LUNGevity Foundation’s Transforming Clinical Trials Initiative (TCTI) develops collaborative strategies to enhance innovation and patient access to safe and effective lung cancer tools and treatments as quickly as possible.
We hope everyone had a positive and fulfilling end of 2025. As highlighted below, LUNGevity Foundation's TCTI had a productive final quarter of the year, hosting part two of our Annual Regulatory Series, taking an active role in Prescription Drug User Fee Act (PDUFA) discussions with the FDA, and focusing on several outputs and presentations to disseminate our work.
As 2026 brings our 10th anniversary of TCTI, 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.
LUNGevity Regulatory Series Part 2 Recap
LUNGevity’s Annual Regulatory Series Part 2 drew over 60 participants—including drug sponsors, U.S. FDA representatives, academic clinicians, and patient advocates—to a snowy Washington, D.C. on December 5th to discuss:
- Evolving thinking regarding dosage optimization
- Progress made to support dosage optimization since Project Optimus
- Challenges that still need collaborative solutions
Actionable solutions and opportunities proposed at the meeting will influence and help shape LUNGevity's working groups and focus areas in 2026.
LUNGevity Submits Comments on FDA Draft Guidance Documents
As part of our work to support the advancement of innovation and access to therapies and diagnostics, LUNGevity provided the following comments on draft guidance documents relevant to the lung cancer community:
- Oncology Therapeutic Radiopharmaceuticals: Dosage Optimization During Clinical Development
- Approaches to Assessment of Overall Survival in Oncology Clinical Trials
Read more about LUNGevity's policy priorities and previous comment letters.
Patient-Focused Drug Development Final Guidance Analysis
The third guidance of the Patient-Focused Drug Development series, Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments, was finalized in October. LUNGevity evaluated modifications from the draft to final guidance, in light of comments made by LUNGevity to the Agency on the draft guidance. The analysis showed several changes reflective of our comments to optimize the incorporation of the patient perspective in drug development.
Read the full analysis on our Policy Perspectives Blog.
Best Practices Guide on Financial Neutrality for Clinical Trial Sites
The Equitable Access to Clinical Trials (EACT) Initiative, hosted by LUNGevity Foundation, released a new resource for cancer clinical trial staff to help mitigate out-of-pocket costs for trial participants: Best Practice Considerations and Recommended Approaches for Clinical Trial Site Staff. This new guide is the latest addition to EACT’s wide breadth of resources available to advance financial neutrality for clinical trial participants.
Read the Best Practices for Trial Site Staff here.
The guide describes out-of-pocket costs in clinical trials and the types of financial support that sites and sponsors can offer clinical trial participants to account for these costs. It also covers tax and legal considerations for compensation, as well as specific tips, tools, and resources for clinical trial site personnel.
Project SignifiCanT: Hybrid Control Arms
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 December 9th on “Statistical Considerations for Hybrid Control Arms in Cancer Clinical Trials.” This discussion among multi-disciplinary experts considered the methodology for constructing hybrid control arms in cancer clinical trials and the statistical challenges and approaches to address these issues.
Participating in PDUFA VIII Consultations
LUNGevity began participation in the Prescription Drug User Fee Act (PDUFA) VIII Public Stakeholder Consultation Series, attending November and December meetings as a recognized patient and consumer advocacy representative. Through these consultations, LUNGevity provides input on priority areas for lung cancer patients and supports discussions on key focus areas for performance goals and statutory sections that will impact drug development.
Meeting summaries from the stakeholder discussions on reauthorization can be accessed here: PDUFA VIII: Fiscal Years 2028 – 2032 | FDA
If you would like to learn more about these and other ongoing TCTI initiatives at LUNGevity and get involved (including work focused on perioperative trial designs, streamlining the schedule of assessments, validation of blood-based lung cancer screening tests, and more) please email [email protected].