Clinical Studies and You
You may have heard of clinical studies, but you might not know much about them. Each medicine doctors give their patients must first be approved by a regulatory agency, such as the U.S. Food and Drug Administration (FDA) and similar agencies in other countries. Before this can happen, we need real-world evidence that a medicine is safe and that it is effective in the populations with disease. Sponsors (pharma and biotech companies) run clinical studies to gather the evidence and submit it to regulatory agencies who review the evidence and approve the medicine for patients, if it is safe and effective.
To collect the evidence, clinical studies test new medicines being developed in people of all ages, races, and ethnicities. Studies may include people from around the world. Some people who take part in studies are healthy volunteers; while others have a specific disease or health condition for which the medicine is being evaluated.
Clinical studies study the safety and effectiveness of:
- New medicines
- Combinations of medicines
- New ways to use medicines that have previously been approved
- Vaccines
- Medical and surgical devices or procedures
Clinical studies are conducted in 4 phases – Phase 1 to 4. Sponsors move the medicine through the clinical development program, if it meets the criteria established for each phase. In all phases, the top priority is to protect the patients who take part in the study. To that end, studies include safeguards such as the following:
- Patients have the right to choose to participate in a clinical study by providing their consent at the start. Consent can be withdrawn by the patient at any time during the clinical study, for any reason and with no penalty.
- Study teams are given a written study plan that tells them how the study will be conducted and how safety measures will be implemented.
- The study plan must follow strict medical and ethical standards at all times.
- A study cannot begin until an independent Ethics Committee and/or Institutional Review Board approves the plan.
- Independent safety boards may review data at key points to see if a study should continue or if changes should be made to the plan.
Even with these safeguards in place, studies come with some risks; which is true of most medical treatments and procedures. Your health may improve, but it could also remain the same or get worse. You could have side effects from the therapy being studied or from procedures that are part of the study. For the safety of patients, studies include close monitoring by an expert healthcare team. The team will talk with each person in a study about the risks and answer any questions they may have. They will also take steps to prevent and treat potential side effects that may occur. Open and honest communication with the healthcare team is a key part of being in any study.
If you’re interested in clinical studies, you can ask your healthcare provider about studies that might be right for you.
For additional information about clinical studies, download this helpful brochure: