Access to Clinical Trials

Clinical trials are critical for the development of new therapies for lung cancer.

Recent scientific and drug-development advances have created new opportunities and complexities in today’s lung cancer treatment and research paradigm. This has raised important questions about how best to optimize clinical trial design, patient selection, and regulatory requirements, especially given the rapidly evolving treatment landscape and emerging opportunities with new targeted agents, immunotherapies, and combination approaches.

Scientific and Clinical Roundtables

LUNGevity’s Scientific and Clinical Roundtables bring together key stakeholders from across the lung cancer ecosystem, including domestic and international regulators, industry partners, clinicians, and patients, to discuss challenges and opportunities in designing and executing rational clinical trials and making them more accessible to patients.

The Roundtables provide a platform to prioritize actionable issues and work toward solutions to improve the lung cancer clinical trial landscape for patients, clinicians, drug developers, and regulators, ultimately speeding new treatments to patients faster.

Since 2015, the program has developed and expanded to include several work streams to reform and improve clinical trials. These areas include the following.

Streamlining Clinical Trials

The goal of this Roundtable series is to streamline clinical trials and make them more accessible to patients. The three active work streams include:

  1. Expanding eligibility criteria
  2. Streamlining reporting of suspected unexpected serious adverse reactions (SUSARs) and adverse events
  3. Creating a prospective real-world control arm

Patient-Reported Outcomes

The goal of this Roundtable series is to better gather patient-reported outcomes (PROs) that are meaningful to patients and ensure that the information is communicated to patients in a way that is useful to aid in their decision making. The specific questions being asked include:

  1. Why collect PROs and other patient-experience data in cancer trials?
  2. What PRO concepts should be measured?
  3. How can PROs be best measured?
  4. How can we analyze and communicate this data?

Veteran Enrollment in Clinical Trials

The goal of this Roundtable series is to identify barriers and opportunities to ensure that veterans have access to clinical trials – both standing up more industry trials within the VA Health Care System as well as facilitating veteran access to clinical trials outside of the VA health system. This Roundtable series engages with senior leadership from the Veterans Health Administration, practicing clinicians with the VA, National Association of Veterans’ Research and Education Foundations (NAVREF), and industry partners.

Published/Presented Work

Reducing Uninformative IND Safety Reports: A List of Serious Adverse Events anticipated to Occur in Patients with Lung Cancer
by Bonomi P, Stuccio N, Delgra CJ, Chuk MK, Spira A, Deitz AC, Blumenthal GM, Ferris A, et al.
Ther Innov Regul Sci.
DOI 10.1007/s43441-020-00145-z

Expanding Access to Lung Cancer Clinical Trials by Reducing the Use of Restrictive Exclusion Criteria: Perspectives of a Multistakeholder Working Group
by Forde PM, Bonomi P, Shaw A, Blumenthal GM, Ferris A, Patel C, Melemed A, Basu Roy U, Ramamoorthy A, Liu Q, Burns T, Gainor JF, Lovly C, Piotrowska Z, Lehman J, Selig W
Clin Lung Cancer.
2020; in press.

Making Lung Cancer Clinical Trials More Inclusive: Recommendations for Expanding Eligibility Criteria
by Bonomi P, Blumenthal G, Ferris AS, Stewart DJ, Selig WKD, Krug LM, Allen J, Ison G, Langer CJ, Melemed A, Odogwu L, Basu Roy U, Sandler A
J Thorac Oncol. 2018 Jun;13(6):748-751. doi: 10.1016/j.jtho.2018.02.013.

Learning from Patients: Reflections on Use of Patient-Reported Outcomes in Lung Cancer Trials
by Basu Roy U, King-Kallimanis BL, Kluetz PG, Selig W, Ferris A
J Thorac Oncol
. 2018 Dec;13(12):1815-1817. doi: 10.1016/j.jtho.2018.09.003. Epub 2018 Oct 15.

Securing the cancer continuum of care model for racially and ethnically diverse and medically underserved populations
by Regnante J, Sonet E, Gonzalez E, Winkfield K, Doykos P, on behalf of the cancer continuum of care for racial and ethnic minorities expert working group
Poster presented at AACR, The Science of Cancer Health Disparties in Racial/Ethnic Minorities and the Medically Underserved, Proceedings, Poster D080, Sept 20-23, 2019, San Francisco, CA