Insights > Integrated Product Development

Effective patient recruitment can accelerate the commercialization of new medicines more than any other single optimization. Unfortunately, patient recruitment is becoming increasingly complex.  There are many challenges to overcome including increased complexity of clinical trials, competition for patients, rising patient expectations, and tight timelines.  There is significant innovation ongoing to address these challenges including patient self-referral from sponsor websites and patient matching from healthcare data sources.  However, these approaches are often fragmentary, extremely expensive and consequently, have limited impact.

Consider patient recruitment as a process which includes six main steps – plan, find, engage, screen, enroll, dynamically manage. To facilitate significant improvement, it’s important to look outside the patient recruitment area and consider “best in class” use cases.  One of these is Supply Chain Management, a discipline that has been developed for managing processes.  Although clearly patients are not products or services, applying supply chain management principles can help us improve many aspects of the patient recruitment process.  Key principles include customer focus, planning, agility, collaboration, integration and visibility.  Applying these to the patient recruitment process has been demonstrated to improve patient recruitment by more than 20% across many disease areas. A few key learnings are highlighted below:

Customer focus

• Patients are not widgets. Focus on patient decision making and addressing their core needs
• For internet recruitment, patient navigators can greatly increase screening likelihood
• HCPs are highly trusted but often too busy to refer patients. Provide creative, compelling, easily accessible and integrated medical information

Planning

• Understand target patient population and how best to reach them
• Have a clear recruitment strategy, with multiple channels and contingency plans
• Develop a clear business case for non-traditional approaches

Agility

• Use multiple recruitment channels
• Actively manage social media campaigns

Collaboration

• Work closely with HCPs to match patients at sites using multiple approaches
• Focus on recruitment vendors who understand patient population and contract based on patient randomization, not identification
• Site / sponsor / tech partnership is vital. Limit the number of sites in a study and provide simpler tools / workflows, sponsor resource at site and joined up planning

Integration

• Identify key activities, data and performance measures in the patient recruitment process
• Ensure seamless and dynamic connectivity

Visibility

• Monitor screening activities to understand enrollment challenges g What sites are getting referrals? Where are diverse candidates?  What I/E criteria are failing?
• Managed study level recruitment data and information dynamically
• Create integrated reports to learn across multiple studies at disease / therapy level
• Continuously improve future recruitment activities

In summary, many sponsors today view recruitment as a study-level challenge rather than an organizational competency. Recruitment activities need to be joined up seamlessly and managed dynamically across all process steps. Patient recruitment done well needs to be patient-focused, well-planned, agile, collaborative, integrated, and most-of-all visible – just like a well-run supply chain.

Written by John Murray-Pryce

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