Project Summary

The Food and Drug Administration’s (FDA) “JumpStart” program is modernizing the review process for new drug approvals. FDA medical reviewers are using “JumpStart’s” automated analytics and data-driven tools to more efficiently assess data from clinical trials, helping to ensure safe and effective drugs are approved for public use. This innovation demonstrates the value that data analytics can play in allowing the FDA to more effectively manage complex drug reviews. The “Jumpstart” approach has the potential for application to other areas subject to FDA review.

Project Team

Team Members
Timothy Kropp, FDA
Lilliam Rosario, FDA
Charles Cooper, BD Worldwide
Helena Sviglin, FDA
Patricia Koussis, FDA
DeYett Law, FDA
John Ho, FDA
Joy Li, FDA
Mary Doi, FDA
Eileen Navarro, FDA
Bobbie Witczak, FDA


Project Details

In recent years, new drug applications have been growing in size and complexity. Food and Drug Administration (FDA) scientists and clinicians review clinical trial data to assess their safety and effectiveness. Effective data analysis and support has become critical for evaluating and managing drug reviews. To help keep up with the increasing number of complex drugs review, the FDA’s Center for Drug Evaluation and Research’s Office of Computational Science developed “JumpStart.”

The “JumpStart” program packages tools, technologies, and data assessments to provide FDA reviewers with feedback on the quality, composition, and exploratory safety analyses of clinical trial data at the earliest stage possible. Within the first month of the review process, JumpStart provides this important feedback so reviewers better understand the data and have the information necessary to conduct an effective evaluation. JumpStart helps highlight areas that may warrant further attention and clarifies issues before proceeding with a full review. This allows drug reviewers to spend their time on the substantive aspects of drug review, as opposed to data cleaning or assessing whether the data provided is sufficient for review. The “JumpStart” program is one of many ways FDA is working to continue to protect and promote public health.


Additional Information


Background

HHS Innovates is one of the ways we are building an innovative culture at the Department of Health and Human Services. HHS Innovates is a contest that recognizes and rewards action taken on good ideas. To date, HHS employees have submitted nominations of innovations for nearly 500 exciting new staff-driven innovative projects, and our employees have cast over 60,000 votes to select 42 finalists over seven rounds. This project is one of the finalists of HHS Innovates. Learn more about HHS Innovates.