A Clinical Trials Primer

Basically a clinical trial is a scientific research involving people, that studies the effects of a new medication, therapy or device to determine if it is safe and effective.

In the United States, clinical trials are monitored by the Food and Drug Administration.

The Phases of a Clinical Trial:

Phase I evaluates dosage parameters.

Phase II continues to evaluate safety and begins to study efficacy.

Phase III compares the new drug with standards of care or if there are none, a placebo.

Phase IV is used if the drug normally used as a standard is to be used for another condition or if the formulation is changed. This phase may also be used for extended studies on drug side effects.

Cancer clinical trials may involve studies of prevention of cancer or the treatment of cancer.

Per the National Cancer Institute Fact Sheet, 1/10/2000:

There are two types of prevention clinical trials that study ways of reducing the risk of getting cancer:

• Action studies (doing something) – These focus on finding out whether actions people take, such as exercising more or quitting smoking, can prevent cancer.
• Agent studies (taking something) – These studies examine whether taking certain medicines, vitamins or food supplements (or a combination) can prevent cancer.

Why Participate in a Clinical Trial?

People participate in clinical trials for many reasons including the opportunity to try new cutting edge therapies under the care of leading researchers and health care providers, and for the opportunity to contribute to research to help themselves and others.

Clinical trials do have side effects including the possible negative effect of the therapies and/or no effects at all and they can be more time consuming than originally anticipated.

If you are considering participating in a clinical trial not only is it important to explore all facets of the trials through informed consent, but it is important to determine the cost and funding of a clinical trial and how your insurance coverage or Medicare comes into play. Get answers ahead of time.

In depth resources on clinical trials and registries for clinical trials:

ClinicalTrials.gov not only lists registries of current clinical trials in the U.S and other countries but breaks them down according to condition, drug, sponsor and location.

World Health Organization International Clinical Trials Registry Platform. “The mission of the WHO Registry Platform is to ensure that a complete view of research is accessible to all those involved in health care decision making.”

National Cancer Institute Information on Clinical Trials, including a detailed fact sheet called Clinical Trials and Insurance Coverage: A Resource Guide.

CRISP, Computer Retrieval of Information on Scientific Projects. “A biomedical database system containing information on research projects and programs supported by the Dept. of Health and Human Services.”

Center Watch: Clinical Trials Listing Service. This site provides a notification services for new clinical trials.

The American Cancer Society, Clinical Trials Matching Service. “… a free, confidential program that helps patients, their families, and health care workers find cancer clinical trials most appropriate to a patient’s medical and personal situation.”

Clinical Trials in the News:

StreetInsider.com, April 2, 2008: EntreMed Commences Continuous Dosing Clinical Trial For MKC-1. EntreMed ” today announced that it has commenced a Phase 1, open-label, continuous dosing study with its oral cell cycle inhibitor, MKC-1, in patients with advanced or metastatic solid tumors…”

U.S. New& World Report, April 1, 2008. Report Claims Clinical Trials Miss Many Populations. “A new analysis of the American clinical trial process suggests that the system for testing new drugs has routinely excluded or under-represented women, older people, minorities, disabled individuals and rural populations for decades.”

Wall Street Journal, April 1, 2008: Pfizer ends Clinical Trial of Melanoma Treatment. “Pfizer Inc. has ended a Phase III clinical trial of tremelimumab in patients with advanced melanoma after a review of interim data showed that the drug was not better than standard chemotherapy.”