Uploaded February 2026 | Updated September 2026, 2 weeks ago
Sharon Nachman (Stony Brook University)
https://simons.berkeley.edu/talks/sharon-nachman-stony-brook-university-2026-02-11
Theory of Computing and Healthcare
Background: Clinical trials mature from Phase I to Phase IV. The delay in licensure of new drugs for children and pregnant women is as long as 10 years post licensure for adult populations. Hypothetical use of EMRs for data retrieval along with use of AI to both streamline development of clinical protocols and data sets for submission to FDA and EMA are needed
Methods: Pediatric Investigation Plans (PIP) to EMA and Pediatric Study Plan (PSP) to FDA timing to development of clinical trials suggest long delays. The IMPAACT network protocols and planning will be used to demonstrate gaps in clinical trial and licensure submission
Results: Data from the past 10 years of IMPAACT protocol development to licensure will be presented. Gaps and delays across TB and HIV treatment studies will be discussed focusing on study oversight, interim analyses, trial master files and regulatory submissions.
Conclusions: Lack of creative planning for changes in drug availably and new guidelines suggest that more timely and better alternatives that include AI and EMR tools for clinical trial development are needed.
Sharon Nachman (Stony Brook University)
https://simons.berkeley.edu/talks/sharon-nachman-stony-brook-university-2026-02-11
Theory of Computing and Healthcare
Background: Clinical trials mature from Phase I to Phase IV. The delay in licensure of new drugs for children and pregnant women is as long as 10 years post licensure for adult populations. Hypothetical use of EMRs for data retrieval along with use of AI to both streamline development of clinical protocols and data sets for submission to FDA and EMA are needed
Methods: Pediatric Investigation Plans (PIP) to EMA and Pediatric Study Plan (PSP) to FDA timing to development of clinical trials suggest long delays. The IMPAACT network protocols and planning will be used to demonstrate gaps in clinical trial and licensure submission
Results: Data from the past 10 years of IMPAACT protocol development to licensure will be presented. Gaps and delays across TB and HIV treatment studies will be discussed focusing on study oversight, interim analyses, trial master files and regulatory submissions.
Conclusions: Lack of creative planning for changes in drug availably and new guidelines suggest that more timely and better alternatives that include AI and EMR tools for clinical trial development are needed.
