Clinical Trial Patient Recruitment (PH140)

Accelerate Enrollment, Increase Retention and Reduce Costs
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Published 2010
209 Pages
500+ Metrics
160+ Charts and Diagrams

Accelerate enrollment and build clinical capabilities

Understand the key factors that draw patients to clinical trials — and use this information to chart a successful recruiting strategy. Explore in-depth benchmarks focused on these areas:

  • Recruitment and retention strategies
  • Specific recruitment activities and tools
  • Structure and spending for formal recruiting efforts

Cutting Edge Information culled data from more than 80 companies — including pharmaceutical companies of all sizes, medical device and diagnostics firms — to develop a truly comprehensive look at patient recruitment. Learn how executives, directors and managers consistently overcome bottlenecks, motivate patients and meet target enrollments.

Master Recruiting and Retention

Avoid costly delays and keep trials on track - explore 16 recruitment activities by tracking who performs them and how useful and efficient they are. Break down data by phase to deploy different strategies depending on development stage.

Of course, recruiting patients is only half of the job. Discover inexpensive and simple strategies that make it easier for patients to stay engaged in trials, mitigating the effects of dropout.

Make Studies Attractive to Patients

Attracting patients requires an in-depth understanding of their needs. Learn both the tangible and emotional reasons why patients participate in trials. Use market research and patient demographics to bolster your advantage and take a more marketing-focused approach.

Deliver Site Support

Manage site and investigator expectations and strengthen site support through training to help increase patient enrollment.

Ensure adequate resources for patient recruitment

Our research finds that some companies do not plan ahead for patient recruitment — meaning that it only gets attention when problems arise. Use benchmarks to develop a recruitment process and structure that includes sufficient funding and strategic partnerships with CROs.

Clinical Trial Patient Recruitment Metrics

Chapter 1: Supporting Patient Recruitment with Increased Budgets

52 data charts focused on the following key points:

Patient recruitment budget data for sponsors, sites and CROs broken out by trial phase (Phase 1, 2, 3a and 3b, and 4)

  • Percentage of clinical trial budget dedicated to patient recruitment
  • Dedicated patient recruitment budgets (trials and sites)
  • Total trial budgets per phase at trial level and site-specific level
  • Patient recruitment budgets per patient enrolled

Patient recruitment spending data broken out by therapeutic area

  • Cardiovascular
  • Central Nervous System/Neurology
  • Type 2 Diabetes
  • Hematology
  • Infectious Disease
  • Inflammation
  • Mental Health
  • Oncology
  • Pain
  • Urology
  • Medical Device/Diagnostic

Chapter 2: Integrating CRO Outsourcing with Internal Structure

5 data charts focused on the following key points:

  • Prominence of recruiting outsourcing, including reasons sponsors contract with vendors for patient recruitment
  • Popularity of dedicated patient recruitment groups
  • Efforts to integrate patient recruitment into trial protocol design

Chapter 3: Methods and Activities to Improve Patient Recruitment

31 data charts focused on the following key points:

Data (including effectiveness rankings) for 16 patient recruitment activities

  • Evaluating site and investigators
  • Conducting patient demographic/population research
  • Working with advocacy groups
  • Organizing health fairs and community outreach
  • Training site staff/investigators on patient recruitment
  • Developing site support materials
  • Using Medical Science Liaisons (MSLs)
  • Managing a call center
  • Contacting patient referrals
  • Managing mass media marketing:
    • Radio
    • Newspaper/print
    • Television
    • Web-based marketing

Chapter 4: Patient Motivators and Patient Retention

21 data charts focused on the following key points:

Effectiveness by phase for patient motivators

  • Prospect of improved treatment
  • Convenience of sites
  • Prospect of free medication/treatment
  • Number/frequency of visits
  • Short trial duration
  • Transportation compensation
  • Monetary compensation
  • Non-monetary incentives

Percentage of companies using Patient Retention strategies, by phase and company type

  • Visit reminders by email
  • Visit reminders by text message
  • Print/paper patient support materials
  • Online patient support materials
  • Treatment follow-up by phone
  • Follow-up by web/email
  • Transportation assistance
  • Patient visits
  • Caregive support

Chapter 5: Company Profiles

Each profile contains the following information:

Patient Recruitment Profile

  • Trial information
  • Therapeutic area
  • Number of patients enrolled
  • Trial status

Company Information

  • Company type
  • Region

Patient Recruitment Spending

  • Presence/absence of dedicated budget
  • Total trial budget

Patient Recruitment Timeline

  • Targeted enrollment vs. actual enrollment
  • Months behind or ahead of schedule

Patient Recruitment Tactics

  • Patient recruitment activity
  • Company performing task (e.g., sponsor, CRO, other vendor)
  • Effectiveness ranking

Clinical Trial Patient Recruitment Report Sample

Site Evaluation

Site evaluation is perhaps the most important activity related to patient recruitment; after all, these sites are going to be attracting patients in the first place. Sites must provide an accurate picture of the types of patients that they treat, their ability to manage a clinical trial and the expertise of their staff.

The pharmaceutical industry recognizes the importance of evaluating physicians and sites for patient recruitment. Ninety-five percent of survey respondents performed this recruitment activity on their clinical trials (see Figure 3.1 in accompanying summary). Site and investigator evaluation is usually performed by specialists - only 6% of respondents reported sponsor companies handle site evaluations themselves. At 47%, CROs performed this activity most frequently.

When sponsors approach a CRO or a specialty vendor about patient recruitment, these contractors may have a dozen potential sites in mind from the beginning. A CRO will then send a request for proposal (RFP) to these specific sites, asking questions about the site and patient population. Yet rarely is trial protocol detailed enough for sites to respond accurately to the RFP. As a result, says a consultant from Company B, most sites will overstate their ability to recruit patients. The consultant recommends calling in the top three or four sites and probing more deeply into patient recruitment details.

A site manager from Company E sees the RFP process from a similar perspective. This manager believes that trial protocol is so vague at the time the RFPs are sent out that sites are not able to accurately determine the feasibility of a trial. With little information to go on, a site manager will count the number of patients with the disease in the database and return a positive response. A problem may arise if, months later, the completed trial protocol will reveal that patients must comply to four or five more criteria. The Company E site manager believes that the more details a sponsor can offer upfront in an RFP, the better that sites can evaluate their recruitment potential.

A key to site evaluation is learning about the patient population that the site has access to. One method for accurately assessing the patient population leverages electronic medical records (EMRs). To illustrate their importance with an example: an executive from Company E manages a network of clinical trials. For new sites attempting to join the network, EMRs are a must. Once the qualifying patients are identified, the trial manager can flag each patient record using EMRs so that the site staff remembers to offer the clinical trial as a potential treatment. What's more, each qualifying patient will receive a letter or an email about the trial before the patient even walks through the door. This high level of automated efficiency can only be achieved with sites that have EMRs.

Nearly all respondents agree on the effectiveness of site evaluation as a patient recruitment activity. Figure 3.2 [shown in accompanying summary] is included reveals that this recruitment activity received an average effectiveness rating of 8.0 - highest among all 16 recruitment activities. The 22 respondents from Phase 3a trials rated evaluating sites an 8.6, the highest of any activity during any phase of development. In other words, understanding the true recruitment capabilities of a potential site is the most important activity a sponsor can do.

Clinical Trial Patient Recruitment Report Sample

Site Evaluation

Site evaluation is perhaps the most important activity related to patient recruitment; after all, these sites are going to be attracting patients in the first place. Sites must provide an accurate picture of the types of patients that they treat, their ability to manage a clinical trial and the expertise of their staff.

The pharmaceutical industry recognizes the importance of evaluating physicians and sites for patient recruitment. Ninety-five percent of survey respondents performed this recruitment activity on their clinical trials. Site and investigator evaluation is usually performed by specialists - only 6% of respondents reported sponsor companies handle site evaluations themselves. At 47%, CROs performed this activity most frequently.

When sponsors approach a CRO or a specialty vendor about patient recruitment, these contractors may have a dozen potential sites in mind from the beginning. A CRO will then send a request for proposal (RFP) to these specific sites, asking questions about the site and patient population. Yet rarely is trial protocol detailed enough for sites to respond accurately to the RFP. As a result, says a consultant from Company B, most sites will overstate their ability to recruit patients. The consultant recommends calling in the top three or four sites and probing more deeply into patient recruitment details.

A site manager from Company E sees the RFP process from a similar perspective. This manager believes that trial protocol is so vague at the time the RFPs are sent out that sites are not able to accurately determine the feasibility of a trial. With little information to go on, a site manager will count the number of patients with the disease in the database and return a positive response. A problem may arise if, months later, the completed trial protocol will reveal that patients must comply to four or five more criteria. The Company E site manager believes that the more details a sponsor can offer upfront in an RFP, the better that sites can evaluate their recruitment potential.

A key to site evaluation is learning about the patient population that the site has access to. One method for accurately assessing the patient population leverages electronic medical records (EMRs). To illustrate their importance with an example: an executive from Company E manages a network of clinical trials. For new sites attempting to join the network, EMRs are a must. Once the qualifying patients are identified, the trial manager can flag each patient record using EMRs so that the site staff remembers to offer the clinical trial as a potential treatment. What's more, each qualifying patient will receive a letter or an email about the trial before the patient even walks through the door. This high level of automated efficiency can only be achieved with sites that have EMRs.

Nearly all respondents agree on the effectiveness of site evaluation as a patient recruitment activity. Figure 3.2 reveals that this recruitment activity received an average effectiveness rating of 8.0 - highest among all 16 recruitment activities. The 22 respondents from Phase 3a trials rated evaluating sites an 8.6, the highest of any activity during any phase of development. In other words, understanding the true recruitment capabilities of a potential site is the most important activity a sponsor can do.