The summer slowdown has not hit LUNGevity’s Transforming Clinical Trials Initiative (TCTI)! We have attended and presented at multiple international conferences, submitted comments to both the FDA and EMA, and are moving forward with advocacy on clinical trial and FDA reform through Prescription Drug User Fee Act (PDUFA) VIII and related potential legislation. Thank you to all our working group members, roundtable participants, and supporters, as you support our mission to improve the efficiency and accessibility of lung cancer clinical research. Continue reading to find out more about our second quarter updates:
LUNGevity Presents at and Attends Several International Conferences
Brittany McKelvey, Senior Director of Regulatory Policy, presented original research from TCTI on the distribution of non-small cell lung cancer early phase clinical trial sites within and outside the United States (read the full white paper here) at the Association for Cancer Research (AACR) Annual Meeting in San Diego in April. Brittany also participated in the Innovations in Drug Review: A Global Perspective panel at the 2026 DIA Global Annual Meeting in Philadelphia in June to provide our perspective on best practices and what may be next for innovating the drug review process, including through PDUFA legislation. Lastly, Tod Guidry, Associate Director of Regulatory and Diagnostics Policy, attended the 33rd Annual Precision Med TRI-CON in San Francisco and provided his perspective on key themes from the meeting.
LUNGevity Submits Comments to FDA and EMA
LUNGevity continues to advocate for patients through commenting on regulatory guidance and requests for information. We provided feedback to the US Food and Drug Administration (FDA) Request for Information and Comments on Advancing the Use of Digital Health Technologies (DHTs) in Clinical Investigations for Drugs and Biological Products. We support the use of DHTs in clinical trials as a powerful means to facilitate access to clinical trials, minimize burdens on trial participants, and advance patient-focused drug development. We also shared comments with the European Medicines Agency (EMA) on their guidance on The Conduct of Clinical Trials During Public Health Emergencies (PHEs). We were concerned by included language prioritizing clinical trials for the medical condition associated with the PHE and the implication that trials for serious conditions should be deprioritized. We encouraged the continued use of a risk-based approach for prioritization of clinical trials.
Discussing Covariate Adjustment in Oncology Clinical Trials: Project SignifiCanT
Project SignifiCanT (Statistics in Cancer Trials), established by the FDA Oncology Center of Excellence, promotes collaboration and engagement among diverse stakeholders in designing and analyzing cancer clinical trials. LUNGevity jointly organized a forum on June 9th on “Covariate Adjustment in Oncology Clinical Trials.” This discussion among multi-disciplinary experts considered the rationale, potential benefits, feasibility, and methodologic and interpretation challenges when utilizing covariate adjustment in cancer clinical trials for regulatory decision-making.
Learnings from the April Oncologic Drugs Advisory Committee (ODAC) Meeting
LUNGevity closely monitors the ever-changing regulatory policy landscape through several avenues, including ODAC discussions, and provides timely perspectives through our Policy Perspectives Blog. Our recent blog focuses on the April 30th ODAC meeting’s major themes, what the meeting’s discussion means for the lung cancer community, and how LUNGevity is addressing these issues. Read our analysis here.
Supporting FDA and Clinical Trial Reform: PDUFA VIII and Related Legislation
In May, LUNGevity held a closed-door virtual roundtable with industry representatives to discuss priorities as the Prescription Drug User Fee Act (PDUFA) VIII package moves to the Hill. We are targeting key Congressional offices for open discussions on opportunities to make needed improvements in the drug development process through the PDUFA package and related legislation. LUNGevity advocates for changes that will ensure the continued delivery of safe and efficacious therapies for patients with lung cancer.
If you would like to learn more about these and other ongoing TCTI initiatives at LUNGevity and get involved, please email [email protected].
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