This checklist is a practical tool for clinical development professionals at sponsor and CRO organizations. It reflects regulatory guidance (FDA, ICH E6(R3), EMA), evidence-based practices, and operational strategies to optimize recruitment and retention of patients in cardiometabolic clinical trials. such as diabetes, obesity, heart failure, chronic kidney disease, atherosclerotic cardiovascular disease.
Governance and Recruitment Action Plan
- Draft a Recruitment Action Plan with enrollment goals by age, sex, race/ethnicity; include rationale, tactics, and compliance with regulatory guidance.
- Define a participation-to-prevalence ratio target range of 0.8–1.2 for key subgroups; require remediation if out of range.
- Assign accountable owners for recruitment, retention, and representativeness, with weekly key performance indicators (KPIs) and dashboards.
- Budget for participant support (transport, childcare, parking, stipends) and site navigators up front.
- Pre-specify ethical compensation policy and reimbursement process; simplify documentation for participants.
- Codify data governance and privacy for centralized prescreening and multi-channel outreach, aligned with ICH E6(R3).
Protocol and Eligibility
- Run a screen-failure simulation (hemoglobin A1c, body mass index, estimated Glomerular Filtration Rate, blood pressure, background medications) and relax thresholds where feasible.
- Minimize exclusions related to stable comorbidities/polypharmacy common in cardiometabolic patients, in line with FDA inclusive enrollment guidance.
- Conduct protocol feasibility testing using real-world data claims and electronic health record (EHR) files before finalization.
- Engage patient advisory input to optimize eligibility realism.
- Allow usual-care comparators and pragmatic endpoints (ePatient Reported Outcomes, claims/EHR) where appropriate.
- Plan for concurrent standard therapies (e.g., GLP-1s, SGLT2 inhibitors) with clear rescue/adjustment rules.
- Reduce visit burden: wider visit windows, combined assessments, remote vitals.
- Translate all participant-facing materials; target ≤8th-grade readability and health literacy best practices.
Decentralized and Pragmatic Operations
- Offer eConsent with an in-person alternative; include teach-back to confirm understanding.
- Enable tele-visits, home health (phlebotomy, vitals), and local labs/pharmacies.
- Use remote patient monitoring devices (blood pressure cuff, scale) where validated and fit-for-purpose.
- Pre-plan logistics for investigational product shipment/chain-of-custody for home dosing where applicable.
- Blend digital convenience with in-person alternatives to avoid digital access bias.
Site Strategy
- Use EHR/claims heatmaps to pick regions with high disease burden and underrepresented populations.
- Balance academic centers with Federally Qualified Health Centers, safety-net hospitals, and community clinics.
- Pre-contract readiness: share computable phenotypes, prescreen lists, and outreach scripts before site initiation visit (SIV).
- Appropriately resource sites: fund patient navigators or part-time recruiters; define micro-service level agreements (e.g., referral to contact <72h).
- Limit low-performing sites; shift activation to proven performers; avoid oversaturating competing geographies.
- Set site performance metrics: time-to-first-patient ≤60 days post-SIV, minimum enrollments/site/month.
- Align site hours with patient schedules (evenings/weekends).
Patient Outreach and Access
- Partner with community venues (churches, barbershops, pharmacies) for education and referrals.
- Deploy community health workers (CHWs) to provide trial navigation, education, and follow-up.
- Implement multi-channel outreach from centralized prescreening (SMS, email, phone, letters).
- Offer transportation, parking vouchers, rideshare, and provide childcare/meal stipends as needed.
- Create bilingual, culturally tailored recruitment scripts, not just materials, with a clear value proposition and visuals.
- Use mobile trial units or pop-up clinics in rural and underserved communities.
Consent and Onboarding
- Use a single, plain-language overview sheet plus detailed consent; confirm understanding via teach-back.
- Provide a ‘first-visit concierge’: step-by-step logistics, maps, contacts, what-to-expect video.
- Set up an automated reminder system (SMS/phone/email) for visits, labs, and diaries.
- Enroll caregivers where relevant (e.g., heart failure/chronic kidney disease) and support their needs.
Retention and Engagement
- Offer flexible scheduling and rescheduling without penalty; include a missed-visit recovery plan.
- Maintain regular check-ins between visits (via CHWs, coordinators, or digital engagement tools).
- Provide home or near-home alternatives for burdensome procedures when feasible.
- Return individual results (labs, vitals) and periodic study updates/newsletters.
- Implement patient engagement platforms (apps, text check-ins, push notifications) for ongoing connection.
- Leverage peer-to-peer patient ambassadors or advocacy group liaisons for trust-building and support.
- Conduct exit interviews among withdrawing participants to capture learnings and adapt practices.
- Use a retention-risk flag system (transport, work hours, childcare) at screening with documented mitigation steps.
- Provide consistent, transparent reimbursement, paid via participant-preferred method.
Data, Technology, and Metrics
- Establish a sponsor-run, IRB-approved centralized EHR prescreening hub.
- Define and track funnel metrics: outreach→contact→prequal→screen→randomize; by site and subgroup.
- Monitor representativeness weekly (sex, race/ethnicity, age, rurality) and trigger remediation plans.
- Publish site scorecards (time-to-first-patient, enrollment rate, screen fail %, retention).
- Ensure privacy/security controls for all electronic systems and participant data (ICH E6[R3]).
- Document essential records and validation for computerized systems.
At Alliance Clinical Network, we believe successful cardiometabolic trials require more than great science; they demand removing the barriers that prevent patients from enrolling and staying engaged. Contact us today and learn how we can help you achieve your recruitment and retention goals.
This checklist is a practical tool for clinical development professionals at sponsor and CRO organizations. It reflects regulatory guidance (FDA, ICH E6(R3), EMA), evidence-based practices, and operational strategies to optimize recruitment and retention of patients in cardiometabolic clinical trials. such as diabetes, obesity, heart failure, chronic kidney disease, atherosclerotic cardiovascular disease.
Governance and Recruitment Action Plan
- Draft a Recruitment Action Plan with enrollment goals by age, sex, race/ethnicity; include rationale, tactics, and compliance with regulatory guidance.
- Define a participation-to-prevalence ratio target range of 0.8–1.2 for key subgroups; require remediation if out of range.
- Assign accountable owners for recruitment, retention, and representativeness, with weekly key performance indicators (KPIs) and dashboards.
- Budget for participant support (transport, childcare, parking, stipends) and site navigators up front.
- Pre-specify ethical compensation policy and reimbursement process; simplify documentation for participants.
- Codify data governance and privacy for centralized prescreening and multi-channel outreach, aligned with ICH E6(R3).
Protocol and Eligibility
- Run a screen-failure simulation (hemoglobin A1c, body mass index, estimated Glomerular Filtration Rate, blood pressure, background medications) and relax thresholds where feasible.
- Minimize exclusions related to stable comorbidities/polypharmacy common in cardiometabolic patients, in line with FDA inclusive enrollment guidance.
- Conduct protocol feasibility testing using real-world data claims and electronic health record (EHR) files before finalization.
- Engage patient advisory input to optimize eligibility realism.
- Allow usual-care comparators and pragmatic endpoints (ePatient Reported Outcomes, claims/EHR) where appropriate.
- Plan for concurrent standard therapies (e.g., GLP-1s, SGLT2 inhibitors) with clear rescue/adjustment rules.
- Reduce visit burden: wider visit windows, combined assessments, remote vitals.
- Translate all participant-facing materials; target ≤8th-grade readability and health literacy best practices.
Decentralized and Pragmatic Operations
- Offer eConsent with an in-person alternative; include teach-back to confirm understanding.
- Enable tele-visits, home health (phlebotomy, vitals), and local labs/pharmacies.
- Use remote patient monitoring devices (blood pressure cuff, scale) where validated and fit-for-purpose.
- Pre-plan logistics for investigational product shipment/chain-of-custody for home dosing where applicable.
- Blend digital convenience with in-person alternatives to avoid digital access bias.
Site Strategy
- Use EHR/claims heatmaps to pick regions with high disease burden and underrepresented populations.
- Balance academic centers with Federally Qualified Health Centers, safety-net hospitals, and community clinics.
- Pre-contract readiness: share computable phenotypes, prescreen lists, and outreach scripts before site initiation visit (SIV).
- Appropriately resource sites: fund patient navigators or part-time recruiters; define micro-service level agreements (e.g., referral to contact <72h).
- Limit low-performing sites; shift activation to proven performers; avoid oversaturating competing geographies.
- Set site performance metrics: time-to-first-patient ≤60 days post-SIV, minimum enrollments/site/month.
- Align site hours with patient schedules (evenings/weekends).
Patient Outreach and Access
- Partner with community venues (churches, barbershops, pharmacies) for education and referrals.
- Deploy community health workers (CHWs) to provide trial navigation, education, and follow-up.
- Implement multi-channel outreach from centralized prescreening (SMS, email, phone, letters).
- Offer transportation, parking vouchers, rideshare, and provide childcare/meal stipends as needed.
- Create bilingual, culturally tailored recruitment scripts, not just materials, with a clear value proposition and visuals.
- Use mobile trial units or pop-up clinics in rural and underserved communities.
Consent and Onboarding
- Use a single, plain-language overview sheet plus detailed consent; confirm understanding via teach-back.
- Provide a ‘first-visit concierge’: step-by-step logistics, maps, contacts, what-to-expect video.
- Set up an automated reminder system (SMS/phone/email) for visits, labs, and diaries.
- Enroll caregivers where relevant (e.g., heart failure/chronic kidney disease) and support their needs.
Retention and Engagement
- Offer flexible scheduling and rescheduling without penalty; include a missed-visit recovery plan.
- Maintain regular check-ins between visits (via CHWs, coordinators, or digital engagement tools).
- Provide home or near-home alternatives for burdensome procedures when feasible.
- Return individual results (labs, vitals) and periodic study updates/newsletters.
- Implement patient engagement platforms (apps, text check-ins, push notifications) for ongoing connection.
- Leverage peer-to-peer patient ambassadors or advocacy group liaisons for trust-building and support.
- Conduct exit interviews among withdrawing participants to capture learnings and adapt practices.
- Use a retention-risk flag system (transport, work hours, childcare) at screening with documented mitigation steps.
- Provide consistent, transparent reimbursement, paid via participant-preferred method.
Data, Technology, and Metrics
- Establish a sponsor-run, IRB-approved centralized EHR prescreening hub.
- Define and track funnel metrics: outreach→contact→prequal→screen→randomize; by site and subgroup.
- Monitor representativeness weekly (sex, race/ethnicity, age, rurality) and trigger remediation plans.
- Publish site scorecards (time-to-first-patient, enrollment rate, screen fail %, retention).
- Ensure privacy/security controls for all electronic systems and participant data (ICH E6[R3]).
- Document essential records and validation for computerized systems.
At Alliance Clinical Network, we believe successful cardiometabolic trials require more than great science; they demand removing the barriers that prevent patients from enrolling and staying engaged. Contact us today and learn how we can help you achieve your recruitment and retention goals.
