Frequently Asked Questions

Clinical research helps doctors and scientists determine if an investigational drug or therapies are safe and/or effective for use in humans to potentially treat a condition, disease or disorder. Clinical studies often require a large number of volunteers to participate in a single study, sometimes thousands are needed to obtain reliable information.

One way to find information about clinical trials is by searching this website: www.clinicaltrials.gov. ClinicalTrials.gov is an interactive online database, managed by the National Library of Medicine. It provides information about both federally and privately supported clinical research. ClinicalTrials.gov is updated regularly and offers information on each trial’s purpose, who is eligible to participate, locations, and phone numbers to call for more information.

For those who are eligible, taking part in research studies offers several benefits:

• Getting actively involved in their own health care

• Having access to potentially new research treatments
• Having access to expert medical care for the condition being studied, since investigators are often specialists in the disease area being studied
• Helping others by contributing to medical research

It is important to test drugs and medical products in the people they are meant to help. It is also important to conduct research in a variety of people because different people may respond differently to treatments.

For each research study, researchers develop eligibility criteria, such as age, gender, previous treatment history, and other medical conditions. Not everyone who applies for a research study will be accepted. Volunteers may be excluded based on the eligibility criteria and/or the number of participants needed by the researchers.

Research studies can be sponsored by an organization such as a pharmaceutical company, a federal agency such as the Veterans Administration, or an individual, such as a physician or health care provider. The sponsor determines the location(s) of the trials, which are usually conducted at universities, medical centers, clinics, doctor’s offices, and/or at hospitals.

“Informed Consent” is a process of information exchange before an adult agrees to participate in research. Potential research participants will be asked to read and sign an informed consent document, but will also be given instructions, verbally and in writing, question/answer sessions and other reading materials to assure the potential study participants understanding and willingness to voluntarily enroll in the research.

Before you agree to volunteer for the study, the study doctor or staff is required to explain all the details of the study, which will include the risks and benefits, and address your questions. After all of your questions have been answered, and if you wish to participate, then you will sign a document called the informed consent form to ensure:

• You agree to volunteer
• You understand the study, including the study procedures, risks and potential side effects of the investigational drug
• You understand that you can leave the study at any time, for any reason

If you don’t understand what is expected of you or the document, you should continue to ask questions and talk with the study doctor, your family or others that you trust, until you feel you understand.