The Transforming Clinical Trials Initiative aims to define and achieve ideal patient-centric and efficient clinical trials for the development of new tools and treatments for lung cancer.

Since its inception in 2016, LUNGevity’s Transforming Clinical Trials Initiative (TCTI) has leveraged a collaborative approach with multi-stakeholder partners to improve clinical trials.

The Ideal Clinical Trial Paradigm:  

  • Represents the populations the treatment is intended for
  • Is conducted where patients are
  • Reflects what patients want and need
  • Is efficient  
  • Incorporates risks in an appropriate manner 

Achieving the Ideal Clinical Trial Paradigm

We engage global regulators, high-level research experts, clinical leads, industry sponsors, clinical research organizations (CRO), patient advocacy organizations, patients, and government agencies in efforts to advance more efficient drug and diagnostic development.  

Every year, we host two meetings in the Washington, DC, area as part of our Fall Regulatory Series (formerly known as Scientific and Clinical Roundtables). In these meetings, multiple stakeholders gather to address pressing challenges in lung cancer drug development and identify solutions for implementation.

In addition to advancing more efficient clinical trial design and conduct, TCTI encompasses efforts to facilitate patients’ access to clinical trials. Among these is the LUNGevity-hosted Equitable Access to Clinical Trials (EACT) initiative, which convenes stakeholders across the clinical trials ecosystem in efforts to advance financial neutrality for clinical trial participants.

Workstreams

LUNGevity’s TCTI is composed of multiple workstreams and working groups focused on actionable areas across the entire clinical trial life cycle:  

  • Advancing recommendations to expand eligibility criteria for lung cancer trials
  • Streamlining the schedule of assessments
  • Improving the utility of patient-reported outcomes
  • Developing novel trial designs
  • Supporting the validation of emerging diagnostic tests

New workstreams are added as appropriate to tackle the most pressing issues in making clinical trials more patient-centric.

Results to Date: Transforming Clinical Trials Initiative

Financial Neutrality in Clinical Trial Participation

Financial burdens are cited as one of the top reasons patients opt out of clinical trial participation. LUNGevity is a leader in efforts advancing financial neutrality in clinical trial participation, specifically focused on non-medical out-of-pocket costs.

Published Work
  • Barksdale EKS, et al. Financial toxicity in cancer clinical trials: an issue in need of clarity and solutions. JCO. 2025;43:2231-2238. doi:10.1200/JCO-24-01577 

Expanding Eligibility Criteria

Overly restrictive eligibility criteria impede clinical trial enrollment, limit the generalizability of study results to real-world populations, and place hurdles to patient access. LUNGevity leads efforts to encourage the adoption of more inclusive and intentional approaches to setting eligibility criteria in lung cancer clinical trials.

Published Work
  • Gerber DE, et al. A new approach to simplifying and harmonizing cancer clinical trials—standardizing eligibility criteria. JAMA Oncol. 2022;8(9):1333–1339. doi:10.1001/jamaoncol.2022.1664
  • Forde PM, et al. Expanding access to lung cancer clinical trials by reducing the use of restrictive exclusion criteria: perspectives of a multistakeholder working group. Clin Lung Cancer. 2020 Jul;21(4):295-307. doi: 10.1016/j.cllc.2020.02.008
  • Bonomi P, et al. Making lung cancer clinical trials more inclusive: recommendations for expanding eligibility criteria. J Thorac Oncol. 2018;13(6):748-751. doi: 10.1016/j.jtho.2018.02.013

Novel Clinical Trial Designs

The growing complexity of lung cancer treatments introduces complexity in the trial designs needed to adequately assess the safety and efficacy of these treatments in a timely manner. LUNGevity leads multi-stakeholder efforts to identify novel trial designs that are both feasible to conduct and compliant with regulatory expectations.

Published Work
  • Zhang T, et al. Addressing resistance to PD-1/PD-(L)1 pathway inhibition: considerations for combinatorial clinical trial designs. J Immunother Cancer. 2023;11:e006555. doi:10.1136/jitc-2022-006555
  • Waqar SN, et al. Clinician perspectives on current issues in lung cancer drug development. J Thorac Oncol. 2016 Sep;11(9):1387-1396. doi: 10.1016/j.jtho.2016.05.009
     

Patient-Centric Drug Development

The patient voice is a critical component to our efforts to improve the accessibility and efficiency of clinical research. LUNGevity conducts research into patient preferences and advocates for policies that improve patients’ experiences on clinical trials.

Published Work
  • Gerber DE, Barksdale EKS. Approaches to continuing COVID-19–related clinical research practices after the pandemic—must Cinderella leave the ball? JAMA Oncol. 2023;9(8):1027–1028. doi:10.1001/jamaoncol.2023.1514
  • King-Kallimanis BL, et al. Initial steps in creating a patient-centric addendum to clinical trial informed consent forms. JTO Clin Res Rep. 2023 Sept 14;4(10):100575. doi: 10.1016/j.jtocrr.2023.100575
  • Basu Roy U, et al. Learning from patients - reflections on use of patient-reported outcomes in lung cancer trials. J Thorac Oncol. 2018 Dec;13(12):1815-1817. doi: 10.1016/j.jtho.2018.09.003. Epub 2018 Oct 15

Streamlining Clinical Trial Assessments

Data collection in cancer clinical trials has grown exponentially in recent years, placing significant burden on participants and trial site personnel. LUNGevity is leading efforts to streamline the schedule of assessments in lung cancer trial protocols to more closely align with routine clinical practice and reduce burden.

Published Work
  • Bonomi P, et al. Reducing uninformative IND safety reports: a list of serious adverse events anticipated to occur in patients with lung cancer. Ther Innov Regul Sci. 2020 Sep;54(5):1208-1214.
    doi: 10.1007/s43441-020-00145-z

 

Join Our Regulatory Policy Coalition

If you are interested in learning more about or partnering with LUNGevity on TCTI, please reach out to Brittany McKelvey, Senior Director of Regulatory Policy, at [email protected].