WEDNESDAY, OCTOBER 8, 1997
"Clinical Trials: Overcoming Barriers to Information and Access"

Overview

Dr. Tripathy told the group that clinical trials are becoming more and more important. At UCSF, one useful trial involves using MRI to define the extent of ductal carcinoma and the effect of treatment. Trials must be designed towork quickly and well. Currently it takes five years to find out if a new treatment works, and seven years to find out that it doesn't. There is no shortage of new drugs, but a serious shortage of subjects. Most research is done in high volume clinics by doctors who recruit their own patients and advertise in newspapers. Pharmaceutical companies ffocus on getting a product to market; they have enormous budgets but leave some questions (i.e., quality of life) unanswered. Dr. Tripathy is starting research on alternative medicine. No money is available for this from pharmaceutical companies.

Two main areas were discussed:
1) Getting information out to patients, how to prioritize trials and who is eligible;
2) Identifying and overcoming barriers to trials.

Information

At present, the only available list of clinical trials is the PDQ (Physician Data Query), listing studies that have been reviewed by the NCI. Quality measurements are sometimes minimal and the research not always good. Deborah Collyar and her staff have spent the past 3-1/2 years compiling a comprehensive guide to brest cancer trials in northern California. It is known as CTIP, Clinical Trials Information Project. Oriented to patients rather than physicians, and written in plain English, CTIP contains 1 page summaries condensed from 20- to 65- page research protocols. IRB approval is the criterion for inclusion. The CTIP guide is organized by cancer stage. It is part of a pilot project in northern California. It will be printed as soon as printing costs ($10,000-$15,000) are raised, and will be distributed to primary physicians. Dr. Tripathy noted that educating this group is important. At most, primary physicians see 10 patients with breast cancer per year. They need an incentive to look at clinical trials; many are fearful of losing patients. CTIP plans a website by January, 1998.

Barriers to Clinical Trials

• Most patients only hear about them after they're in treatment, when it's too late to join.

• Patients with Stage IV disease can't get into a trial. This can be changed according to Dr. Tripathy.

• In Phase 1 trials (first time testing on humans), patients get such a low dose of the drug or treatment that it doesn't make much difference.

• Cost can be prohibitive. One woman at the meeting said she can't afford the $300+ cost for a genetic testing trial on top of the cost of treatment.

• Written descriptions of research are better than oral. Patients need time to process information on their own.

• Certain ethnic or cultural groups are fearful of all trials. Working with people in these communities ahead of time could overcome these fears.

Prioritize trials, develop relationships with people running them. Dr. Tripathy wants to make access easier for his patients. Plans for a workable system are in the works, so that patients can get information on clinical trials, filter that information and prioritize.

In other business, Dr. Tripathy is forming a seminar on Alternative Medicine. Plans will be discussed in this group.