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# Stakeholder Input on Innovative Trial Workshop
- URL: https://www.fdaweb.com/stakeholder-input-on-innovative-trial-workshop/
- Published: 2024-01-24T12:00:00.000Z
- Updated: 2026-09-14T14:21:07.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156201

Pharmaceutical Research and Manufacturers of America (PhRMA) says it supports the expanded use of innovative clinical trial approaches since they offer the potential for more patient-focused, efficient, timely, and targeted product development to support regulatory decision-making. Responding to an FDA call for comments on an upcoming workshop on “Enhancing Adoption of Innovative Clinical Trial Approaches,” PhRMA [says](https://www.regulations.gov/comment/FDA-2023-N-4489-0026?ref=fdaweb.com) it would be helpful if there were greater consistency across the agency in individual review divisions’ willingness to discuss or accept innovative approaches. “More detailed advice from FDA to sponsors around what data would be required to support approval of applications for products utilizing innovative approaches would be helpful,” it says.

The comment letter also includes the association’s responses to specific pre-workshop questions raised by the agency.

In its [response](https://www.regulations.gov/comment/FDA-2023-N-4489-0022?ref=fdaweb.com), the Biotechnology Innovation Organization (BIO) says it is important to reach global alignment on protocols to allow for global protocols. “FDA’s role as a leader in innovative clinical trials puts them in a position to be working globally with health authorities so that there is understanding across the globe about what innovative clinical trial approaches are acceptable,” BIO says.

The Real-World Evidence Alliance [provided](https://www.regulations.gov/comment/FDA-2023-N-4489-0020?ref=fdaweb.com) these specific comments for FDA to consider discussing at the workshop:

- the value of real-world data/evidence in drug development and clinical trials; and
- barriers to using real-world data/evidence.

Parexel, a clinical research organization, [calls](https://www.regulations.gov/comment/FDA-2023-N-4489-0014?ref=fdaweb.com) for FDA to lead a breakthrough project that can serve as an example for the clinical trial community. “With the breakthrough project,” it says, “the clinical trial community can see this as a precedent and strongly consider innovative methods (whereas now the dominant paradigm is relying on methods that are ‘established,’ ‘proven,’ and ‘conservative.’” Parexel says it shares FDA’s optimism that progress is possible and anticipates that early breakthrough projects will rapidly precipitate adoption.

Finally, Lilly offered these general [comments](https://www.regulations.gov/comment/FDA-2023-N-4489-0010?ref=fdaweb.com):

- using lessons learned from the pandemic, develop a shared vision for the modernization of clinical trials based on a risk-based framework across all therapeutic areas;
- use decentralized clinical trials to increase diversity in clinical trials, and improve research efficiency;
- modernize the regulatory framework for digital health technologies; and
- promote the development and adoption of innovative statistical approaches.