Since their inception in 2016, LUNGevity Foundation’s Scientific and Clinical Roundtables (SCRTs) have leveraged its unique structure and multi-stakeholder participants to focus on defining and then achieving ideal patient-centric and efficient clinical trial and therapy development paradigms for lung cancer.
Remote Informed Consent
Using remote informed consent for clinical trial participants could make it easier for patients to enroll in trials. LUNGevity and the National Brain Tumor Society examined remote consent practices at major academic medical centers. Read their findings »
Given the rapidly evolving therapeutic and diagnostic options in lung cancer, clinical trials are often the best treatment choices for patients with lung cancer today. Because of this, it is essential that patients have access to clinical trials and the ability to participate in them.
LUNGevity defines the ideal clinical trial paradigm as inclusive of most patients (mirroring the real world), conducted where patients are, reflective of what patients want and need, efficient, and incorporating risks in an appropriate manner.
To achieve the ideal clinical trial paradigm, LUNGevity's SCRTs convene global regulators, high-level research experts, clinical leads, industry sponsors, CROs, patient advocacy organizations, patients, and government agencies to identify and prioritize opportunities to streamline clinical trials and make them more patient-centric.
SCRTs have multiple workstreams and working groups focused on actionable areas across the entire clinical trial life cycle and are focused on goals such as advancing recommendations to expand eligibility criteria for lung cancer trials, reducing unnecessary and burdensome adverse event reporting, eliminating outdated exclusion criteria, identifying opportunities to leverage prospective synthetic controls, and improving patient-reported outcomes efforts and utility, among others. New workstreams are added as appropriate to tackle the most pressing issues in making clinical trials more patient-centric.
Publications
- Zhang T, Forde PM, Sullivan RJ, Sharon E, Barksdale E, Selig W, Ebbinghaus S, Fusaro G, Gunenc D, Battle D, Burns R, Hurlbert MS, Stewart M, Atkins MB. 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.
- 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
- Gerber DE, Singh H, Larkins E, Ferris A, Forde PM, Selig W, Basu Roy U. 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
- Expanding access to lung cancer clinical trials by reducing the use of restrictive exclusion criteria: perspectives of a multistakeholder working group. 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 Feb 26. pii: S1525-7304(20)30033-4.
- Reducing uninformative IND safety reports: a list of serious adverse events anticipated to occur in patients with lung cancer. Bonomi P, Stuccio N, Delgra CJ, Ferris AE, et al. Ther Innov Regul Sci (2020).
- US Cancer Centers of Excellence Strategies for Increased Inclusion of Racial and Ethnic Minorities in Clinical Trials. Regnante JM, Richie NA, Fashoyin-Aje L, Vichnin M, Ford M, Basu Roy U, Turner K, Hall LL, Gonzalez E, Esnaola N, Clark LT, Adams HC 3rd, Alese OB, Gogineni K, McNeill L, Petereit D, Sargeant I, Dang J, Obasaju C, Highsmith Q, Lee SC, Hoover SC, Williams EL, Chen MS Jr. J Oncol Pract. 2019 Apr;15(4):e289-e299. doi: 10.1200/JOP.18.00638. Epub 2019 Mar 4.
- Making lung cancer clinical trials more inclusive: recommendations for expanding eligibility criteria. Bonomi P, Blumenthal G, Stern Ferris A, 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. - 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.
- Clinician perspectives on current issues in lung cancer drug development. Waqar SN, Bonomi PD, Govindan R, Hirsch FR, Riely GJ, Papadimitrakopoulou V, Kazandjian D, Khozin S, Larkins E, Dickson DJ, Malik S, Horn L, Ferris A, Shaw AT, Jänne PA, Mok TS, Herbst R, Keegan P, Pazdur R, Blumenthal GM. J Thorac Oncol. 2016 Sep;11(9):1387-96. doi: 10.1016/j.jtho.2016.05.009.
If you are interested in learning more about or partnering with LUNGevity on Scientific and Clinical Roundtables, please reach out to Elizabeth Barksdale, Director of Regulatory Affairs and Scientific Policy, at [email protected].