You’ve probably heard of JumpStart by now. The FDA is describing it as a “service [that] is modernizing the drug review process.” But how, and why? And how can the pharmaceutical and biotech industries benefit from it?
One of the big drivers of this change was time. Currently, when the FDA receives a submission, reviewers spend up to 45 days just to assess the quality of that submission. They have to first churn through enormous files — some of which are gigabytes in size — to determine if the data quality and content are strong enough to support the review. Between the time spent by the FDA to conduct this “pre-review,” and the time spent by the submitting organization to fix these issues and resubmit, valuable months are often wasted.
JumpStart was created to simplify and fast-track this process. JumpStart conducts a series of data fitness assessments and exploratory analyses early in the review process — to assess data composition, quality, safety signal identification, risk analyses and more — so reviewers better understand the data, and have the information needed to conduct an effective evaluation of the drug submission. By leveraging the right technologies to make this happen, these assessments and analyses are completed and their findings are provided within 2 weeks of the receipt of a new submission. This gives reviewers ample time to clarify issues or make requests of the submitting organization before proceeding in the review process.
At a high level, JumpStart helps reviewers:
- Assess clinical trial data quality
- Determine what types of analyses can be performed and what review tools can be used
- Identify where there are gaps or inconsistencies in the data that may have an impact on the review
We believe this benefits submitting organizations by:
- Addressing potential data-fitness issues early on in the review cycle, to expedite the process and avoid delays
- Encouraging collaboration and communication among different disciplines and informatics experts, to efficiently resolve data issues or questions
- Streamlining the data-fitness hurdles through modern tools and technologies, and exposing more people to these technical innovations
- Taking a major step toward standardizing all clinical trial data housed at FDA via CDISC standards
The new technologies driving JumpStart — including DataFit, which is a custom implementation of Pinnacle 21's OpenCDISC Enterprise platform — were put in place by the FDA to help support its push for high quality standardized data. Times are changing, and the FDA is making it clear: future submissions seeking FDA approval will be required to have high-quality, CDISC-compliant data. Fortunately, new processes like JumpStart and new technologies like OpenCDISC Enterprise can give you that confidence in your data … and enable the review process to run as smoothly and quickly as possible.