A clinical trial is a research project conducted with men, women or children to determine if an investigational drug, device or procedure is safe and effective.  Some other words that describe clinical research are study, protocol, survey or experiment.  Some different types of clinical trials are treatment trials, prevention trials, diagnostic trials, screening trials and quality of life trials.

 

When you participate in a clinical trial, you can play a more active role in your own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research.

 

All clinical trials have guidelines about who can participate.  Often, clinical-trial literature will list medical or other conditions that must be met in order to participate in a particular study.  In addition, Fremont-Rideout Cancer Center encourages diversity in its clinical-trial enrollments since the effects of diseases or conditions can vary with age, gender, race and ethnicity.  However, study criteria may exclude some from participation.

 

Research is conducted for many years before an investigational drug, device or procedure becomes available to clinical-trial participants.  Only the most promising new treatments make it to clinical trials.  Trials are conducted to confirm earlier findings that the drug, device or procedure is safe in humans.  During the trial, physicians and medical staff regularly and carefully monitor you to determine if the research is helpful and safe.  Negative effects are possible.  You will be fully informed of all known risks before you start.

 

A clinical trial may or may not help you personally, but it will give researchers information about treating health conditions in the future.  In most trials, you are assigned by chance to a control group or a study group.  The control group receives the currently approved medical treatment or a placebo.  Cancer clinical trials are an exception since the best standard of care is always provided to the control group.  The study group receives the investigational drug, device or procedure.  If it becomes clear during a clinical trial that one treatment is better than another, the trial is stopped so that all participants receive the beneficial treatment.

 

Each clinical trial has a well-documented plan, or protocol, about what you will need to do and what is expected.  You will be fully informed about the plan and everything that is known about the benefits and risks of the research.  You can ask any questions at any time.  If you decide to be in the trial, you will be asked to sign an “informed consent” form.

Clinical trials vary in length.  Some are as short as a few hours or as long as a few years.  You will be fully informed about how long you need to participate.  You may quit the study at any time without negative consequences.

 

Activities vary from one clinical trial to the next, but most require regular medical examinations.  Some trials involve taking either an approved or investigational drug, while others involve a procedure.  Sometimes you may be asked to record information about how you are doing at home.  You also may be asked to return for follow-up visits with the researcher so he or she can evaluate whether the research is producing the intended results and is safe.

 

Clinical trial costs are either billed to the participant’s insurance or paid by the sponsor of the study.  If you do not have insurance, the costs are often paid by the sponsor.  Cancer clinical trials are an exception.  California law requires most health insurers to cover the costs of cancer clinical trials. 

 

For more information contact the Fremont-Rideout Cancer Center at 530-749-4400.