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Patients Wanted: Communication, Marketing and Tech

Posted on: 26 Feb 03


The process of finding, screening, and recruiting clinical trial patients at multiple research sites is a challenge for even the largest pharmaceutical sponsors and clinical research organizations.
The Patient Recruitment Challenge The process of finding, screening, and recruiting clinical trial patients at multiple research sites is a challenge for even the largest pharmaceutical sponsors and clinical research organizations. US data indicates that the number of clinical trials per NDA more than doubled over the period 1985-1995, with NDAs approved in 1994-1995 containing on average 68 clinical trials ,1-3. It has been suggested that increasing the number of patients required for NDA clinical trial databases could reduce post-marketing adverse events and thus recruitment strategy will be crucial to a trial’s success1-3. It has also been pointed out that the nature of the drugs being trialed will affect statistics such as the number of subjects in a trial1. For example, in 1998, trial sizes ranged from an estimated 212 patients for Xeloda, a breast cancer drug that received accelerated approval based largely on a 162-subject Phase II study, to the 16,000 subjects enrolled worldwide for Actonel, a drug for Paget’s disease. 1 An analysis by CMR International, of 23 clinical dossiers submitted between February 1995 and April 1999 to regulatory authorities in Europe, the USA and Japan, found that the dossiers contained on average 35 clinical trials, involving on average more than 4,000 subjects each.1,4 Using communication and technology In recent years there has been an increase in media coverage of all the aspects – good and bad – of development-stage medical devices. This has led to a subsequent increase in the number of self-referred patients participating in clinical trials. “This phenomenon may be attributed to a change in the way device manufacturers are promoting their investigational products.”5 Patients have now more access to data through the Internet, and some device firms have followed the lead of the pharmaceutical industry and have implemented direct-to-consumer (DTC) marketing schemes. In addition to improving patient awareness about devices, DTC advertising and patient recruitment can help manufacturers avoid potential conflicts of interest on the part of investigators. Project management software is essential to help identify and plan for recruitment/study milestones, including the approval of campaign materials by institutional review boards and the timing of "deliverables" to prospective patients and other members of the trial team. Enrollment programs must track each study site's response to the referrals generated by the recruitment campaign. Such tools can also help refine tactics throughout the program, while customizing elements of the recruitment program to each investigator's preferences. Within the USA, sponsors and CROs are now posting information regarding their clinical trials on the Internet. This is usually featured on web sites of research center, and patient associations or advocacy groups. The Internet provides several benefits to the potential trial patient. First, it offers a unique medium for interaction and discussion between current and prospective patients as well as discussions with investigators. When surfing the Internet, the potential patient is the active recipient of target information, which is inexpensive and accessible 24 hours a day. In addition, when potential patients surf the Internet, they are usually highly motivated and self-selecting. Another crucial element of the recruitment process is in-depth knowledge of the patient profile. Enrollment consultants can provide special expertise in this area by working with therapeutically focused clinicians who review historic data and demographic factors before initiating any recruitment programs. Trial planners must understand the clinical trial's market demographics, patient population, and possible barriers to the study. Involving patients Clinical and community outreach initiatives can be helpful for enrolling patients in clinical trials with narrow inclusion criteria. Target populations for the outreach programs may include clinically defined patients, caregivers, families, support groups, and community-based referral sources. Such initiatives can include educational and medical information programs delivered on-site at hospitals, residential care facilities, community health and senior centers, and affinity group meetings run by skilled MDs, PhDs, and other experts trained in the specific clinical trial protocol. Study planners must also enlist community support groups to reach patients and families who suffer from specific ailments. Many factors, including involvement in concurrent clinical studies, can distract clinical trial processes and procedures. References 1. Kermani F and Findlay G (2000). The Pharmaceutical R&D Compendium. 2. Peck CC. Drug Development: Improving the Process. Food and Drug Law Journal 1997; 52/2:163-167. 3. Woodcock J. Larger Clinical Trials Could Detect AES Earlier. The Pink Sheet. 10 May 1999. 4. Hynes CL, McAuslane JAN and Walker SR. Issues of Concern in Clinical Development: The Growing Size of the Clinical Dossier. Proceedings of a CMR International Workshop. CMR International 2000. 5. “Consumer Promotion Raising Number of Self-Referred Clinical Trial Patients” The Gray Sheet, March 26, 2001, p. 27.

Dr Faiz Kermani

Last updated on: 27/08/2010 11:40:18

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