What are the benefits and risks of participating in a clinical trial?Benefits of participating include gaining access to new treatments before they are widely available, obtain expert medical care while in the trial, and help others by contributing to medical research.
Risks depending on the individual studies include unpleasant or serious side effects from experimental medication. Additional risks or downsides would be the chance of receiving a placebo or the experimental medication not working for all participants.
Who can participate in a clinical trial?All clinical trials have guidelines for who can participate. Potential participants are asked questions concerning their age, gender, symptoms, previous treatment of the condition, and other medical conditions or history. These questions determine if an individual could potentially be a good candidate for the clinical trial.
What safety precautions and steps are put in place for participants?Clinical research must follow all the same ethical and legal codes as medical practice (hospitals, private practice, or any other health organizations). In addition, each trial follows a protocol and carefully executed study plan. Every clinical trial that takes place is approved and monitored by an Institutional Review Board (IRB) to ensure the risks are as low as possible for participants. An IRB is a committee of physicians, statisticians, and community advocates to help ensure that studies are conducted in an ethical manner and protect the patients and their rights. The IRB initially approves the research as well as periodically as the study progresses.
Why are clinical trials necessary?Clinical trials are necessary to gain information about the efficacy and safety of drugs. The US Food and Drug Administration (FDA) specifies that new drugs need to be tested clinically and the data needs to be evaluated by the FDA to determine if the drug should be approved for commercial use.
What is a placebo?A placebo is a pill, liquid, or powder that has no active treatment in it. In some studies participants in the control group will receive a placebo instead of an active drug.