A Step-by-Step Guide to Clinical Trials

A clinical trial is a biomedical or health-related research study that uses human participants to investigate a treatment, drug, medical device or behavioral intervention. Clinical trials can be either intervention- or observation-based, depending on whether participants receive a treatment or are monitored only for health outcomes. Clinical trials are undertaken by medical researchers, pharmaceutical corporations, and government institutions, such as the National Cancer Institute and the Food and Drug Administration. Although there are many types of clinical trials, they all consist of certain elements and follow a determined protocol.

Instructions

• 1

  Understand the reasons for participation. Clinical trials not only benefit medical investigators, but offer potential gains to research subjects as well. Participants in a clinical trial may be able to access new treatments before they become widely available, and can help others by contributing to medical knowledge.

• 2

  Understand the research process. In a clinical trial, participants work closely with the research team, which generally consists of doctors, nurses and other health-care professionals. The team will assess eligibility for participation and explain the purpose of the study, including the risks and benefits entailed, and describe the role of the participant. Some studies require tests or frequent doctors visits. In all cases, the research team will closely monitor the participant throughout the duration of the study, and generally will follow up with the participant after the trial is concluded.

• 3

  Provide informed consent. Informed consent is a crucial part of a clinical trial, in which the participant learns key facts about the study and decides whether or not to volunteer as a subject. Informed consent is an ethical agreement between the research team and the research subjects, and is reinforced throughout the study period. Informed consent in not a binding contract, and participants can chose to withdraw at any time without penalty.

• 4

  Learn the risks and benefits. The risks and benefits of a clinical trial will vary depending on the nature of the research. Broadly, benefits may include the ability to access new experimental treatments and to receive expert care, and some studies might offer financial compensation. Some clinical trials pose serious risks to participants and in rare instances can be life-threatening. Experimental treatments can have adverse side effects, and not all are effective for all patients. Additionally, participation can be time-consuming and possibly interfere with daily life.

• 5

  Understand protections. The protocol for clinical trials include extensive regulations for protecting the health and rights of research subjects. Clinical trials follow specific legal and ethical codes to minimize harms and heighten benefits to the participants, and to fully protect and uphold confidentiality. During or after a clinical trial, researchers publish their findings, and to maintain confidentiality, these publications include no identifying information about the participants.

• 6

  Find a trial. If you are interested in participating in a clinical trial, the National Institutes of Health maintains a comprehensive database of research opportunities (see resource 1). Additionally, for clinical trial information pertaining specifically to children, the National Heart, Lung, and Blood Institute has created a detailed and accessible website for parents and caregivers (see resource 2).