オンライン被験者募集戦略：治験プロセスの最適化

Abstract

Overview

Introduction

With the rising costs, length and complexity of clinical trials, drug development is subject to huge delays, translating into delays in getting a drug to market and millions of dollars in lost sales. Optimizing the recruitment process through web-based technologies can cut delays in clinical trials and can also be used to maintain relationships with patients to improve the clinical trial process.

Scope of this report

• Overview of the benefits and drawbacks of online recruitment
• Analysis of the online patient recruitment process
• Analysis of the key players in patient recruitment
• Overview of patient recruitment via physicians

Research and analysis highlights

With rising internet penetration, online recruitment offers increased geographical reach and can provide huge cost savings as there is no costs for staffing or expensive advertising. A significant advantage of the internet over the other more traditional media, is that it offers an educational platform as more information can be given to patients.

Although about half a billion dollars are spent annually on mass media patient recruitment advertising and promotion, only a minority of the public has a basic understanding of the clinical research process. Poor perception was seen as the biggest hurdle in patient recruitment.

Once the potential volunteers have been targeted, it is important to convert them into participants. The key to successfully attracting and recruiting patients, is to work closely with patients and investigators, with efficient feedback mechanisms and a cohesive strategic plan in order to achieve a "patient-centric" approach for enrolment.

Key reasons to read this report

• Explore how patient recruitment for clinical trials can be maximized through web-based tools
• Understand the process of online patient recruitment
• Gain insight into how patient relationship management affects patient recruitment and 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