C. Everett Koop Initiates Online Clinical Trials Info Center for Patients

Former US surgeon general C. Everett Koop, MD, and Quintiles Transnational Corp. have launched an interactive, consumer Internet resource to enable interested individuals to sign up online for possible participation in clinical drug trials via the www.drkoop.com web site. This consumer service contains inter-active prescreening, enrollment, and tracking features designed to expand awareness and availability of clinical trials as a treatment option for consumers.

The Quintiles-drkoop.com Clinical Trials Information Center is a joint effort between drkoop.com, the Internet health care web site, and Quintiles, a provider of health care services to the pharmaceutical industry and clinical trials management organization.

Visiting the Web Site

This center gives drkoop.com’s 1.5 million monthly visitors access to information about clinical trials underway to test new investigational drugs in oncology, women’s health, and other therapeutic areas. It also features advanced online prescreening to help identify the best candidates for further evaluation by physicians conducting the trials, therefore increasing the efficiency and speed of the clinical trials process.

“Patient enrollment is the number one challenge in completing clinical trials on a timely basis,” said Dennis Gillings, PhD, chairman and chief executive officer of Quintiles Transnational Corp. “I believe the Quintiles-drkoop.com Clinical Trials Information Center will help meet this challenge while giving individuals expanded options to manage their health care.”

Clinical Trial Participants

Dr. Koop, chairman and founder of drkoop.com, said, “Today, only a small percentage of consumers are aware of clinical trials as a health care option, both from the standpoint of receiving a high level of care and in helping develop the latest products to treat debilitating or life-threatening diseases.”

The center, www.drkoop.com/hcr/trials, offers access to information about a number of ongoing studies, including summaries of the trials, inclusion and exclusion criteria, and contact information for the closest or most appropriate clinical sites. Neither the trial sponsors nor investigational drugs being studied are identified. The center also includes current information about the role of clinical trials in drug development, patients rights issues, and other educational materials.

Prescreening Potential Participants

Interactive questionnaires for prescreening are a part of the Clinical Trials Information Center. An individual’s responses are evaluated to determine whether he or she meets the trial’s basic criteria. If the criteria are met, the individual will be given information immediately about the most appropriate clinical site to contact. No information is stored or transferred without the individual’s consent during this process. The final decision to participate requires an evaluation and approval by the physician investigator and the patient’s informed consent. Unique to the Quintiles-drkoop.com center, interactive prescreening should increase the likelihood that patients referred to a site are qualified to participate in the trial.

Interested individuals who do not fit a trial’s inclusion criteria receive other useful information and can consent to have their prescreening information stored in a database and matched with appropriate trials in the future. To protect privacy, personally identifiable information is disclosed only to an investigator site, only with an individual’s permission, and only to help that person participate in a clinical trial. Individuals may withdraw their consent from participation in the program and require that their personal information be removed from the database at any time.