Patients

Clinical trials are research studies performed on people that are designed to evaluate a medical, surgical or behavioral intervention. They are the main way that researchers find out if a new treatment, like a new drug or diet or medical device (for example, a pacemaker) is safe and effective in people. Often a clinical trial is used to learn if a new treatment is more effective and/or has fewer harmful side effects than the standard treatment.

Clinical trials take place in all kinds of locations where people receive medical care across the United States. Academic hospitals, doctors’ offices, major hospitals, cancer centers, community hospitals, clinics, and stand-alone research centers. 

Clinical trials have a sponsor that manages the running of the trial. They are organizations or individuals, such as medical centers, drug and biotechnology companies, and even individual physicians can sponsor clinical trials. The National Cancer Institute, the National Institutes of Health and the Department of Defense can also sponsor and conduct clinical trials.

Clinical trials can take place in many locations, including hospitals, universities, doctors' offices, and community clinics. The location depends on who is conducting the study.

The length of a clinical study varies, depending on what is being studied. Participants are told how long the study will last before they enroll, and it should be listed in the informed consent form. 

Many different types of people take part in clinical trials. Some studies include healthy volunteers, while other studies include patient volunteers. Some studies include both healthy and patient volunteers.

Each study has its own rules about who can or cannot join. This is called “eligibility.” Your eligibility may be based on your age, gender, overall health, type and stage of a disease, treatment history, and other conditions. Not everyone is chosen to participate.

Research involving people is based on three values:

• Respect: All people should be valued and have the right to choose what treatment they get.
• Beneficence: Protect people from harm by giving the most benefit with limited risks
• Justice: Try to make sure that all people share the benefits and burdens equally.

The Office of Human Research Protections (OHRP) is the government’s main protector of people’s safety in clinical trials. The OHRP makes sure that the rules of informed consent, IRBs, and participation of people with special needs are followed. OHRP can stop clinical trials when problems are found.

Informed consent in a clinical trial is the process of giving participants all the facts about a study. This happens before they agree to voluntarily take part in the study and over the course of the trial. 

The informed consent form, or ICF, should contain the following information. An explanation of the trial’s purpose, clinical procedures being performed, how long you will participate, and the investigational treatments or procedures. The ICF should have an explanation of any side effects or foreseeable risks you may experience in the study. A description of any possible benefits you may get from the treatments. The procedures are in place to keep your information private and secure.  Information about any payment you may receive and whether the research team will be responsible for medical treatments if injury occurs. A list of contacts to answer any questions you have during the trial. A statement confirming that your participation is voluntary and that you can discontinue your participation at any time without penalty.

An Institutional Review Board, or IRB, is an appropriately created group that has been officially selected to review and monitor medical research involving human participants. In accordance with FDA regulations. The IRB has the authority to approve, require changes in (to secure approval), or disapprove research. The IRB also monitors the studies on a yearly basis to evaluate the administration of the study. This group review serves a key role in the protection of the rights and welfare of human research participants.

The U.S. Food and Drug Administration oversees clinical trials to ensure they are designed, conducted, analyzed, and reported according to federal law and good clinical practice (GCP) regulations.

People take part 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 take part to help others, but also to possibly receive the newest treatment and to have additional care and attention from the clinical trial staff. Treatments might be new drugs or new combinations of drugs, new surgical procedures or devices, or new ways to use existing treatments.

What is the purpose of the trial? 
How long will I be in the trial?
What kinds of tests and treatments are involved? 
What are the possible side effects or risks of the new treatment?
Are there any benefits? 
How do the possible risks and benefits of this trial compare to those of the standard treatment?
Will my health information be kept private?
Which costs do I have to pay if I take part in the trial?

You can ask your doctor, nurse, or healthcare professional about clinical trials or other healthcare studies that may be right for you. Both healthy volunteers and participants with specific health conditions are needed to help answer important questions affecting the health of everyone.