{"id":605678,"date":"2024-06-04T14:42:25","date_gmt":"2024-06-04T18:42:25","guid":{"rendered":"https:\/\/platohealth.ai\/the-importance-of-early-and-ongoing-regulatory-engagement-for-successful-clinical-trials\/"},"modified":"2024-06-04T17:18:08","modified_gmt":"2024-06-04T21:18:08","slug":"the-importance-of-early-and-ongoing-regulatory-engagement-for-successful-clinical-trials","status":"publish","type":"post","link":"https:\/\/platohealth.ai\/the-importance-of-early-and-ongoing-regulatory-engagement-for-successful-clinical-trials\/","title":{"rendered":"The Importance of Early and Ongoing Regulatory Engagement for Successful Clinical Trials","gt_translate_keys":[{"key":"rendered","format":"text"}]},"content":{"rendered":"
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By: Aman Khera, MBA, FTOPRA, FRAPS \u2013 VP, Regulatory Science, Strategy and Innovation<\/p>\n

Are you fully aware of how big a difference early and continued regulatory engagement can make for your clinical trial success and beyond? Regulatory requirements are constantly changing and frequently so complex that managing them requires dedicated cross-functional teams with the highest caliber of regulatory expertise.<\/p>\n

Understanding the Regulatory Landscape<\/strong><\/p>\n

Regulatory requirements are constantly evolving, making it essential for regulatory and clinical trial professionals to stay updated and engaged with regulatory agencies from the outset. This proactive approach helps ensure compliance and builds trust and collaboration with regulatory agencies, which can be invaluable as your project progresses.<\/p>\n

Early and ongoing engagement with relevant regulatory agencies is essential for any therapeutic area or research indication. Waiting until you are about to run a study to ask questions or build rapport can significantly reduce your odds of success. Aman Khera, Worldwide\u2019s VP for regulatory science and innovation, discusses in-depth why this is vital and shares some tricks to optimize your approach. You can hear the whole discussion in our\u202fwebinar<\/a>.<\/p>\n

The Value of Early & Ongoing Engagement<\/strong><\/p>\n

While there are no legal requirements to meet with regulatory agencies like the U.S. FDA, they expect timely responses and providing accurate information. Early engagement allows regulatory agencies to partner and help guide the development process, ensuring alignment with their expectations from the outset. Continued conversations show engagement and foster better odds for approval when the time comes.<\/p>\n

For example, setting up pre-IND (Investigational New Drug) meetings with the FDA can help reshape a clinical trial design to meet efficacy endpoints, avoiding costly revisions down the road. If you are experiencing early toxicology or CMC (Chemistry, Manufacturing, and Controls) issues, meeting with the agency in advance can help you better adapt your design as problems arise.<\/p>\n

The Role of Technology and Fast Track Programs<\/strong><\/p>\n

Advancements in technology and review systems have significantly shortened the timeline for U.S. NDA (New Drug Application) or BLA (Biologics License Application) approvals. Where it used to take between 33 to 36 months, the process is now quicker due to real-time reviews over secure portals. Fast-track programs, particularly for oncology therapeutics, allow for real-time reviews and speedier approvals if aligned with regulatory requirements.<\/p>\n

Ongoing engagement avoids unnecessary delays and increases the chances for approval. Maintaining regular updates ensures ongoing compliance and allows for immediate adaptations to the study, fostering a collaborative relationship between your company and regulatory agencies. This collaboration encourages adjustments to the strategy in response to regulatory feedback, maintaining a positive trajectory for approval.<\/p>\n

In addition, establishing a strategic approach for each development phase and region early on is crucial. We recommend developing a regulatory roadmap that is updated throughout the development journey and includes:<\/p>\n