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# PhRMA Wants More Feedback on Innovative Trials
- URL: https://www.fdaweb.com/phrma-wants-more-feedback-on-innovative-trials/
- Published: 2024-04-19T12:00:00.000Z
- Updated: 2026-09-14T14:28:43.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156815

Pharmaceutical Research and Manufacturers of America (PhRMA) says FDA should hold more meetings on innovative clinical trial approaches. In [comments](https://downloads.regulations.gov/FDA-2023-N-4489-0038/attachment%5F1.pdf?ref=fdaweb.com) submitted to the agency following a workshop last month on such approaches, PhRMA says more discussion would be helpful on model-informed drug development, global harmonization, real-world evidence, novel endpoints, digital health technology-derived endpoints, patient experience data, and specific disease areas and types of trials where barriers to innovation exist.

PhRMA’s comments encourage FDA to take steps to ensure consistency across CDER offices and divisions regarding advice and responses related to innovative clinical trial approaches. There is a need to connect existing “hubs of innovation across CDER’s entire workforce, requiring leadership to instigate change management activities, including steps to incentivize a shift to collaboration across the Center and with sponsors, and incorporate appropriate knowledge management systems and approaches,” the group says. “Consistent information from and communication with agency staff helps to build stakeholder trust, as emphasized during workshop discussions.”

PhRMA says that increased FDA predictability allows development programs to progress more efficiently. “PhRMA appreciates recent CDER efforts to encourage consistency and collaboration among Center staff related to promoting innovative clinical trial approaches,” it says. “In particular, we note the establishment of the CDER Center for Clinical Trial Innovation (C3TI). PhRMA supports C3TI’s goal to serve as a ‘central hub within CDER that supports innovative approaches to clinical trials that are designed to improve the quality and efficiency of drug development and regulatory decision making,’ as described by FDA. PhRMA likewise appreciates CDER’s establishment of the new Quantitative Medicine Center of Excellence (QM CoE). We believe that this new CoE can help to serve as a model for helping to ensure consistency across review divisions and other offices both in and outside CDER.”

Additionally, PhRMA says there is a need for enhanced FDA communication practices with sponsors to help advance innovative trial approaches. “PhRMA member companies would value more frequent opportunities for face-to-face and video conference meetings with agency staff; more consistent FDA responses to sponsor meeting requests; and, to accommodate variable and individual product development timelines, increased flexibility with respect to the timing of informal communications and meetings not subject to user fee goal dates,” the group says. “PhRMA members valued the more frequent dialog opportunities and increased openness to innovation that FDA provided in the context of the Covid-19 pandemic. By adopting a similarly flexible, communicative, and interactive approach to working with sponsors to support the use of situation-appropriate innovative clinical trial approaches, FDA could help mitigate risk aversion related to the use of innovative approaches and encourage their acceptability by reviewers and use by sponsors in clinical development.”