By: Aman Khera, MBA, FTOPRA, FRAPS – VP, Regulatory Science, Strategy and Innovation
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.
Understanding the Regulatory Landscape
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.
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’s 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 webinar.
The Value of Early & Ongoing Engagement
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.
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.
The Role of Technology and Fast Track Programs
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.
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.
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:
- Planned interactions
- Anticipated regulatory milestones
- Strategies for addressing potential challenges
Global Market Considerations
When considering the global market, you must collectively weigh the added complexity of different regulatory requirements. For instance, the FDA’s Project Orbis facilitates the simultaneous submission and review of oncology drugs among international partners. Establishing solid communication and a good relationship with new individuals and regulatory agencies in different time zones is vital.
Reliance pathways are another mechanism to streamline approvals by leveraging previous stringent intellectual property reviews. Ideally, global regulatory leaders (GRLs) should be part of any company involved in clinical research from the outset, facilitating attention to various requirements and keeping the group updated.
The Vital Role of a Regulatory Clinical Network
A robust regulatory network allows for better information sharing, access to recent trends, and the ability to anticipate potential regulatory push-back by learning from others. Moreover, fostering a healthy regulatory network facilitates “soft intel” through discussions regarding possible changes. Mindful decisions such as attending industry conferences and listening to buzzwords and frequently repeated regulatory phrases can inform likely changes to requirements ahead of time.
Regardless, regulatory agencies expect you to be aware of updates as they happen, so it’s important to have teams dedicated to monitoring regulatory changes. Hiring a regulatory expert and an associated team to manage these components is advisable; due to the volume of information, it would be nearly impossible for one individual to stay afloat.
Importance of Picking an Experienced CRO
One of the major pitfalls in novel development is underestimating the complexities and the number of potential parties that require management. While you may start with an IND application in one country, you might need to file a CTA (Clinical Trial Application) in Europe in other regions. Relying on a trusted CRO with global experience is essential.
By partnering with a CRO, you eliminate the need for external consultants, which adds costs, uncertainty, delays, and additional staffing needs. At Worldwide Clinical Trials, we constantly monitor regulatory changes and fully embrace the need to forge friendly relationships with all local regulatory agencies. By focusing on early and ongoing regulatory engagement, you can more effectively cross the bridge from conception to approval, avoid unnecessary delays, and increase your chances of success.
Be sure to watch our webinar for a full discussion, including a question-and-answer session, and contact us today to discuss your upcoming study!
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- Source: https://www.worldwide.com/blog/2024/06/early-ongoing-regulatory-engagement-for-successful-clinical-trials/