insurance and healthcare providers may not cover all patient care costs, so it’s important to find out about costs and coverage ahead of time.