• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Drugs

  • Print
  • Share
  • E-mail

JumpStarting Drug Review

JumpStart Logo

 

 

 

 


The JumpStart service is modernizing the drug review process—medical reviewers are using this service to quickly and thoroughly assess data from drug clinical trials, ensuring safe and effective products are approved for public use. 

In May 2014, JumpStart was recognized by the U.S. Health and Human Services (HHS) as a finalist in the HHS Innovates Award Program.  The Projects are listed in the HHS Idea Lab.

 

 

 

What is JumpStart?

JumpStart runs a series of drug clinical trial data analyses early in the review process to assess data composition, quality, analyses options, and tools for the analyses, so reviewers better understand the data and have the information to conduct an effective evaluation of the drug submission.

JumpStart provides these data findings to the reviewers within two weeks of the receipt of a new submission, giving reviewers time to clarify issues or make requests of the organizations developing the drug before proceeding in the review process. JumpStart also provides data analyses that highlight areas of concern and may warrant further attention.

 

JumpStart Benefits and Impact

JumpStart is transforming the scientific regulatory review process in several ways:

  • The JumpStart data fitness assessment and exploratory safety analyses are improving the review process for getting safe and effective drug products to the market.

  • The initial assessment on data fitness gives reviewers and sponsors the opportunity to address potential issues early on in the review cycle and avoid delays.

  • By providing targeted exploratory safety analysis, JumpStart enhances the efficiency of safety signal identification and risk analysis. This has a direct impact on patients who expect the approval of safe and effective products that are appropriately labeled for marketing.

  • JumpStart work session discussions encourage collaboration and communication among different disciplines and informatics experts. By building and enhancing these ties with one another, reviewers and informatics experts can improve and speed communication with sponsors to resolve data issues or questions.

  • JumpStart provides an opportunity for clinical reviewers to take advantage of modern tools and technologies, and expose more people to technical innovation.

 

Wheel diagram with JumpStart in the middle and spokes radiating outward for Data Checks and Suggestions, Analysis Foundation, Outputs and Methodology, Learning moments, Caution and Anomalies, Preliminary Insights, Deep Dive - Click to view larger image.

(Click image to make it larger)