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. 2021 Oct;17(10):607-614.
doi: 10.1200/OP.20.00701. Epub 2021 Feb 3.

Moving Beyond the Momentum: Innovative Approaches to Clinical Trial Implementation

Cathy Eng  1 , Emerson Y Chen  2 , Jane Rogers  3 , Mark Lewis  4 , Jonathan Strosberg  5 , Ramya Thota  4 , Smitha Krishnamurthi  6 , Paul Oberstein  7 , Rang Govindarajan  8 , Gary Buchschacher  9 , Sandip Patel  10 , Davendra Sohal  11 , Taymeyah Al-Toubah  5 , Philip Philip  12 , Arvind Dasari  13 , Hagan Kennecke  14 , Stacey Stein  15
Affiliations

Moving Beyond the Momentum: Innovative Approaches to Clinical Trial Implementation

Cathy Eng et al. JCO Oncol Pract. 2021 Oct.

Abstract

Despite efforts to enhance enrollment and the merger of national cooperative groups, < 5% of patients with cancer will enroll into a clinical trial. Additionally, clinical trials are affected by a lack of diversity inclusive of minority patients, rural residents, or low-income individuals. COVID-19 further exacerbated known barriers of reduced physician-patient interaction, physician availability, trial activation and enrollment, financial resources, and capacity for conducting research. Based on the cumulative insight of academic and community clinical researchers, we have created a white paper identifying existing challenges in clinical trial conduct and have provided specific recommendations of sustainable modifications to improve efficiency in the activation and conduct of clinical trials with an overarching goal of providing improved access and care to our patients with cancer.

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Conflict of interest statement

Cathy EngConsulting or Advisory Role: Bayer Schering Pharma, Foundation Medicine, Array BioPharma, Natera Emerson Y. ChenOther Relationship: Horizon CME, Taiho Pharmaceutical Mark LewisConsulting or Advisory Role: Boehringer IngelheimOther Relationship: Medscape Jonathan StrosbergConsulting or Advisory Role: NovartisSpeakers' Bureau: Ipsen, LexiconResearch Funding: Novartis Ramya ThotaConsulting or Advisory Role: Array BioPharmaResearch Funding: Abbvie, Bristol-Myers Squibb Paul ObersteinConsulting or Advisory Role: Merck, BTG, Tyme, IpsenResearch Funding: Merck, Roche/GenentechTravel, Accommodations, Expenses: Merck Gary BuchschacherResearch Funding: Roche/Genentech, AstraZeneca, MerckTravel, Accommodations, Expenses: Roche/Genentech, AstraZeneca Sandip PatelConsulting or Advisory Role: Bristol-Myers Squibb, AstraZeneca/MedImmune, Nektar, Compugen, IlluminaSpeakers' Bureau: Merck, Boehringer IngelheimResearch Funding: Bristol-Myers Squibb, Pfizer, Roche/Genentech, Amgen, AstraZeneca/MedImmune, Fate Therapeutics, Merck Davendra SohalConsulting or Advisory Role: Perthera, Ability PharmaSpeakers' Bureau: IncyteResearch Funding: Celgene, Genentech, Bristol-Myers Squibb, Rafael Pharmaceuticals, Apexigen, Amgen Philip PhilipHonoraria: Celgene, Bayer, Ipsen, Merck, AstraZeneca, TriSalus Life Sciences, Blueprint Medicines, Syncore, Array BioPharmaConsulting or Advisory Role: Celgene, Ipsen, Merck, TriSalus Life Sciences, Daiichi Sankyo, Syncore, Taiho PharmaceuticalSpeakers' Bureau: Celgene, Bayer, Ipsen, Novartis, IncyteResearch Funding: Bayer, Incyte, Karyopharm Therapeutics, Merck, Taiho Pharmaceutical, Momenta Pharmaceuticals, Novartis, Plexxikon, Immunomedics, Regeneron, Genentech, Tyme, Caris Life Sciences, ASLAN Pharmaceuticals, QED Therapeutics, Halozyme, Boston Biomedical, Advanced Accelerator Applications, Lilly, Merus, QED Therapeutics, Incyte, Caris Life SciencesTravel, Accommodations, Expenses: Rafael Pharmaceuticals, Celgene, AbbVie Arvind DasariConsulting or Advisory Role: Ipsen, Novartis, Voluntis, LexiconResearch Funding: Novartis, Eisai, Hutchison MediPharma, Merck, Guardant Health, Ipsen Hagan KenneckeHonoraria: IpsenResearch Funding: Taiho Pharmaceutical Stacey SteinConsulting or Advisory Role: Genentech/Roche, Eisai, QED Therapeutics, ExelixisNo other potential conflicts of interest were reported.

Figures

FIG 1.
FIG 1.
Example of an EHR research protocol order set validation. EHR, electronic health record.
See this image and copyright information in PMC

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