eHealthInsight Series: Online Patient Recruitment Strategies - Optimizing the clinical trial process

Table of Contents

• CHAPTER 1 EXECUTIVE SUMMARY
  • Scope of the report
  • Key findings
• CHAPTER 2 INTRODUCTION TO CLINICAL TRIALS
  • The ongoing problem of recruiting patients for clinical trials
    • Patient recruitment remains a major challenge for pharma
  • Patient recruitment options
    • Recruitment via physicians is the traditional method
    • Recruitment through media is the most expensive method
    • Online patient recruitment is set to increase due to rising internet penetration
  • Use of technology in clinical trials and recruitment
    • Electronic data capture (eDC) increases efficiency over a paper-based system
    • Electronic patient diaries facilitate data capture
    • eSubmissions are replacing paper-based applications
    • Online communities are becoming increasingly popular and influential with patients
    • Clinical trial websites and online patient recruitment capture a highly motivated and self-selected patient population
• CHAPTER 3 THE ONLINE PATIENT RECRUITMENT PROCESS
  • Key steps in the online patient recruitment process
  • Online recruitment offers a more targeted approach at a lower cost
    • Advantages of online recruitment
      • Cost savings - web-based tools are less expensive than traditional methods
      • Time savings - online recruitment decreases delays
      • The internet provides a platform for patient education
      • Increase geographical scope
      • More information can be given and collected
    • Disadvantages and barriers to online patient recruitment
      • Patient confusion regarding site or scientific material
      • Patients may not have access to adequate information
      • Patient fears regarding confidentiality or security over online activity
    • Unmet needs in online patient recruitment and its impact on patient relationship management
      • Poor perception of clinical trials was seen as the biggest problem
  • The beginning of patient enrollment: attraction and recruitment
    • Cast a wide net
      • Attract carers
    • The rise of the "patient-centric" approach to clinical trial recruitment
      • Every patient is special
      • Communicate with patients
      • Keep patients informed
      • Transparency
      • Patient awareness and perception
  • Screening - selecting the right patients
  • Retaining patients until the end of the study
    • Online compliance programs can aid patient retention
    • Maintain close contact and build relationships with patients
    • Patients need to be kept motivated throughout the clinical trial process
    • Ethical considerations during clinical trial recruitment and retention
  • Patient feedback can improve the clinical trial process
    • Patient feedback and enhanced communication with the patient can also be used to improve the treatment once the drug is approved
    • The importance of patient feedback for improving clinical trial protocols and treatments depends on disease characteristics
• CHAPTER 4 KEY PLAYERS IN ONLINE PATIENT RECRUITMENT
  • Pharma companies list their studies on their own branded websites
  • Contract research organizations (CROs) are being increasingly employed to optimize clinical trials and recruitment
  • Third-party websites provide comprehensive information and databases
  • Patient advocacy groups (PAGs) attract a lot of traffic thus presenting as an ideal target for partnership with pharma companies
  • Clinical trial registries are becoming increasingly popular as now Pharma companies must list their studies
  • Case studies of Internet patient-facing clinical trial recruitment websites
    • The breadth and depth of information on websites is variable
    • Eli Lilly / clinicaltrials.gov
    • Roche
    • CenterWatch
    • National Cancer Institute (NCI)
• CHAPTER 5 PATIENT ATTRACTION AND RETENTION THROUGH PHYSICIANS
  • Recruitment via physicians is the most common way of enrolling patients due to their trusted relationship
  • The benefits of participation must be highlighted to the physicians
  • The internet can enhance communication with physicians and provide large databases for recruitment
    • Clinical Trial Network - an example of an investigator recruitment website
    • Online investigator recruitment is an underused strategy
• CHAPTER 6 BIBLIOGRAPHY
  • Publications and online articles
  • Websites
  • Datamonitor resources
  • Suggested reading
• APPENDIX
  • Glossary of terms
  • List of Tables
• Table 1: The cost and number of volunteers increases with each phase
• Table 2: Scorecard showing importance of patient feedback for four different disease area
• List of Figures
  • Figure 1: Average delays for each phase of the clinical trial process
  • Figure 2: Summary of procedures in patient recruitment via three different channels
  • Figure 3: Flow of the online patient recruitment process
  • Figure 4: Merck' s patient recruitment funnel shows how potential patients go through five screening phases
  • Figure 5: Online patient recruitment has significantly more advantages
  • Figure 6: Drivers for patient participation in clinical trials
  • Figure 7: Promotion of clinical trial websites must be increased
  • Figure 8: Factors contributing to a patient-centric approach to recruitment
  • Figure 9: Details given to patients should be concise but comprehensive
  • Figure 10: Comparison of information shown by four clinical trial websites
  • Figure 11: Half snapshot of clinicaltrials.gov(redirected from Eli Lilly) showing a clinical trial listing
  • Figure 12: Half snapshot of Roche' s clinical trial website
  • Figure 13: Snapshot of a clinical trial listing from CenterWatch' s website
  • Figure 14: Snapshot of a clinical trial listing on NCI' s website