Clinical trials are part of clinical research and at the heart of all medical advances. Clinical trials look at new ways to prevent, detect, or treat disease. People participate in clinical trials for a variety of reasons. Healthy volunteers say they participate to help others and to contribute to moving science forward. Participants with an illness or disease also participate to help others, but also to possibly receive the newest treatment and to have the additional care and attention from the clinical trial staff.
In most studies, health insurance is not required for participation and all study related care is provided at no cost.
Clinical trials that are well-designed and well-executed are the best approach for eligible participants to play an active role in their own health care, gain access to new research treatments before they are widely available, obtain expert medical care at leading health care facilities during the trial, and help others by contributing to medical research. Clinical trials are not just for new drugs and treatments, but also for perfecting what is already available on the market.
There are always certain risks or side effects to clinical trials. The experimental treatment may not be effective for the participant and could also have negative or adverse effects that may include headache, nausea, skin irritation, or other physical problems. Experimental treatments must be evaluated for both immediate and long-term side effects.
Based on many years of experience and learning, congress has passed laws to protect study participants. Today, every clinical investigator is required to monitor and make sure that every participant is safe. Researchers are required to follow strict rules to make sure that participants are safe. These rules are enforced by the Federal Government. Each clinical trial also follows a careful study plan or protocol that describes what the researchers will do. The principal investigator, or head researcher, is responsible for making sure that the protocol is followed. When the drug is ready to graduate to human clinical trials, the trial sponsor must submit an Investigational New Drug application to the FDA and the study protocol must be submitted to an Institutional Review Board whose primary role is to ensure participant safety.
In clinical trials that compare a new product or therapy with another that already exists, researchers try to determine if the new one is as good, or better than, the existing one. In some studies, you may be assigned to receive a placebo (an inactive product that resembles the test product, but without its treatment value).
Comparing a new product with a placebo can be the fastest and most reliable way to show the new product’s effectiveness. However, placebos are not used if you would be put at risk — particularly in the study of treatments for serious illnesses — by not having effective therapy. You will be told if placebos are used in the study before entering a trial.
Only through clinical research can we gain insights and answers about the safety and effectiveness of treatments and procedures. Groundbreaking scientific advances in the present and the past were possible only because of participation of volunteers, both healthy and those with an illness, in clinical research. Clinical research requires complex and rigorous testing in collaboration with communities that are affected by the disease.