Understanding Clinical Evidence and Risks During Expedited Approval
Expedited approval is a business necessity for companies, especially companies in the ultra-competitive oncology space. With the number of new therapies entering the market, the first entrant wins the market share. Such a competitive race to the top creates an incentive for companies to lean their data gathering to the bare minimum, and to push for additional clinical evidence in a post-approval confirmatory trial.
Written By: Regina Fullin, Vice-President of RA/QA Consulting with Compliance Team
The FDA is beginning to see that this regulatory strategy is fraught with risk and is pushing to crack down on this regulatory loophole, citing one example when it took nine years to complete the confirmatory trial, leaving package insert instructions woefully lacking in product use information, such as interactions with other therapies, and even basics such as the optimal dosing regimen.
FDA investigators and evaluators have the odious task of promoting development of new therapies and balancing new product introductions with the inherent risks of the new products themselves. The FDA is wary of the precedent it has set and is now considering a requirement for design of the follow-up study as a prerequisite for drug approval. If such a requirement were implemented today, the results might be disastrous for existing drug development efforts, extending the time for launch to market, and allowing competitors to fill the market space. Companies attempting to operate quickly and inexpensively, will take risks that could compromise quality and undeservingly take the market share.
What if it didn’t need to be that way? What if a design for follow-up, confirmatory studies could be developed in parallel with execution of existing clinical trials? A skilled Regulatory Affairs Manager and/or Clinical Resource Associate on your team could review the signals incoming from existing clinical data, perform risk assessment to evaluate the areas of high and low risk, and then work with your team to develop a follow-up study plan. The result will translate data into knowledge that will meet or exceed FDA expectations to provide clinicians with the information they need to safely administer products with an on-time product launch.
Whether you need this service, a project manager or simply boots on the ground to get more done to keep your project on schedule, Compliance Team can help you create a customized solution to help you reach your project goals!