A clinical trial is a part of the process of testing a treatment under scientific investigation on human subjects. This type of research is a very important resource for some rare cancer patients, and has proven to be a life-saver to others. There are three phases to a human clinical trial.
Most Phase I clinical trials involve a drug that has not been tested on humans, but has proven itself in laboratory testing. This means that the drug may or may not work as designed in the laboratory. Any human toxicities and side effects that may result are unknown until the test subjects experience them. Because of these situations, phase I clinical trials participants are few in number and usually patients who have no other reasonable options. This phase of the trial process allows researchers to determine the treatment's safe dosage.
During this phase the proposed treatment is used on a larger number of patients, allowing investigators to see the less common side effects. Careful monitoring is done on each patient to check for any adverse reactions and the response level to the treatment. Less than 5% of proposed treatments reach this phase of testing.
This phase allows researchers to compare the effectiveness of the treatment. Some participants are given the proposed treatment, others are given the current standard treatment (or no treatment if none is currently available). A much larger number of patients are allowed in this phase, but the guidelines for admission are more stringent. Participants usually have a specific cancer, at a specific stage, and have not undergone, or are not undergoing, any other treatments for their cancer. If during the trial period, the drug is found to be more effective than standard treatments used currently; the trial period is ended and all participants are given the trial treatment.
Payment for hospital treatment and laboratory monitoring that may be required for participation in the trial may, or may not, be paid for by the sponsors of the trial. If this is the case, check to see if your insurance company will pay for these experimental treatment costs.
There is a review procedure in place for all clinical trials that looks at all aspects of the trial. This procedure is done by a diversified team of clinicians and laypeople (other than the trial researchers), called an IRB (Institutional Review Board).
Participation in a clinical trial does not necessarily mean that you will have to travel long distances. The CCOP (Community Clinical Oncology Program) links local physicians and medical facilities with trial researchers. This enables a larger number of patients to participate in trials.
All participants of a clinical trial must sign an informed consent form. This is a detailed document that explains the trial, the benefits expected, other options available, and how you will be compensated if your participation in the trial results in adverse effects. This document should be thoroughly reviewed by all participants prior to signing.
Participation in a clinical trial should not be taken lightly. It is a serious, sometimes life changing, decision to make. You may want to illicit the advice of several clinicians and confidants prior to participation. But keep in mind that if the trial is successful, you will have first access to a new treatment for your cancer.
Rare Cancer Clinical Trials - pages that have a list of clinical trials for all rare cancer types.
NCI - comprehensive pages on trials including a trial search option (click on column headings).
Cancer Research Foundation - what issues to consider prior to participating.
Center Watch - publications about the Clinical Trials Industry
NIH Clinical Trials - National Institute of Health's introduction to clinical trials.
Centerwatch - allows you to search for private industry trials as well as government sponsored trials.
Emerging Med - a trial matching service that is free and confidential.