Market Report Source

Overview

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 or on http://www.clinicaltrials.gov
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