The Transforming Clinical Trials Initiative (TCTI) hit the ground running in 2025 to help develop novel solutions to complex challenges in the development of new tools and treatments for lung cancer. Your support drives us forward, ensuring we can collaboratively address pressing challenges and identify actionable solutions.
LUNGevity Welcomes Brittany McKelvey, PhD, as Senior Director of Regulatory Policy
Dr. McKelvey started at LUNGevity in January to direct the Transforming Clinical Trials Initiative. She is energetically leading the organization’s efforts to advance lung cancer policy, clinical trial reform, and regulatory change. Learn More.
Shaping Policy: LUNGevity Submits Comments on FDA Draft Guidance
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the advancement of innovation and access to therapies and diagnostics, LUNGevity provided the following comments on draft guidance documents relevant to the lung cancer community.
- Assessment of Ovarian Toxicity in Premenopausal Adults During Drug Development for Oncologic Products
- Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices
- Expedited Program for Serious Conditions--Accelerated Approval of Drugs and Biologics
- Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway
- Considerations for Including Tissue Biopsies in Clinical Trials; Draft Guidance for Industry, Investigators, Institutions, and Institutional Review Boards
- Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products
Read more about LUNGevity's policy priorities and previous comment letters on our website.
Removing Financial Barriers in Clinical Trials: Establishing Industry Best Practices
The Equitable Access to Clinical Trials (EACT) Initiative just published a commentary in the Journal of Clinical Oncology on the regulatory, logistical, and ethical complexities surrounding financial support for trial participants and actionable pathways forward.
To this end, EACT hosted a webinar on March 5 with experts who discussed various considerations and industry best practices for advancing clinical trial participation and diversity by removing financial barriers for patients.
Project SignifiCanT: Collaborating with the FDA on Perioperative Trial Design
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 the April 8 Project SignifiCanT forum "Design and Analyses Considerations in the Evaluation of Contribution of Effect in Randomized Cancer Clinical Trials." We continue to convene experts on novel perioperative clinical trial designs to inform the assessment of contribution of phase.
Working Group Relaunch: Streamlining Trial Assessments
LUNGevity recently relaunched a working group of expert investigators and industry representatives to encourage the adoption of a more streamlined schedule of assessments in lung cancer clinical trials.
The working group is developing guiding principles and key considerations for reducing unnecessary assessment data collection, particularly in registrational trials for lung cancer treatments with known safety and efficacy profiles (i.e., trials supporting supplemental indications).
Want to get involved? Contact Brittany McKelvey at [email protected].
CRO Roundtable: Tackling Early-Phase Trial Challenges
On April 16, LUNGevity hosted a virtual closed-door roundtable, convening clinical development and regulatory representatives from contract research organizations (CROs) to discuss pressing challenges and potential near-term solutions in lung cancer clinical trials.
The forum focused on recent trends in clinical trial development and operations, including environments to support conduct of early-phase trials in the United States and alleviating site saturation and the burdens associated with activating new trial sites.
We will continue to foster collaborative discussions for further development of solutions to these issues in ongoing LUNGevity work.
If you would like to learn more about TCTI at LUNGevity, please email [email protected]. We'll be at ASCO and would love to connect with you there.
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