Strategic Perspectives: Clinical Trial Recruitment in Women's Health- Adopting a More Patient Centric Approach

SUMMARY

Introduction

Up to 80% of clinical trials are estimated to experience problems withrecruitment. Moreover, because of the increasingly complex nature of trials, theneed for greater numbers of patients to support NDAs and the shift in focustowards chronic diseases, these problems are set to continue. In light of recentFDA changes, demand for female patients is expected to accelerate over the nextfew years. As a result, overcoming the recruitment bottleneck is a critical goalfor pharmaceutical companies.

Scope

• Explores the importance of clinical trial recruitment in determining bothtime to market and subsequent commercial performance
• Examines the impact of shifting regulatory demands and the increasingnumber, scale and complexity of clinical trials on need for femaleparticipants
• Analyzes physician and patient-centered obstacles to recruitment of women,and determines if it is more problematic to recruit women than men
• Draws on in-depth interviews with US and European opinion leaders todevelop best-practice strategies for recruitment

Report Highlights

As demand for female patients escalates, successful recruitment and retentionwill depend increasingly upon sponsors' and investigators' willingness to adopta more patient-centric approach to the clinical trial process. This analysisexplores proactive physician and patient-oriented strategies to enhancerecruitment of female patients, including the potential for more active use ofthe Internet and patient group partnerships.

Reasons to Purchase

• Identifies the key physician and patient variables impacting recruitment
• Highlights those trial designs and indications which are likely to posethe greatest challenges in terms of the recruitment of women
• Provides strategies to optimize trial design and implementation with aview to maximizing the speed of initial enrolment and subsequent retention

TABLE OF CONTENTS

Summary of Contents

Overview

Introduction

Up to 80% of clinical trials are estimated to experience problems withrecruitment. Moreover, given the increasing complexity of trials, a need forgreater numbers of patients to support NDAs and a shift in focus towards chronicdiseases, these problems look set to continue. In light of recent FDA changes,demand for female patients in particular, is expected to accelerate over thenext few years. As a result, overcoming the recruitment bottleneck is anincreasingly critical goal.

Scope

• Explores the importance of clinical trial recruitment in determining bothtime to market and determining subsequent commercial performance

• Examines the impact of shifting regulatory demands and increasing number,scale and complexity of clinical trial's on demand for female participants

• Analyzes physician- and patient-centered obstacles to successfulrecruitment of women – is it really more problematic than with men?

• Draws on in-depth interviews with US and European opinion leaders todevelop best-practice strategies for recruitment

Report Highlights

As demand for female patients escalates, successful recruitment and retentionwill depend increasingly upon sponsors' and investigators' willingness toadopt a more patient-centric approach to the clinical trial process. This reportexplores proactive physician and patient-oriented strategies to enhancerecruitment of female patients, including the potential for more active use ofthe Internet and patient group partnerships.

Reasons to Purchase

• Identifies the key physician and patient variables impacting recruitment

• Highlights those trial designs and indications which are likely to posethe greatest challenges in terms of the recruitment of women

• Provides strategies to optimize trial design and implementation with aview to maximizing the speed of initial enrolment and subsequent retention

Up to 80% of clinical trials are estimated to experience problems withrecruitment. Moreover, because of the increasingly complex nature of trials, theneed for greater numbers of patients to support NDAs and the shift in focustowards chronic diseases, these problems are set to continue. In light of recentFDA changes, demand for female patients is expected to accelerate over the nextfew years. As a result, overcoming the recruitment bottleneck is a critical goalfor pharmaceutical companies.

REPORT CONTENT

Explores the importance of clinical trial recruitment in determining bothtime to market as well as subsequent commercial performance;

Examines the likely impact of shifting regulatory demands and the increasingnumber, scale and complexity of clinical trials on demand for femaleparticipants;

Analyzes physician- and patient-centered obstacles to successful recruitmentof women – is it really more problematic than with men?

Draws on in-depth interviews with US and European opinion leaders to developbest-practice strategies for clinical trial recruitment, from trial designthrough to retention strategies

DRIVERS AND TRENDS

As demand for female patients escalates, successful recruitment and retentionwill depend increasingly upon sponsors' and investigators' willingness toadopt a more patient-centric approach to the clinical trial process.

Although attempts are underway to raise women' s awareness of andinvolvement in clinical trials, as the demand for female patients intensifies,growth in the patient pool is unlikely to keep pace. Changes in the FDA' sstance to women' s inclusion in clinical trials means that pharmaceuticalcompanies must now ensure adequate numbers of women participate in phase I andII trials to enable analysis of gender differences. At a broader level, demandfor participants is expected to increase as the number of drugs in thedevelopmental pipeline, and the scale, duration and complexity of clinicaltrials, increases. Unless the pool of female participants expands beyond the 5%typically quoted in the literature, investigators will increasingly have tocompete, highlighting the importance of making protocols and the clinical trialprocess in general as 'patient friendly' as possible.

RECRUITMENT: IS IT AN ISSUE?

Explores the role of recruitment in R&D costs and need to maximizeefficiency in the face of a looming productivity crisis. Despite some women' senthusiasm for involvement, attracting and retaining adequate numbers of femalepatients, particularly for large-scale trials in low profile indications, canprove problematic. As many as 70% of studies involving female patients areestimated to overrun as a result of problems with enrollment, emphasizing theimportance of adopting more effective recruitment and retention strategies.

• Recruitment of female patients: a problem with women, a problem withtrials
• 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 amust
• Physician and patient negativity are a problem, but over enthusiasm canprove to be
• worse

OBSTACLES TO SUCCESSFUL RECRUITMENT

What constitutes success in clinical trial recruitment? This chapter examinesthe key obstacles to successful recruitment and retention. Although lowawareness and understanding of clinical trials among women continues to limitparticipation, opinion leader research suggests that physician and protocolvariables are as critical. Physicians' overestimation of their ability torecruit 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 women' s 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 referpatients

OPTIMIZING RECRUITMENT SUCCESS

Overcoming the recruitment bottleneck represents a key challenge for pharmacompanies involved in Women' s Health. This chapter provides proactivephysician and patient-oriented strategies to enhance recruitment of femalepatients, including the potential for more active use of the Internet andpatient 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 keyissue

Figure 5: Obstacles to successful recruitment of females: physician andpatient

attitudes

Figure 6: Physician and patient focused strategies to improve recruitment 37

Figure 7: Datamonitor' s Healthcare Consultancy

Figure 8: Therapeutic Consulting capabilities