As we celebrate our 10th anniversary of The Transforming Clinical Trials Initiative (TCTI) in 2026, we look forward to continuing our mission to improve the efficiency and accessibility of lung cancer clinical research. Thank you to all our working group members, roundtable participants, and supporters. Your support drives us forward, ensuring we can collaboratively address pressing challenges and identify actionable solutions for patients with lung cancer. Continue reading to find out more about our first quarter updates:
Save the Date: LUNGevity’s Annual Regulatory Series
LUNGevity is excited to announce the dates for our 2026 Regulatory Series, which will take place on September 18th and December 11th in Washington, D.C. Our series draws drug sponsors, U.S. FDA representatives, clinicians and investigators, and patient advocates to propose actionable solutions to systemic challenges in lung cancer drug development and clinical trials. Registration and roundtable topics will be announced at a later date.
Presenting at the American Association for Cancer Research (AACR) Annual Meeting
Brittany McKelvey, Senior Director of Regulatory Policy, will be presenting original research from TCTI on The Distribution of Non-Small Cell Lung Cancer Early Phase Clinical Trial Sites Within and Outside the United States at the AACR Annual Meeting in San Diego on April 20th. LUNGevity used lung cancer as a use case to assess the distribution of early-phase clinical trial sites within and outside of the US over time to contextualize recent discussions of insufficient enrollment of US patients in oncology trials and US trial site saturation.
LUNGevity Submits Comments on European Medicines Agency (EMA) Reflection Paper
LUNGevity supports the inclusion of patient experience data (PED) in clinical trials across the drug development process, including informing the safety and/or efficacy of new therapies. We therefore provided feedback on EMA’s Reflection Paper on PED, with main themes on additional clarity for the acceptability of methods for achieving a specific goal, promoting alignment across regulatory agencies, and encouraging the use of PED. Read more on our blog detailing LUNGevity’s comments on the EMA reflection paper.
Discussing Re-Randomization in Cancer 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 March 3rd on “Statistical Considerations for Oncology Trials that Include Re-Randomization.” This discussion among multi-disciplinary experts considered the rationale, potential benefits, feasibility, and methodologic and interpretation challenges when implementing re-randomization designs in cancer clinical trials for regulatory decision-making.
Webinar: Advancing Cost Neutrality for Clinical Trial Participants
The Equitable Access to Clinical Trials (EACT) Initiative, supported by LUNGevity Foundation, held a webinar for cancer clinical trial staff discussing site best practices and considerations in providing financial support for clinical trial participants. The webinar recording and slides can be accessed here. This webinar is the latest addition to EACT’s wide breadth of resources available to advance financial neutrality for clinical trial participants.
A Voice for FDA and Clinical Trial Reform: Ongoing PDUFA VIII Negotiations
LUNGevity continues to participate in the Prescription Drug User Fee Act (PDUFA) VIII Public Stakeholder Consultation Series as a recognized patient advocacy representative providing input on priority areas for lung cancer patients. To continue our efforts, we will hold a closed-door virtual roundtable with industry representatives in May to discuss their priorities related to the negotiations. We will also take our own priorities to the Hill and discuss with key Congressional offices opportunities to make needed improvements in the drug development process through the PDUFA package, to 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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