Recruitment Predictability
This case highlights how frequent protocol changes between Site Selection and Site Ready stages introduced uncertainty into patient recruitment strategies. These shifts often affected recruitment feasibility, with misalignment typically recognized only after sites struggled to meet targets. The case was resolved using our three-step approach:
Define the challenge with precision.
Problem Statement: Late protocol changes negatively impacted recruitment targets and timelines.
Root cause
- CRAs struggled to effectively discuss inclusion/exclusion criteria and anticipated patient pool during Site Selection.
- CRAs lacked awareness of the need to revisit recruitment feasibility between Site Selection and Site Ready.
Root Cause Learning
- Effective alignment requires detailed understanding of site input to recruitment potential.
- Processes between Site Selection and Site Ready must include checks on recruitment feasibility and strategies as site knowledge and protocol adjustments evolve.
Scope
- Close CRA knowledge gaps in recruitment feasibility assessment.
- Update processes to include recruitment feasibility checks during Site Selection to Site Ready.
Resolution scenario
- Train CRAs in interview and root cause identification techniques.
- Update processes to ensure recruitment feasibility is revisited before Site Ready.
Develop tailored, compliant solutions.
- Create and pilot recruitment workshops with senior CRAs and local Study Managers.
- Update SOPs, trackers, and study team meeting agendas to include recruitment feasibility checks.
Deploy training, oversight, and anchoring.
- Deliver CRA and local Study Manager training.
- Release updated process documentation and monitor adoption during roll-out.
- Anchoring and handover.
- Centrally monitor the validity of recruitment predictability and lessons learned for process adjustments.
- Reinforce process changes via leadership communications and newsletters.
- Capture to inform future compliance initiatives.
- Transition long-term ownership to process owners.
Impact
- Strengthened recruitment predictability by embedding feasibility checks throughout Site Selection to Site Ready.
- Improved CRA capability to translate site input into actionable recruitment strategies.
- Increased alignment between sites and study teams, reducing late recruitment failures.