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Table 5 Summary of Themes from the Planning Phase with PIs, Research Teams, and POs/PSs

From: Is this study feasible? Facilitating management of pragmatic trial planning milestones under a phased award funding mechanism

Oversight (Planning Phase)
 PI/Trial Team • Westat and the use of milestones helped with accountability
• Helped the grantees define the milestones
• Encouraged flexibility in interpreting milestones
• Providing documentation was extra work
• Did not have a real need for Westat
• Westat gave unclear guidance
 POs/PSs • Westat’s role relative to the POs was not always clear
• Input from Westat on grantee milestones provided important clarity to help NIH make decision about funding
• Assistance provided by Westat enabled POs to focus on the science
• Independent review process was very well organized
Value of in-person conference
 PI/Trial Team; POs/PSs • Everyone who attended the meeting enjoyed it, found it helpful
• Useful to meet other grantees/hear about their trials
• Felt like a community of pragmatic trialists
• Useful to hear the NIH perspective
 POs/PSs • Useful to hear common description of what pragmatic trials are; everyone on same page
Phased award mechanism
 PI/Trial Team; POs/PSs • Planning phase helpful in showing what works, where problem areas are and what is needed to succeed; good for pilot and feasibility data
 PI/Trial Team • Good, more efficient mechanism for clinical trials; studies with many unknowns
• A way for NIH to be cost-effective
• Provides structure to inexperienced PIs
• Keeps the pace of work up, accountability
• Provides more honest relationship with funding agency
 POs/PSs • Significant involvement of NIH in all decision-making
• Mechanism allowed for PO to serve as liaison between trial team and administrative leadership
• Number of milestones should be comparable across grantees (e.g., no more than 15-20)