A clinical trial involves research using human volunteers (also called participants) that is intended to add to medical knowledge.
In a clinical trial, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or changes to participants' behavior, such as diet. Clinical trials may compare a new medical approach to a standard one that is already available, to a placebo that contains no active ingredients, or to no intervention. Some clinical trials compare interventions that are already available to each other. When a new product or approach is being studied, it is not usually known whether it will be helpful, harmful, or no different than available alternatives (including no intervention). The investigators try to determine the safety and efficacy of the intervention by measuring certain outcomes in the participants. For example, investigators may give a drug or treatment to participants who have high blood pressure to see whether their blood pressure decreases.
There are many reasons people volunteer for clinical trials. Healthy volunteers may hope to contribute to advancing science. Patients with an illness or disease participate with the hope the investigational treatment may benefit their condition or treatment outcome. While there are no guarantees that the investigational treatment will benefit you, each person who participates in a clinical trial contributes to scientific progress. Your participation helps researchers advance therapies that have the potential to improve and save lives.
Clinical trials that are well-designed and well-executed are the best approach for participants to:
There are also risks to clinical trials:
Clinical trials need to be approved before they start, and there are several layers of safeguards to protect the people who participate in them:
In addition to being monitored by an IRB, some clinical studies are also monitored by Data Monitoring Committees (also called Data Safety and Monitoring Boards).
Informed consent is the process of learning the key facts about a clinical trial before deciding whether or not to participate. It is also a continuing process throughout the study to provide information for participants. To help someone decide whether or not to participate, the doctors and nurses involved in the trial explain the details of the study. If the participant’s native language is not English, translation assistance can be provided. Then the research team provides an informed consent document that includes details about the study, such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits are explained in the informed consent document. The participant then decides whether or not to sign the document. Informed consent is not a contract, and the participant may withdraw from the trial at any time.