Vaccine trials often pose unique challenges not typically faced by other therapeutic areas in clinical research. PRA’s Melissa Bishop explains.
Subject enrollment is often accelerated, and start-up activities must begin much earlier than in non-vaccine studies. Because vaccines are often developed in response to a new threat or epidemic -- such as Zika, for example -- there is not always sufficient time to plan extensive timelines in getting the first site ready for screening and enrollment. The trial may also have imminent submissions for approval as well as the need to determine safety and efficacy early on and at specific time-points to decide whether the study should be halted or continue.
Adequate resourcing across all team members must be secured immediately. Clinical development teams must collaborate very quickly upon learning of a new study start-up and proactively develop timeline scenarios to mitigate risks associated with delayed site openings and first vaccination. Can extra full- or part-time employees be included in the budget and utilized for a particular area? Should the study be given any particular prioritization over other ongoing study builds?
Logistics must be sorted out. Decisions regarding protocol development, systems, and procurement of appropriate vendors must also be made. Contracts and agreements may require early drafting. Explicit Standard Operating Procedures and other applicable process documents should be utilized and govern all aspects of the study planning phase to ensure the most efficacious and accurate roll-out of the study.
Steps to success
- Kick-off and frequent recurring team meetings are key to understanding and developing all of the database specifications, site enrollment operations, study medication production and shipment, as well as milestone timing expectations of the sponsor. Usual durations for specific build activities may need to be reduced in order to meet the start-up deliverables and extra work hours may be needed by some or all functional areas to meet the timelines. Alignment with external vendors and study resources must be reviewed continuously during this time.
- Team members should review and assess issues as soon as they arise and determine root cause in order to develop an action plan for resolution. Milestones should be reassessed if delays have accrued, and reductions determined to help decrease time lost.
- Appropriate buffers should be included in the study schedule upfront to account for unforeseen circumstances. If downstream start-up activity timing cannot be decreased due to resourcing or risk of accuracy, the timing should be re-projected to both optimistic and conservative scenarios to get back on track with the most feasible milestone achievement.
- Any changes to the roll-out milestone must be conveyed not only internally with the sponsor, but with applicable vendors as necessary and all resources and their management among functional areas as well as field personnel such as CRAs and site staff. At the same time, any new timing issues or conflicts such as holidays, resource allotment and potential subject enrollment issues at the sites due to delay or extension of study timelines must be considered.
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