P111: Using a Quality Improvement Collaborative Methodology to Improve Pediatric Research Site Processes
Director, Site Network, Quality Improvement
The Institute For Advanced Clinical Trials For Children. United States
Introduce an innovative approach to improving the conduct of pediatric clinical trails, by creating a clinical research learning network to transform the clinical research processes, so that more safe and effective therapeutic interventions are available sooner for children in need.
Introduce an innovative approach to improving the conduct of pediatric clinical trials, by creating a clinical research learning network designed to optimize the clinical research processes, so that more safe and effective therapeutic interventions are available sooner for children in need.
In 2021, 40 sites committed to collecting baseline data on the clinical research process, although only 65% of those sites were able to collect data on at least one pediatric clinical trial. Data were collected on 260 pharmaceutical sponsored trials. Ten outcome measures were identified from mapping the clinical research process. The table summarizes the results from several different start up measures.
Measures Average (days) Range (days) # Studies
1.1 Time from Receipt of Study Start-Up Packet to SIV 151 23 -310 75
1.2 Time from Receipt of Budget to Final Budget Approval 99 3 -309 120
1.3 Time from Receipt of Contract to Final Contract Approval 126 2 -393 112
1.4 Time from First Ancillary Protocol Review Sent to Final Ancillary Protocol Review Received 29 1 -368 157
1.5 Time from Submission of Initial IRB Application to Final IRB Approval 42 1 -178 105
1.6 Time from Receipt of Study Start-Up Packet to Final IRB Approval 144 days 22 -358 109
The data revealed a wider variation across sites for a few measures, while other measures exhibited a smaller range of variation. The average time from study start up to site initiation was 151 days (range 23-310 days). There was also a wide variation in the contracts and budget process.. Completing the budget process ranged from 3 to 309 days. Completing the research contract ranged from 2 to 393 days There was less variation around ancillary reviews and IRB submissions timelines. Even with a smaller variation, some sites had faster turnaround than others.
We successfully built a pediatric clinical research learning network, the major goal of which was to help optimize the clinical research process. We created an infrastructure that enabled multiple centers across the U.S. to track multiple measures of study start-up time. Although 2021 focus was collecting baseline data, lessons were learned. Significant variation was observed among the participating sites in many of the study start-up process metrics. It is conceivable that sites with lower average time have discovered methods or processes for achieving faster turnaround times. There are some sites with significantly longer study start-up timelines. In both circumstances, participation within the learning network offers the perfect avenue for sites to glean from one another improve upon their clinical trial processes, and ultimately, have an impact on and save children’s lives. These are sites are prime candidates to take advantage of the learning network to identify and adopt best practices and shared successes; they also can share challenges and lessons learned with other sites to help keep others from emulating their mistakes. It is imperative that sites collect data to assist them in identifying challenges or bottlenecks for which further optimization could be performed. Overall, sites are motivated for improvement, but currently may not have a culture that supports the work. Identified barriers to participation were lack of leadership support and impacts of COVID 19. (Ironically, COVID has taught the industry that clinical trials can be conducted more efficiently and faster.) Sites need support in building a culture of quality improvement into their daily work, while managing competing priorities. In recognition of the fact that data collection is burdensome but necessary, revisions to the data collection process are underway, to both reduce the burden of collecting data and to increase the number studies in the database.