- A participant may not receive any active medicines. Patients with hard-to-treat illnesses may view clinical trials as an option of last resort, potentially offering cures that aren’t otherwise available on the market. For patients who hope to receive benefits from an experimental medicine, it can be disappointing to later learn that instead of being given the new medicine, the patient was instead given a placebo as part of the experimental control group. Because a control group is a necessary part of the scientific process, patients should know that this is a risk of being involved in any clinical trial.
- The product may turn out to be dangerous. The object of a clinical trial is to answer specific scientific questions about the tested product, such as whether it is effective in reducing certain indicators related to a specific disease. Researchers are required by law to disclose all known risks associated with a given product as part of a participant giving informed consent to participate. But researchers may not know all the potential risks of a new product. Some individuals may react badly to the product, even facing long-term illness or death as a consequence of the product itself or its interaction with other chemicals in the patient’s body.
- Researcher negligence. The pressure on businesses to reach favorable outcomes in trials is significant. Researchers may make serious mistakes or may even commit acts of fraud in order to speed up or alter the results of a study. In some cases, a researcher’s bad behavior could lead to a patient’s injury.
Clinical trials are a fundamental part of the development of new medicines and other products, like medical devices. Before a product is tested in a clinical trial in the United States it is required to undergo extensive safety testing to prove that it doesn’t pose a risk of toxicity or other hazards to patients in the trial. Safety standards for clinical trials are determined and enforced by the U.S. Food and Drug Administration. One hopes that the standards protect participants from being placed at an undue risk of harm, but problems can still happen. There are several sources of risk related to participating in a clinical trial: