TY - JOUR
T1 - Expanding Access to Lung Cancer Clinical Trials by Reducing the Use of Restrictive Exclusion Criteria
T2 - Perspectives of a Multistakeholder Working Group
AU - Forde, Patrick M.
AU - Bonomi, Phil
AU - Shaw, Alice
AU - Blumenthal, Gideon M.
AU - Ferris, Andrea
AU - Patel, Chirag
AU - Melemed, Allen
AU - Basu Roy, Upal
AU - Ramamoorthy, Anuradha
AU - Liu, Qi
AU - Burns, Timothy
AU - Gainor, Justin F.
AU - Lovly, Christine
AU - Piotrowska, Zofia
AU - Lehman, Jonathan
AU - Selig, Wendy
N1 - Funding Information:
P.M.F. reports grants from AstraZeneca, Bristol-Myers Squibb, Kyowa, Novartis, and Corvus and other support from AstraZeneca and Bristol-Myers Squibb, outside the submitted work. J.F.G. reports grants and personal fees from Bristol-Myers Squibb, Genentech/Roche, Takeda, Blueprint, Loxo, Novartis, Merck; personal fees from Oncorus, Regeneron, Pfizer, Incyte, Agios, Amgen, and Ironwood Pharmaceuticals; and grants from Array, Tesaro, Moderna, Adaptimmune, and Alexo, outside the submitted work. A.S. reports personal fees from Blueprint Medicines, KSQ Therapeutics, Bayer, Daiichi-Sankyo, Natera, Taiho, Takeda, Foundation Medicine, Guardant, EMD Serono, Servier, and Chugai; grants and personal fees from Loxo, Ignyta, Pfizer, Novartis, Ariad, TP Therapeutics, and Genentech/Roche; and personal fees and other support from Syros. A.M. is a full-time employee of Eli Lilly and Company. U.B.R. reports research grants from Merck, Celgene, and Boehringer-Ingelheim, outside the submitted work. T.B. reports personal fees from Dava Oncology, ABBVIE, Thermo Fisher, and Novartis, outside the submitted work. C.L. reports consulting fees from Ariad, Takeda, Novartis, Astra Zeneca, Pfizer, Genoptix, Sequenom, Cepheid, Foundation Medicine, Blueprint Medicine, and Achilles Therapeutics and research support (to institution) from Novartis, Astra Zeneca, and Xcovery, outside the submitted work. Z.P. reports consulting fees from AstraZeneca, ImmunoGen, Spectrum, GuardantHealth, Takeda/ARIAD, Novartis, and Genentech and research support (to institution) from AstraZeneca, Novartis, Spectrum, Takeda, and Tesaro, outside the submitted work. J.L. reports other support from Abbvie/Stemcentrx and grants from IPSEN, outside the submitted work. W.S. reports personal fees from LUNGevity Foundation, during the conduct of the study, and unrelated consulting fees in her role as founder and CEO of WSCollaborative, LLC, from Pfizer Oncology, Bayer Oncology, Bristol-Myers Squibb, Seattle Genetics, and TriSalus Lifesciences. The remaining authors declare that they have no competing interests.
Funding Information:
P.M.F. reports grants from AstraZeneca , Bristol-Myers Squibb , Kyowa , Novartis , and Corvus and other support from AstraZeneca and Bristol-Myers Squibb , outside the submitted work. J.F.G. reports grants and personal fees from Bristol-Myers Squibb , Genentech /Roche, Takeda , Blueprint , Loxo , Novartis , Merck; personal fees from Oncorus, Regeneron, Pfizer, Incyte, Agios, Amgen, and Ironwood Pharmaceuticals; and grants from Array , Tesaro , Moderna , Adaptimmune , and Alexo , outside the submitted work. A.S. reports personal fees from Blueprint Medicines, KSQ Therapeutics, Bayer, Daiichi-Sankyo, Natera, Taiho, Takeda, Foundation Medicine, Guardant, EMD Serono, Servier, and Chugai; grants and personal fees from Loxo , Ignyta , Pfizer , Novartis , Ariad , TP Therapeutics , and Genentech /Roche; and personal fees and other support from Syros . A.M. is a full-time employee of Eli Lilly and Company. U.B.R. reports research grants from Merck , Celgene , and Boehringer-Ingelheim , outside the submitted work. T.B. reports personal fees from Dava Oncology, ABBVIE, Thermo Fisher, and Novartis, outside the submitted work. C.L. reports consulting fees from Ariad, Takeda, Novartis, Astra Zeneca, Pfizer, Genoptix, Sequenom, Cepheid, Foundation Medicine, Blueprint Medicine, and Achilles Therapeutics and research support (to institution) from Novartis , Astra Zeneca , and Xcovery , outside the submitted work. Z.P. reports consulting fees from AstraZeneca, ImmunoGen, Spectrum, GuardantHealth, Takeda/ARIAD, Novartis, and Genentech and research support (to institution) from AstraZeneca , Novartis , Spectrum , Takeda , and Tesaro , outside the submitted work. J.L. reports other support from Abbvie /Stemcentrx and grants from IPSEN , outside the submitted work. W.S. reports personal fees from LUNGevity Foundation, during the conduct of the study, and unrelated consulting fees in her role as founder and CEO of WSCollaborative, LLC, from Pfizer Oncology, Bayer Oncology, Bristol-Myers Squibb, Seattle Genetics, and TriSalus Lifesciences. The remaining authors declare that they have no competing interests.
Publisher Copyright:
© 2020 Elsevier Inc.
PY - 2020/7
Y1 - 2020/7
N2 - Low rates of adult patient participation have been a persistent problem in cancer clinical trials and have continued to be a barrier to efficient drug development. The routine use of significant exclusion criteria has contributed to this problem by limiting participation in studies and creating significant clinical differences between the study cohorts and the real-world cancer patient populations. These routine exclusions also unnecessarily restrict opportunities for many patients to access potentially promising new therapies during clinical development. Multiple efforts are underway to broaden eligibility criteria, allowing more patients to enroll in studies and generating more robust data regarding the effect of novel therapies in the population at large. Focusing specifically on lung cancer as an example, a multistakeholder working group empaneled by the LUNGevity Foundation identified 14 restrictive and potentially outdated exclusion criteria that appear frequently in lung cancer clinical trials. As a part of the project, the group evaluated data from multiple recent lung cancer studies to ascertain the extent to which these 14 criteria appeared in study protocols and played a role in excluding patients (screen failures). The present report describes the working group's efforts to limit the use of these routine exclusions and presents clinical justifications for reducing the use of 14 criteria as routine exclusions in lung cancer studies, potentially expanding trial eligibility and improving the generalizability of the results from lung cancer trials.
AB - Low rates of adult patient participation have been a persistent problem in cancer clinical trials and have continued to be a barrier to efficient drug development. The routine use of significant exclusion criteria has contributed to this problem by limiting participation in studies and creating significant clinical differences between the study cohorts and the real-world cancer patient populations. These routine exclusions also unnecessarily restrict opportunities for many patients to access potentially promising new therapies during clinical development. Multiple efforts are underway to broaden eligibility criteria, allowing more patients to enroll in studies and generating more robust data regarding the effect of novel therapies in the population at large. Focusing specifically on lung cancer as an example, a multistakeholder working group empaneled by the LUNGevity Foundation identified 14 restrictive and potentially outdated exclusion criteria that appear frequently in lung cancer clinical trials. As a part of the project, the group evaluated data from multiple recent lung cancer studies to ascertain the extent to which these 14 criteria appeared in study protocols and played a role in excluding patients (screen failures). The present report describes the working group's efforts to limit the use of these routine exclusions and presents clinical justifications for reducing the use of 14 criteria as routine exclusions in lung cancer studies, potentially expanding trial eligibility and improving the generalizability of the results from lung cancer trials.
KW - Cancer clinical trials
KW - Eligibility criteria
KW - Expanded access
KW - Non–small-cell lung cancer
KW - Small-cell lung cancer
UR - http://www.scopus.com/inward/record.url?scp=85082410129&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85082410129&partnerID=8YFLogxK
U2 - 10.1016/j.cllc.2020.02.008
DO - 10.1016/j.cllc.2020.02.008
M3 - Comment/debate
C2 - 32201247
AN - SCOPUS:85082410129
SN - 1525-7304
VL - 21
SP - 295
EP - 307
JO - Clinical lung cancer
JF - Clinical lung cancer
IS - 4
ER -