Clinical trials explore whether a medical strategy, treatment or device is safe and effective for human use. Studies may also show which medical approaches work best for certain illnesses or groups of people. Many treatments and medications used today were made possible by past clinical trials and the patients who participated in them.
Taking part in a clinical trial can have many benefits. For example, you may have access to new treatments long before they are widely available. Even if you don’t directly benefit from the trial results, critical learnings can add to scientific knowledge and improve health care in the future. Many people volunteer to participate because they want to help others. Clinical trials and trial participants are essential to advancing medical care.
Given the purpose and nature of clinical trials, there can be some risks and downsides. For example, the study may find that new strategies and treatments are not more effective than current care standards. Or a new approach may benefit some but not all participants in the study. There is also a possibility of unexpected side effects.
The protocol of each clinical trial details the number of participants, patient eligibility, tests or procedures involved and the type and frequency of data to be collected. Treatment plan and safety procedures are also outlined in the protocol.
If you are considering participation, you will be thoroughly informed about the nature of the trial, how it will work and any risks and potential benefits. Participation is always voluntary, and you may withdraw at any time for personal or medical reasons. If you are currently enrolled in a trial and would like to stop, talk to the research team about next steps.
Clinical trials are performed for many reasons, including evaluation of new ways to prevent, detect and diagnose disease and/or the effectiveness of current or new treatments. They may also explore ways to improve patient comfort and quality of life and decrease the severity of side effects caused by disease or treatment. In addition, a trial may strive to determine effects of a patient’s genetic makeup on detection, diagnosis or response to treatment, or to study the role of genetics in disease development among certain populations.
Clinical trials are sponsored by government agencies such as the National Institutes of Health (NIH) as well as pharmaceutical companies, individual doctors, healthcare centers and organizations that develop medical devices or equipment. If the trial is being conducted to test the safety of a product such as a medication, it is overseen by the U.S. Food and Drug Administration (FDA). Compliance with strict standards is required at all times.
Each study is managed by a research team that may include a doctor (also known as the principal investigator (PI)), pharmacist, nurse, coordinator and other qualified research staff members who collaborate to monitor the health of all participants.
Patient safety is our number one priority. An Institutional Review Board (IRB) must review and approve all clinical trials conducted or supported by U.S. federal government agencies or trials evaluating new drugs or medical devices subject to regulation by the U.S. Food and Drug Administration (FDA). The IRB reviews all aspects of a clinical trial to ensure protection of the rights, safety and wellbeing of trial participants. Some trials also use an independent Data and Safety Monitoring Board (DSMB) to monitor safety and progress.
The length of a clinical study varies, depending on what is being studied. Before enrollment, you are informed about how long it will last.
Costs of care for clinical trial participants fall into two general categories. Routine care costs – those associated with treating a disease or condition – are usually covered by health insurance, but coverage varies by state and type of health plan. The second category is research costs – those associated with conducting the clinical trial. Costs of treatments, tests and procedures for each trial may be handled differently. Many trial sponsors provide the study treatments or procedures at no cost to participants and may also cover the cost of tests for data collection. It is important to talk with the research team for a clear understanding of what costs are and are not covered by insurance or the trial sponsor.
An investigational medical device and related services will fall into one of two categories defined by the U.S. Centers for Medicare & Medicaid Services. Category A includes experimental or investigational devices for which there is no Medicare coverage. Category B includes devices that are non-experimental and are eligible for Medicare coverage. Payment for covered Category B devices and related services will be based on, and may not exceed, the amount that would have been paid for an FDA-approved device and related care serving the same medical purpose.
Researchers will carefully examine all collected study information before making decisions about the meaning of findings and about further testing. For some trials, researchers will decide to move on to the next phase or to stop testing the treatment or device because it was found to be ineffective or unsafe. Results from clinical trials are often published in peer-reviewed scientific journals after expert review, ensuring sound analysis and conclusions. When a new approach is proven safe and effective in a clinical trial, it may become the standard of medical care for the condition being studied.