Ultimately, trial enrollment will always require extensive human interaction between all interested parties. Tools that can facilitate the magic that occurs when new methods of treatment get to market can change lives. Key to a successful clinical trial is timely enrollment and retention of properly qualified subjects by properly qualified clinical investigators. What would at first glance appear to be a simple, straightforward task is complicated by the realities of operating clinical research within the overall healthcare sphere. This much is clear: 1. Trial design and feasibility must include enrollment issues. 2. Effective enrollment must be investigator focused. 3. The ideal candidates for participation in clinical trials come from within the investigator’s own patient population pools. 4. More efficient means of patient enrollment are needed to serve the rapidly increasing number of clinical trials. 5. More investigators are needed to conduct clinical trials. 6. Technology can play an important and cost-effective part in the enrollment process. Historically, patient enrollment was linked directly to investigator enrollment. The theory that hiring enough investigators who claimed to have the right patients would ultimately produce rapid enrollment has not been borne out in the market, with as many as 85% of trials considered “late.” A more in-depth trial design must incorporate the reality that, particularly in a practice-based setting, the environment is competitive with regard to the investigator’s attention to any particular trial. For this reason, a true feasibility study should include investigator credentials, an analysis of his or her business practices, as well as empirical confirmation that patient populations exist in the practice. Easy Enrollment Leads to Success Once sufficient patient populations have been confirmed in the feasibility stage, the most successful trials are the ones that make it easiest for investigators to enroll and retain patients. Providing the clinical-research site with tools that maximize a site’s investment in personnel and training will produce the best results. Historically, support of patient enrollment has been provided using a wide range of products and services designed to funnel new prospects into the practice. While traditional outreach media campaigns (radio, TV, and newsprint) are effective, investigators needs new tools that enable them to more effectively mine their databases, consent patients efficiently, and track them through the process. An Investigator-Centric Approach The need for an investigator-centric approach to enrollment becomes clear when one critically examines a trial from the prospective patient’s perspective. A clinical trial requires that a patient is informed, consents, and takes an experimental drug. These factors are exacerbated by the fact that many patients also will receive a placebo. In this environment, it is quite easy to see how the best patient will be the one who has an established trust relationship with his or her physician. Further enhancing that trust will be education and communication from the investigator during the life of the trial. But in the busy clinical setting, investigators have limited resources and competing interests. Therefore, they must invest their clinical time wisely on the patients who are most likely to enroll and complete the trial. Automated tools for finding patients in near real-time from an electronic database in the physician’s practice could streamline this selection process. Using E-Tools for Successful Enrollment Electronic communities that enable investigators to automatically find patients in their current environment without a single change to their work practice are an ideal solution. Such programs also allow sponsors, for the first time, to find investigators during feasibility while confirming their actual existence. Web-based applications do not require any capital investment, and there is minimal training required for both sponsors and investigators. By using a patent pending process, investigators can harvest critical information from electronic medical records (where they exist) or via simple dictation in virtually any setting. Identified patient information remains in control and ownership of the investigator, making the process completely HIPAA compliant. Furthermore, a Web-based community is an ideal portal for investigator/sponsor information interchange. Credentials, protocols, and other salient information can be deposited to streamline the investigator selection and enrollment process. A Web-based portal also is an excellent quantitative tool for feasibility. It allows the comparison of real populations against other market-based research, such as script data, demographics, and site location, to make the best trial design decisions. Difficulty in enrollment is frequently cited as a major concern for a physician considering participation in a clinical trial. Installation of Web-based technology in any physician practice can provide data on the number and frequency of patients who match current trials. With this information, the physician can make an informed decision on his or her participation. Ultimately, trial enrollment will always require extensive human interaction between all interested parties. Tools that can facilitate the magic that occurs when new methods of treatment get to market can change lives. Patient Recruitment Timely Enrollment and Retention: Keys to a Successful Clinical Trial Tobin Geatz, President PharmaTech Solutions Inc., Wilmington, N.C., is an established, full-service patient-recruitment company providing innovative solutions that enable profitable clinical research. For more information, visit pharmatechsolutions.com. June 2005 VIEW on Clinical Services

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