timely web information: clinical trials

by Dave Harney

For anyone suffering from a chronic or debilitating illness, or even those plagued by minor illnesses, the hope for a cure or relief from pain and suffering can be enormous. Many look to new technologies or therapies for help. Some, who have tried all traditional therapies, look to clinical trials as a possible answer. Clinical trials are research studies conducted with human volunteers to answer specific health questions. Carefully conducted clinical trials are the fastest and safest way to find treatments that work and new ways to improve health.

It has often been difficult for patients to learn about opportunities to participate in these clinical trials. Doctors and patient advocacy groups can be valuable resources for patients in search of clinical trial information. And university medical centers such as University of Rochester’s Strong Hospital can provide information about clinical trials currently recruiting patients.

As a result of government action, however, it is now easier for consumers to investigate the potential of participating in a clinical trial. A website, www.clinicaltrials.gov, was initiated by the National Institutes of Health (NIH) to establish a registry of clinical trials for both federally and privately funded trials “of experimental treatments for serious or life-threatening diseases or conditions.” This website is meant to provide “patients, family members, health care professionals, and members of the public easy access to information on clinical trials for a wide range of diseases and conditions.”

Participants in clinical trials can play an active role in their own health care, and gain access to new research treatments before they are widely available. But are these new therapies, treatments, or other clinical trial methodologies better? There is significant risk an individual must assume when volunteering to be a clinical trial subject. There can also be downsides. Among them, the treatment may not be effective for the participant. Also, there may be unpleasant, serious, or even life-threatening side effects to treatment. According to the NIH, efforts are made to control risks to subjects, but some risk may be unavoidable because of the uncertainty inherent in research involving new medical products.

So volunteering for a clinical trial involves doing a lot of homework. There are many important questions to ask, some of which can be found on the clinicaltrials.gov website. It is also important that your personal physician be consulted before signing the “informed consent form.” This is a document you will sign that says you’re aware of the known risks involved in the trial.

The bottom line: Know and understand the different types of trials, which questions to ask, and your rights as a trial participant. Find out what risks there may be, and determine what level of risk you are willing to accept before you agree to enroll in a clinical trial for medical research.