Clinical trials are research studies conducted by doctors and scientists to discover new and better ways of treating patients. These trials involve volunteers who participate in the study to advance scientific knowledge and improve patient care. Every drug that is approved by the FDA has been tested in a clinical trial.

Clinical trials cover all types and stages of prevention and cancer. They focus on new treatments and evaluate the safety and efficacy of new drugs, different combinations of treatments, new approaches to radiation therapy or surgery, and new methods of treatment. Participants in clinical trials may have the opportunity to receive treatment before it is available to the public. However, there are potential risks and side effects associated with participating in clinical trials, and patients should discuss the pros and cons with their healthcare provider before joining a study.

Clinical trials focus on ways to relieve symptoms and side effects during treatment or manage late effects that may occur long after treatment. Patients may choose to participate in a clinical trial for a variety of reasons, such as having limited standard treatment options, hoping for better results, or wanting to contribute to the progress in treatment.

Before participating in a clinical trial, patients must go through a process called informed consent. This involves the doctor explaining all treatment options, the risks associated with the new treatment, what will be required of the participant, and the purpose of the clinical trial. By participating in clinical trials, patients are helping to advance medical knowledge and improve patient care while being carefully monitored for their safety.

Diversity and inclusion in clinical trials are crucial to ensuring that scientific advances benefit all communities, including those with different lived experiences, living conditions, and characteristics such as race and ethnicity, age, sex, and sexual orientation. Factors like biological sex, life experiences, unhealthy and health-promoting behaviors, environmental conditions, genetic variation, and underlying medical problems can influence the risk of developing a disease, experiencing long-term health outcomes, and responding to treatment.

Historically, clinical trials have not always recruited participants who represent the individuals most affected by a particular disease or condition. For instance, many clinical trials relied almost exclusively on White study participants, creating gaps in our understanding of diseases and conditions, preventive factors, and treatment effectiveness across populations. These gaps can impede the quality of health care decision making, counseling on ways to reduce risk, optimal treatment responses, and the development of more effective medications or interventions.

Clinicians and researchers should carefully consider the inclusion or exclusion criteria for their clinical trials to ensure the trial’s results are applicable to all groups. For example, a clinical trial excluding participants with high blood pressure or other comorbidities may end up excluding many people over 65 years old, who are more likely to have these conditions. The trial may then underrepresent certain groups in the study and make the results less applicable to groups who may benefit the most from the findings. Thus, diversity and inclusion in clinical trials are critical to advancing scientific knowledge and improving health outcomes for all communities.