Clinical Trials – Some Basic Information About Them

Clinical trials are the life blood of translational research (converting research into drugs and treatments). Without trials we wouldn’t know if a drug or treatment was safe or if it was little more than snake oil. Clinical trials are tightly controlled, designed to provide as much protection to its participants as possible, but by their very nature, they can pose increased risks to the participants.

Trials in the United States that involve human subjects follow very strict scientific and ethical guidelines before they can proceed. Each and every clinical trial must have a carefully designed plan (protocol) that describes exactly what will be done in the study and how it will be conducted.

All clinical trials that receive funding from the federal government or that evaluate a new drug or medical device that is subject to Food and Drug Administration (FDA) regulation first require an exhaustive review and approval process by an expert scientific panel known as an Institutional Review Board (IRB). These IRB panels include as mambers doctors, researchers, ethicists and patient advocates.

All clinical trial have strict eligibility requirements for participants which are spelled out in the trial’s protocol documents. Adherence to these requirements is always strict. In phase II and III trials, participants must be as similar as possible in terms of medical history, age range, overall health, type and stage of disease, and previous treatments. Meeting these eligibility requirements ensure that the clinical trial results truly reflect a difference between the treatment protocol and the control group.

Interested individuals who meet the enrollment criteria will first talk to the study coordinator who will explain the purpose and scope of the clinical trial. It is vital that you understand all of the risks and benefits the trial might hold out for you. There is always the possibility that new treatment that is not better than the standard treatment; you can experience unexpected, sometimes serious side effects from the trial; and you will probably be required to undergo more tests than you would typically need. On the flip side, benefits may include access to a treatment not otherwise available, access to high-quality care and monitoring, and learning after the trial is over that the treatment you received was more effective than the standard treatment.

Make sure you understand what financial costs, if any, you will be required to bear as a participant in the trial. There is a great variance in state laws and so not every insurance company will cover the costs associated with every clinical trial. Medicare covers some, but not all, routine care costs for clinical trials (such as doctor visits, hospital stays, lab tests, and x-rays). However, it does not cover costs incurred during cancer prevention trials, and it does not automatically provide for coverage to participants who enroll in clinical trials not funded by federal agencies.

Before beginning a trial you’ll be asked to sign an informed consent agreement. This is a form indicating that you’ve been given detailed information about the clinical trial and that you haven’t been forced to participate. Review this consent form completely and carefully with your doctor before signing it. Make sure that you completely understand everything in the document before signing. An informed consent form is not a contract and you may decide, without any penalty, to drop out of the trial at any time for any reason. Also, you may ask questions at any time during the trial.

Joel T Nowak MA, MSW

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