· subsequent retention
Up to 80% of clinical trials are estimated to experience problems with recruitment. Moreover, because of the increasingly complex nature of trials, the need for greater numbers of patients to support NDAs and the shift in focus towards chronic diseases, these problems are set to continue. In light of recent FDA changes, demand for female patients is expected to accelerate over the next few years. As a result, overcoming the recruitment bottleneck is a critical goal for pharmaceutical companies.
REPORT CONTENT
Explores the importance of clinical trial recruitment in determining both time to market as well as subsequent commercial performance;
Examines the likely impact of shifting regulatory demands and the increasing number, scale and complexity of clinical trials on demand for female participants;
Analyzes physician- and patient-centered obstacles to successful recruitment of women is it really more problematic than with men?
Draws on in-depth interviews with US and European opinion leaders to develop best-practice strategies for clinical trial recruitment, from trial design through to retention strategies
DRIVERS AND TRENDS
As demand for female patients escalates, successful recruitment and retention will depend increasingly upon sponsors and investigators willingness to adopt a more patient-centric approach to the clinical trial process.
Although attempts are underway to raise womens awareness of and involvement in clinical trials, as the demand for female patients intensifies, growth in the patient pool is unlikely to keep pace. Changes in the FDAs stance to womens inclusion in clinical trials means that pharmaceutical companies must now ensure adequate numbers of women participate in phase I and II trials to enable analysis of gender differences. At a broader level, demand for participants is expected to increase as the number of drugs in the developmental pipeline, and the scale, duration and complexity of clinical trials, increases. Unless the pool of female participants expands beyond the 5% typically quoted in the literature, investigators will increasingly have to compete, highlighting the importance of making protocols and the clinical trial process in general as patient friendly as possible.
RECRUITMENT: IS IT AN ISSUE?
Explores the role of recruitment in R&D costs and need to maximize efficiency in the face of a looming productivity crisis. Despite some womens enthusiasm for involvement, attracting and retaining adequate numbers of female patients, particularly for large-scale trials in low profile indications, can prove problematic. As many as 70% of studies involving female patients are estimated to overrun as a result of problems with enrollment, emphasizing the importance of adopting more effective recruitment and retention strategies.
· Recruitment of female patients: a problem with women, a problem with trials
· or a problem with investigators?
· Growing demand for female participants anticipated with changes to FDA
· regulations surrounding involvement in early stage trials
· Emergence of trial shoppers will makes more patient-centric trials a must
· Physician and patient negativity are a problem, but over enthusiasm can prove to be
· worse
OBSTACLES TO SUCCESSFUL RECRUITMENT
What constitutes success in clinical trial recruitment? This chapter examines the key obstacles to successful recruitment and retention. Although low awareness and understanding of clinical trials among women continues to limit participation, opinion leader research suggests that physician and protocol variables are as critical. Physicians overestimation of their ability to recruit patients, poor communication skills and lack of experience in marketing trials, may all serve to hamper enrollment.
· Increasingly complex eligibility criteria can impede rapid, high volume
· enrollment
· Some trials are more difficult to recruit for than others randomization, the
· use of placebo controls and high demands in terms of attendance may
· negatively impact womens willingness to enroll
· Companies current prioritization of initial enrollment may be short-
· sighted, given the high costs associated with participant drop out
· Low prioritization of research, time pressures and financial
· considerations critically impact physicians willingness to refer patients
OPTIMIZING RECRUITMENT SUCCESS
Overcoming the recruitment bottleneck represents a key challenge for pharma companies involved in Womens Health. This chapter provides proactive physician and patient-oriented strategies to enhance recruitment of female patients, including the potential for more active use of the Internet and patient group partnerships.
· Ensuring investigators can deliver: the positive impact site assessment,
· provision of practical support and training and input around advertising
· Plan, monitor and intervene: the importance of sponsors adopting a more
· proactive stance to clinical trials
· What do women expect from trials and does it matter? Understanding
· patient perceptions can improve enrolment, meeting expectations may
· improve retention
· Pharmaceutical companies slow to harness the power of the Internet
· Working with patient groups: a win-win strategy?
DATASETS
Figure 1: Enhancing clinical trial recruitment and retention
Figure 2: The productivity crisis in R&D
Figure 3: The rising cost of R&D over the last decade
Figure 4: The causes of trial delay: enrolment of participants is the key issue
Figure 5: Obstacles to successful recruitment of females: physician and patient
attitudes
Figure 6: Physician and patient focused strategies to improve recruitment 37
Figure 7: Datamonitors Healthcare Consultancy
Figure 8: Therapeutic Consulting capabilities
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