Significant delays exist in industry-sponsored pediatric clinical drug trial start-up and enrollment processes

Abstract

Background

Significant barriers to advancing pediatric drug development continue despite federal incentives to expedite pediatric drug development. There is an urgent need to improve how clinical trials are designed, implemented, and conducted to increase the number of approved therapeutic interventions for children.

Methods

The Pediatric Improvement Collaborative for Clinical Trials & Research was created to measure timelines and address delays in the pediatric clinical trials process. This multi-site collaborative prospectively monitored sixteen time points in industry-sponsored pediatric clinical drug trials, including times to budget approval, contract execution, ancillary protocol review, Institutional Review Board approval, Site Initiation Visit, and first patient consented.

Results

Twenty-four sites contributed data on 330 industry-sponsored pediatric drug studies. The average duration to final study budget approval was 121 (range 3–585) days, to final study Institutional Review Board (IRB) approval was 51 (range 1–205) days, to Site Initiation Visit was 204 (range 23–600) days, and to first patient consented was 239 (range 30–534) days.

Conclusion

Significant study start-up delays were noted in industry-sponsored clinical drug trials among a large group of pediatric sites. Delays and wide variation in all steps of the study process indicate multiple opportunities for improvement.