Industry News: JumpStart! - Modernizing the Drug Review ProcessThe JumpStart service is a new Food and Drug Standards (FDA) initiative aimed at 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.
This new initiative was recognized in May 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. Managing Applications Growing in Number and Complexity
In 2010, the CDER Data Standards Program
was established “to identify and prioritize data standards needs and to implement good practices for standards development.” As the workload at CDER continues to increase, the use of standardized data, tools intended to perform analyses
on standardized data, and supportive services become critical to the effective management and completion of New Drug Applications (NDAs) and Biologic License Applications (BLAs) reviews. JumpStart
was created to work in alignment with the CDER's Review Process and with evolving regulatory
science, to manage the increase in number and complexity of applications. With more clinical trial
data being submitted in a standardized format the creation of this integrated review environment that partitions work enables data experts to focus on data fitness and exploratory safety analyses. Reviewers’ can now focus on applying their clinical and scientific expertise to analyze study data for completing these NDA and BLA reviews.Implementing Standardized Data for Analyses
The FDA houses the largest known repository of clinical trial data, including unique high-quality data on the safety, effectiveness, and performance of drugs and biologics, both pre- and post-approval. When these data are not collected or stored in a standardized format, it is difficult to perform various required analyses during the scientific regulatory review process. 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.
For more information on this new FDA initiative please view the FDA’s JumpStart