The following press release provides insight on industry trends and behaviors impacting all players involved in clinical research as analyzed and reported by CenterWatch.

CenterWatch Survey Among Study Volunteers Finds Strengths and Weaknesses in the Informed Consent Process

BOSTON - May 21, 2002 - A new CenterWatch survey finds that, following their review of the informed consent form, the majority of clinical trial volunteers understand the logistics of their participation as well as their right to withdraw from a clinical trial at any time. However, the results also suggest that many trial volunteers give their consent to participate without input from others and that they do not fully understand the risks involved in their participation. Survey findings and detailed interviews with patients and research professionals are presented in the May issue of the CenterWatch monthly newsletter.

In January and February of 2002, CenterWatch conducted an online survey among nearly 1,600 study volunteers who had completed a phase I through III clinical trial within the past six months. As part of their participation, respondents reviewed the informed consent form with a physician researcher or a study coordinator. The survey evaluated a number of process areas including volunteer comprehension of clinical trial expectations, participation risk and the ways that volunteers go about giving their consent. Several notable findings:

• 89% of volunteers understood that they could terminate their participation at any time, and a similarly high percentage understood the duration and number of participatory visits required.
• 30% of volunteers did not understand that their study could carry additional risks and discomforts.
• 18% of respondents decided to give their consent without any input from their personal physician, nurse, family member or trusted advocate.
• 70% of volunteers stated that, at the outset of the informed consent process, they didn't know what questions to ask.

CenterWatch CEO Kenneth Getz commented, "These results offer insight into when is the best time for volunteers to learn about whether clinical trials are a viable treatment option. Reviewing and signing an informed consent form is an important activity. But this mandatory process is not where a volunteer's decision to consent should begin. Ultimately, study volunteers have to take the responsibility of educating themselves prior to even inquiring about participating in a clinical study. And the professional community can play a key role here."

Traditionally, there has been a void in terms of where participants and professionals can go for comprehensive information about clinical trials. To address this void, CenterWatch recently launched a new guide for research and health professionals and patients looking for balanced facts and information about the clinical trial process, the risks and benefits, a volunteer's rights and recourse, and how to find and evaluate clinical trials. The guide, entitled, Informed Consent, is based on data gathered by CenterWatch over a four-year period, extensive literature review, expert commentary and interviews with research and regulatory professionals, patient advocates, volunteers and health consumers. The new guide includes a collection of practical resources including contact information for companies conducting clinical trials and a list of several hundred questions for potential volunteers to ask.

Individuals interested in ordering copies of the May issue of CenterWatch Monthly, and copies of the new Informed Consent: A Guide to the Risks and Benefits of Volunteering for Clinical Trials, should visit www.centerwatch.com or call 1-800-765-9647.

About CenterWatch

CenterWatch is a Boston-based information services company that focuses on the clinical trials industry. CenterWatch offers a variety of publications and services for clinical research and general health professionals, patients and health consumers. Along with disease specific reports and profiles of centers that conduct clinical trials, CenterWatch publishes a variety of searchable databases online including directories of several thousand drugs in clinical trials, drugs recently approved by the FDA, and clinical trial results. In addition, the CenterWatch web site lists more than 42,000 ongoing clinical trials seeking volunteers. An estimated eight million people will visit the CenterWatch web site at www.centerwatch.com to view these trial listings. CenterWatch is a subsidiary of Thomson Healthcare, publishers of the Physicians Desk Reference ®.

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