What is a clinical research trial?

A clinical research trial is a scientific investigation (trial or study) of a research medication or treatment to find out how it works in people. Through clinical trials, doctors help find possible new ways to prevent, detect, diagnose, control, and treat illnesses. Before a new medication can be approved for use by the public, it must be tested thoroughly according to strict guidelines established by the U.S. Food and Drug Administration (FDA). Participation in clinical trials is completely voluntary and all information provided by a participant is kept strictly confidential and used only for the purposes of conducting the study, as required by law.

What happens during a clinical trial?

Participation in a clinical trial means you will work with a research team in a clinical office setting. Team members include doctors, nurses, study coordinators, and other health care professionals. As a qualified volunteer for a study you will receive all medical visits and procedures directly related to your participation in the study at no cost. This can include: physical exams, doctor visits, study medications, laboratory tests, EKGs, etc.

I am healthy. Can I participate?

Before new medical therapies can help patients, they must first be tested with healthy volunteers in Phase I clinical trials. A Phase I trial aims to find out any safety issues and determine appropriate dosage levels. Researchers need to see how the body tolerates the new substance and record any side effects that may occur as dosage levels are increased.

What are the benefits of participating in a clinical trial?

Most of our current information on medicines and diseases has been obtained from research. New drugs are being developed daily and may offer advantages over existing ones. Still, being involved in a research study sometimes makes us uneasy. It helps if we remember the many research successes over the past few decades. For example, vaccines and antibiotics have been developed to eradicate many previously common and deadly diseases such as smallpox, polio, diphtheria, tetanus, and childhood leukemia. It should be remembered that there are no guaranteed benefits to your participation in a clinical trial. Any potential benefits to you and society should be discussed with you, by your doctor, prior to your entry into a study.

Who participates in clinical research and how are they selected?

Lots of different people, like you and I, participate in clinical research. Every study identifies some specific characteristics that the participants should have in order to participate. These characteristics are called eligibility criteria. Some of the characteristics are things like age, general health, a diagnosis of a particular disease, certain symptoms, etc.

Why can’t I know which drug I use?

A key element in any research trials is to have accurate results. The study may either compare a research drug to standard therapy or a placebo (an inactive substance). The study coordinator, physician, and you may have no idea whether you are receiving the actual drug or a placebo. This ensures that the study trial has been unbiased in the results and will show how the new medication does, or does not, work.

How am I protected during the research clinical trial?

Patient safety is the number one priority of the FDA, the pharmaceutical companies, the Penn State Clinical Trials Office, and the Penn State Human Subjects Protection Office. Before participating in a study, you must agree to, and sign, an Informed Consent which gives detailed information about the study, procedures, and medications including the risks. Experienced physicians who have been thoroughly trained and designated as Principal Investigators monitor you throughout the study. An Institutional Review Board (IRB) must review and approve all studies before you are asked to participate in the study. The IRB is made up of scientific and non-scientific members, clergy, administrators, and members of the public. IRB approval of all research is required by U.S. Food and Drug Administration (FDA) to ensure protection of the rights and welfare of patients who are enrolled in clinical trials.

How do I know my personal information will be kept confidential?

Federal laws mandate that your personal information be kept strictly confidential and that you be informed of all parties who will view that information. These parties typically include your doctor, nurse, and/or study coordinator, a representative of the sponsoring organization, and occasionally a representative of the FDA. In most cases, this viewed information will have personal identifiers replaced by your initials and study number. The specifics should be discussed with you, in detail, prior to your entry into a study.

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