Online patient recruitment and its impact on patient relationship management

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.

Report 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.
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CHAPTER 1 EXECUTIVE SUMMARY 4
Scope of the report 4
Key findings 4
CHAPTER 2 INTRODUCTION TO CLINICAL TRIALS 10
The ongoing problem of recruiting patients for clinical trials 10
Patient recruitment remains a major challenge for pharma 11
Patient recruitment options 12
Recruitment via physicians is the traditional method 13
Recruitment through media is the most expensive method 14
Online patient recruitment is set to increase due to rising internet penetration 14
Use of technology in clinical trials and recruitment 15
Electronic data capture (eDC) increases efficiency over a paper-based system 15
Electronic patient diaries facilitate data capture 16
eSubmissions are replacing paper-based applications 16
Online communities are becoming increasingly popular and influential with patients 16
Clinical trial websites and online patient recruitment capture a highly motivated and self-selected patient population 17
CHAPTER 3 THE ONLINE PATIENT RECRUITMENT PROCESS 18
Key steps in the online patient recruitment process 18
Online recruitment offers a more targeted approach at a lower cost 19
Advantages of online recruitment 21
Cost savings - web-based tools are less expensive than traditional methods 21
Time savings - online recruitment decreases delays 21
The internet provides a platform for patient education 21
Increase geographical scope 22
More information can be given and collected 22
Disadvantages and barriers to online patient recruitment 22
Patient confusion regarding site or scientific material 22
Patients may not have access to adequate information 23
Patient fears regarding confidentiality or security over online activity 23
Unmet needs in online patient recruitment and its impact on patient relationship management 23
Poor perception of clinical trials was seen as the biggest problem 26
The beginning of patient enrollment: attraction and recruitment 27
Cast a wide net 28
Attract carers 28
The rise of the ""patient-centric"" approach to clinical trial recruitment 28
Every patient is special 29
Communicate with patients 29
Keep patients informed 30
Transparency 31
Patient awareness and perception 31
Screening - selecting the right patients 32
Retaining patients until the end of the study 32
Online compliance programs can aid patient retention 33
Maintain close contact and build relationships with patients 33
Patients need to be kept motivated throughout the clinical trial process 33
Ethical considerations during clinical trial recruitment and retention 34
Patient feedback can improve the clinical trial process 35
Patient feedback and enhanced communication with the patient can also be used to improve the treatment once the drug is approved 36
The importance of patient feedback for improving clinical trial protocols and treatments depends on disease characteristics 36
CHAPTER 4 KEY PLAYERS IN ONLINE PATIENT RECRUITMENT 39
Pharma companies list their studies on their own branded websites or on www.clinicaltrials.gov 39
Contract research organizations (CROs) are being increasingly employed to optimize clinical trials and recruitment 40
Third-party websites provide comprehensive information and databases 41
Patient advocacy groups (PAGs) attract a lot of traffic thus presenting as an ideal target for partnership with pharma companies 41
Clinical trial registries are becoming increasingly popular as now Pharma companies must list their studies 43
Case studies of Internet patient-facing clinical trial recruitment websites 44
The breadth and depth of information on websites is variable 44
Eli Lilly / clinicaltrials.gov 46
Roche 49
CenterWatch 51
National Cancer Institute (NCI) 53
CHAPTER 5 PATIENT ATTRACTION AND RETENTION THROUGH PHYSICIANS 55
Recruitment via physicians is the most common way of enrolling patients due to their trusted relationship 55
The benefits of participation must be highlighted to the physicians 55
The internet can enhance communication with physicians and provide large databases for recruitment 56
Clinical Trial Network - an example of an investigator recruitment website 56
Online investigator recruitment is an underused strategy 57
CHAPTER 6 BIBLIOGRAPHY 59
Publications and online articles 59
Websites 60
Datamonitor resources 61
Suggested reading 61
APPENDIX 63
Glossary of terms 63
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Table 1: The cost and number of volunteers increases with each phase 11
Table 2: Scorecard showing importance of patient feedback for four different disease area 38
Figure 1: Average delays for each phase of the clinical trial process 11
Figure 2: Summary of procedures in patient recruitment via three different channels 13
Figure 3: Flow of the online patient recruitment process 18
Figure 4: Merck's patient recruitment funnel shows how potential patients go through five screening phases 19
Figure 5: Online patient recruitment has significantly more advantages 20
Figure 6: Drivers for patient participation in clinical trials 24
Figure 7: Promotion of clinical trial websites must be increased 25
Figure 8: Factors contributing to a patient-centric approach to recruitment 29
Figure 9: Details given to patients should be concise but comprehensive 31
Figure 10: Comparison of information shown by four clinical trial websites 46
Figure 11: Half snapshot of clinicaltrials.gov (redirected from Eli Lilly) showing a clinical trial listing 48
Figure 12: Half snapshot of Roche's clinical trial website 50
Figure 13: Snapshot of a clinical trial listing from CenterWatch's website 52
Figure 14: Snapshot of a clinical trial listing on NCI's website 54
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