Patient Feasibility and Site Selection
Patient Feasibility and Site Selection
Effective site selection is vital for a clinical trial’s success, while patient feasibility assessments ensure successful recruitment and retention. WEP uses a comprehensive, structured approach to identify and select sites and patients strategically, maximizing the trial’s ability to meet recruitment targets and achieve successful outcomes.
WEP will support Sponsors with the following:
Define the Patient Selection Criteria
- Inclusion & Exclusion Criteria: Carefully review protocol-defined criteria (age, disease severity, prior treatments, comorbidities, biomarkers, etc.).
- Epidemiological Data Analysis: Use public health databases (e.g., WHO, CDC, NIH) and disease registries to estimate patient prevalence and incidence.
- Patient Journey Mapping: Understand how patients progress through the disease and standard treatment pathways to identify potential recruitment barriers.
- Direct Patient Insights: Use patient advocacy groups, social media, and focus groups to gauge interest and concerns.
- Create Patient Feasibility Questionnaire: Assess how practical and likely it is to recruit and retain patients for a specific study, treatment, or service.
Define Site Selection Criteria
- Site Databases & Networks: Utilize databases like ClinicalTrials.gov, TrialTroves, and investigator networks to identify experienced sites.
- Real-World Evidence (RWE) & Epidemiological Data: Use claims data, electronic health records (EHR), and disease registries to assess patient availability.
- Site Infrastructure: Ensure the site has the necessary facilities, equipment, and trained staff to conduct the study efficiently.
- Investigator Expertise: Evaluate the qualifications, experience, and track record of principal investigators (PIs) in conducting similar trials.
- Patient Recruitment Potential: Assess whether target sites have access to the target patient population based on epidemiology and historical recruitment performance.
- Site Investigator Feedback: Ask potential trial sites about patient recruitment challenges and strategies.
Consider Geographic & Logistical Factors
- Site Location: Ensure proximity to patient populations and accessibility for trial participants.
- Regulatory Timelines: Evaluate country-specific regulatory approval timelines, as some regions have faster processes.
- Competing Trials: Avoid sites with ongoing competing trials that could impact recruitment.
Leverage Technology & AI for Site Selection
- AI-Based Predictive Analytics: Use AI-powered tools like IBM Watson, Medidata AI, or TriNetX to predict site performance based on historical data.
- Electronic Health Records (EHR) Mining: Identify potential patient pools within healthcare systems.
- Decentralized & Hybrid Models: Consider remote patient monitoring or decentralized trial elements to enhance recruitment.
Conduct Feasibility Surveys & Pre-Screening
- Send feasibility questionnaires to shortlisted sites to assess:
- Interest & availability
- Experience with similar trials
- Expected recruitment potential
- Staffing capacity
- Data Quality & Compliance History: Review past performance in terms of protocol adherence, data integrity, and compliance with regulatory requirements.
- Historical Data & Benchmarks: Leverage past performance metrics from previous trials (e.g., enrollment rates, retention rates, data query rates).
- Regulatory & Ethical Compliance: Check the site’s familiarity with Good Clinical Practice (GCP), Institutional Review Board (IRB) approval processes, and local regulatory requirements.
- Feasibility Visits or Virtual Assessments: To verify responses and inspect infrastructure.
- Run a Small-Scale Pilot: Or pre-screening at selected sites to validate recruitment estimates before full study launch.
Develop a Recruitment & Retention Strategy
- Site-Specific Recruitment Plans: Tailor recruitment efforts based on site demographics.
- Community & Physician Engagement: Educate referring physicians and involve patient advocacy groups.
- Patient Support Initiatives: Offer travel reimbursement, flexible scheduling, and caregiver support if needed.
Continuous Site Performance Monitoring
- Implement real-time tracking of recruitment rates, dropout rates, and data quality during the trial to quickly address underperforming sites.
Need more information?
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