Frequently Asked Questions (FAQs)

What is a Clinical Trial?

New drugs and medical devices are thoroughly tested in a laboratory setting before people may take them. If the initial laboratory results are promising, the drug is then tested in groups of people. When people as part of a study take new drugs, it is call a clinical trial.

The results of a clinical trial are very important. They allow researchers to determine if a drug works and if it is safe when people take it. Researchers are able to monitor side effects, negative reactions, and the successful treatment of illnesses. Drugs may also be suited for new indications.

Research is not only for medications. Clinical trials may also be conducted to study new surgical, diagnostic, or treatment procedures in a “real world” setting.

Why do people participate in clinical trials?

There are several reasons why people volunteer for clinical trials but for most, it is the possibility to help themselves and to help others who may benefit from developing a new medication or treatment.

In a spring 2000 Harris Poll of cancer clinical trial participants, 76 percent of the respondents said they participated because they believed that the trial offered the best quality of care for their disease. Helping other people and receiving more and better attention for their own specific disease were other reasons cited.

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What are the risks involved?

Participating in a clinical trial is not without risk. Some of the risks are:

• There may be unpleasant, serious or even life-threatening side effects of the treatment.
• The treatment may not be effective for the participant.
• The protocol may require more of a participant’s time and attention than would a non-protocol treatment, including trips to the study site, more treatments, hospital stays or complex dosage requirements.

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What are the benefits of participating in clinical trials?

Clinical trials that are well-designed and well-executed allow eligible participants to:

• Play an active role in their own healthcare.
• Gain access to a new research treatment before it is widely available.
• Obtain expert medical care at leading healthcare facilities during the trial.
• Help others by contributing to medical research.

Only after becoming fully informed and weighing the risks and benefits should someone consent to participating in a clinical trial.

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What if I join a clinical trial and later change my mind? What are my rights as a patient?

The people involved in your care must treat you with consideration and respect. Your have the right to:

• withdraw from a clinical trial at any time without giving a reason.
• be told all the important details about your care
• ask questions and have them answered
• say no to any test, procedure or medication
• go to another health care provider to get more information
• know the names of anyone you talk with
• read your medical records with your health care provider
• make you own decisions about your healthcare
• know that your medical records will be kept confidential

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What is Informed Consent?

You may already have experience with signing consent forms for other kinds of medical procedures, such as surgery, or for cancer treatments such as radiation or chemotherapy. However, informed consent for a clinical trial involves much more than just reading and signing a piece of paper. Rather, it involves two essential parts: a document and a process.

The informed consent document provides a summary of the clinical trial (including its purpose, the treatment procedures and schedule, potential risks and benefits, alternatives to participation, etc.) and explains your rights as a participant. It is designed to begin the informed consent process, which consists of conversations between you and the research team. If you then decide to enter the trial, you give your official consent by signing the document. You can keep a copy and use it as an information resource throughout the course of the trial.

The informed consent process provides you with ongoing explanations that will help you make educated decisions about whether to begin or continue participating in a trial. Researchers and health professionals know that a written document alone may not ensure that you fully understand what participation means. Therefore, before you make your decision, the research team will discuss with you the trial’s purpose, procedures, risks and potential benefits, and your rights as a participant. If you decide to participate, the team will continue to update you on any new information that may affect your situation. Before, during, and even after the trial, you will have the opportunity to ask questions and raise concerns. Informed consent is an ongoing, interactive process, rather than a one-time information session.

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For more information:

• http://www.centerwatch.com/patient/backgrnd.html
• http://www.clinicaltrials.gov/ct/info/whatis
• http://www.acrpnet.org/resources/trial/
• http://www.fda.gov/oashi/clinicaltrials/clintrialdoc.html
• http://www.hhs.gov/ohrp/