دورية أكاديمية
Impact of the COVID-19 Pandemic on Oncology Clinical Research in Latin America (LACOG 0420).
العنوان: | Impact of the COVID-19 Pandemic on Oncology Clinical Research in Latin America (LACOG 0420). |
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المؤلفون: | Lara Gongora AB; Latin American Cooperative Oncology Group (LACOG), Porto Alegre, Brazil.; Hospital Sírio-Libanês, São Paulo, Brazil., Werutsky G; Latin American Cooperative Oncology Group (LACOG), Porto Alegre, Brazil., Jardim DL; Latin American Cooperative Oncology Group (LACOG), Porto Alegre, Brazil.; Hospital Sírio-Libanês, São Paulo, Brazil., Nogueira-Rodrigues A; Latin American Cooperative Oncology Group (LACOG), Porto Alegre, Brazil.; Brazilian Group of Gynecologic Oncology (EVA), Belo Horizonte, Brazil.; Universidade Federal de Minas Gerais, Belo Horizonte, Brazil., Barrios CH; Latin American Cooperative Oncology Group (LACOG), Porto Alegre, Brazil., Mathias C; Latin American Cooperative Oncology Group (LACOG), Porto Alegre, Brazil.; Núcleo de Oncologia da Bahia (NOB)/Oncoclínicas, Salvador, Brazil.; Sociedade Brasileira de Oncologia Clínica (SBOC), São Paulo, Brazil., Maluf F; Hospital Sírio-Libanês, São Paulo, Brazil.; Beneficência Portuguesa de São Paulo, São Paulo, Brazil.; Hospital Israelita Albert Einstein, São Paulo, Brazil., Riechelmann R; A.C. Camargo Cancer Center, São Paulo, Brazil.; Brazilian Gastrointestinal Tumors Group (GTG), Porto Alegre, Brazil., Fraga M; Latin American Cooperative Oncology Group (LACOG), Porto Alegre, Brazil.; Universidade Federal de Santa Maria (UFSM), Santa Maria, Brazil., Gomes H; Latin American Cooperative Oncology Group (LACOG), Porto Alegre, Brazil.; Instituto Nacional de Enfermedades Neoplasicas (INEN), Lima, Peru., William WN; Latin American Cooperative Oncology Group (LACOG), Porto Alegre, Brazil.; Beneficência Portuguesa de São Paulo, São Paulo, Brazil.; Brazilian Group of Thoracic Oncology (GBOT), Porto Alegre, Brazil., Yamada CAF; Latin American Cooperative Oncology Group (LACOG), Porto Alegre, Brazil.; Beneficência Portuguesa de São Paulo, São Paulo, Brazil., de Castro G Jr; Latin American Cooperative Oncology Group (LACOG), Porto Alegre, Brazil.; Hospital Sírio-Libanês, São Paulo, Brazil.; Brazilian Group of Thoracic Oncology (GBOT), Porto Alegre, Brazil.; Instituto do Câncer do Estado de São Paulo (ICESP), São Paulo, Brazil., Rosa DD; Latin American Cooperative Oncology Group (LACOG), Porto Alegre, Brazil.; Brazilian Group of Breast Cancer Studies (GBECAM), Porto Alegre, Brazil.; Hospital Moinhos de Vento, Porto Alegre, Brazil., de Melo AC; Latin American Cooperative Oncology Group (LACOG), Porto Alegre, Brazil.; Brazilian Group of Gynecologic Oncology (EVA), Belo Horizonte, Brazil.; Instituto Nacional de Câncer (INCA), Rio de Janeiro, Brazil., Sala R; Latin American Cooperative Oncology Group (LACOG), Porto Alegre, Brazil.; Grupo Argentino de Investigación Clínica en Oncología, Rosario, Argentina., Bustamante E; Latin American Cooperative Oncology Group (LACOG), Porto Alegre, Brazil.; Chilean Cooperative Group for Oncologic Research (GOCCHI), Santiago, Chile., Bretel D; Latin American Cooperative Oncology Group (LACOG), Porto Alegre, Brazil.; Grupo de Estudios Clínicos Oncológicos Peruano (GECOPERU), Lima, Peru., Arrieta O; Latin American Cooperative Oncology Group (LACOG), Porto Alegre, Brazil.; Instituto Nacional de Cancerología, Ciudad del México, México City, México., Cardona AF; Latin American Cooperative Oncology Group (LACOG), Porto Alegre, Brazil.; Clinical and Translational Oncology Group, Clínica del Country, Bogotá, Colombia., Bastos DA; Latin American Cooperative Oncology Group (LACOG), Porto Alegre, Brazil.; Hospital Sírio-Libanês, São Paulo, Brazil.; Instituto do Câncer do Estado de São Paulo (ICESP), São Paulo, Brazil. |
المصدر: | JCO global oncology [JCO Glob Oncol] 2021 Apr; Vol. 7, pp. 649-658. |
نوع المنشور: | Journal Article |
اللغة: | English |
بيانات الدورية: | Publisher: American Society of Clinical Oncology Country of Publication: United States NLM ID: 101760170 Publication Model: Print Cited Medium: Internet ISSN: 2687-8941 (Electronic) Linking ISSN: 26878941 NLM ISO Abbreviation: JCO Glob Oncol Subsets: MEDLINE |
أسماء مطبوعة: | Original Publication: Alexandria, VA : American Society of Clinical Oncology, [2020]- |
مواضيع طبية MeSH: | COVID-19*, Biomedical Research/*trends , Medical Oncology/*trends, Brazil ; Clinical Trials as Topic ; Cross-Sectional Studies ; Humans ; Latin America/epidemiology ; Pandemics |
مستخلص: | Purpose: COVID-19 has affected cancer care worldwide. Clinical trials are an important alternative for the treatment of oncologic patients, especially in Latin America, where trials can be the only opportunity for some of them to access novel and, sometimes, standard treatments. Methods: This was a cross-sectional study, in which a 22-question survey regarding the impact of the COVID-19 pandemic on oncology clinical trials was sent to 350 representatives of research programs in selected Latin American institutions, members of the Latin American Cooperative Oncology Group. Results: There were 90 research centers participating in the survey, with 70 of them from Brazil. The majority were partly private or fully private (n = 77; 85.6%) and had confirmed COVID-19 cases at the institution (n = 57; 63.3%). Accruals were suspended at least for some studies in 80% (n = 72) of the responses, mostly because of sponsors' decision. Clinical trials' routine was affected by medical visits cancelation, reduction of patients' attendance, reduction of other specialties' availability, and/or alterations on follow-up processes. Formal COVID-19 mitigation policies were adopted in 96.7% of the centers, including remote monitoring and remote site initiation visits, telemedicine visits, reduction of research team workdays or home office, special consent procedures, shipment of oral drugs directly to patients' home, and increase in outpatient diagnostic studies. Importantly, some of these changes were suggested to be part of future oncology clinical trials' routine, particularly the ones regarding remote methods, such as telemedicine. Conclusion: To our knowledge, this was the first survey to evaluate the impact of COVID-19 on Latin American oncology clinical trials. The results are consistent with surveys from other world regions. These findings may endorse improvements in clinical trials' processes and management in the postpandemic period. Competing Interests: Aline B. Lara GongoraHonoraria: MSD Oncology, Amgen Denis L. JardimHonoraria: Janssen-Cilag, Roche/Genentech, Astellas Pharma, MSD Oncology, BMS Brazil, Pfizer, Libbs, MerckConsulting or Advisory Role: Janssen-Cilag, Pfizer, MSDTravel, Accommodations, Expenses: MSD, BMS Brazil, Janssen-Cilag Angelica Nogueira-RodriguesHonoraria: Roche, MSD, AstraZenecaConsulting or Advisory Role: Roche, AstraZeneca, MSD, Eisai Carlos H. BarriosStock and Other Ownership Interests: Biomarker, MedSIR, TummiHonoraria: Novartis, Roche/Genentech, Pfizer, GlaxoSmithKline, Sanofi, Boehringer Ingelheim, Eisai, MSD, Lilly, Bayer, AstraZeneca, Zodiac PharmaConsulting or Advisory Role: Boehringer Ingelheim, Roche/Genentech, Novartis, GlaxoSmithKline, Eisai, Pfizer, AstraZeneca, Libbs, MSD Oncology, United Medical, LillyResearch Funding: Pfizer, Novartis, Amgen, AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Roche/Genentech, Lilly, Sanofi, Taiho Pharmaceutical, Mylan, Merrimack, Merck, AbbVie, Astellas Pharma, Biomarin, Bristol Myers Squibb, Daiichi Sankyo, Abraxis BioScience, AB Science, Asana Biosciences, Medivation, Exelixis, ImClone Systems, LEO Pharma, Millennium, Janssen, Clinica Atlantis, INC Research, Halozyme, Covance, Celgene, inVentiv Health, Merck KGaA, Shanghai Henlius Biotech, Polyphor, PharmaMarTravel, Accommodations, Expenses: Roche/Genentech, Novartis, Pfizer, BMS Brazil, AstraZeneca, MSD Oncology, Lilly Fernando MalufHonoraria: Janssen Oncology, Astellas Pharma, Bayer Schering Pharma, Merck Sharp & Dohme, Roche/Genentech, BMS Brazil, Ipsen, Sanofi/Aventis, Merck Serono, AstraZenecaConsulting or Advisory Role: Janssen Oncology, Astellas Pharma, Bayer Schering Pharma, Merck Sharp & Dohme, Roche/Genentech, BMS Brazil, Ipsen, Merck Serono, AstraZenecaResearch Funding: Janssen-Cilag, Merck Sharp & DohmeTravel, Accommodations, Expenses: Merck Sharp & Dohme, Bayer Schering Pharma Rachel RiechelmannHonoraria: Novartis, Amgen, MSD Oncology, Servier, Roche/GenentechConsulting or Advisory Role: Bayer, Roche/Genentech, Ipsen, Astellas PharmaResearch Funding: Bayer, Roche/Foundation Medicine, Amgen Henry GomesConsulting or Advisory Role: AstraZenecaSpeakers' Bureau: Roche, Novartis, AstraZeneca, Bristol Myers Squibb, LillyResearch Funding: MSD Oncology William N. WilliamHonoraria: Roche/Genentech, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Merck, Lilly, PfizerConsulting or Advisory Role: AstraZeneca, Merck, Pfizer, Bristol Myers Squibb, Bayer, RocheSpeakers' Bureau: Boehringer IngelheimResearch Funding: OSI Pharmaceuticals, Boehringer Ingelheim, Merck, Lilly, Bristol Myers SquibbTravel, Accommodations, Expenses: AstraZeneca, Merck, Bristol Myers Squibb, Roche/Genentech Camilla A. F. YamadaSpeakers' Bureau: Janssen OncologyTravel, Accommodations, Expenses: Bayer, Janssen Gilberto de Castro JuniorHonoraria: AstraZeneca, Pfizer, Merck Sharp & Dohme, Bristol Myers Squibb, Novartis, RocheConsulting or Advisory Role: Boehringer Ingelheim, Pfizer, Bayer, Roche, Merck Sharp & Dohme, Bristol Myers Squibb, AstraZeneca, Yuhan, Merck SeronoSpeakers' Bureau: AstraZeneca, Bayer, Novartis, Roche, Merck Serono, Bristol Myers Squibb, Merck Sharp & Dohme, Boehringer Ingelheim, PfizerTravel, Accommodations, Expenses: Merck Sharp & Dohme, Novartis, Pfizer, Roche, AstraZeneca, Boehringer Ingelheim, Bayer, Bristol Myers Squibb Daniela D. RosaConsulting or Advisory Role: Roche, Novartis, AstraZeneca, Lilly, GlaxoSmithKline, Sanofi, Libbs, Pfizer, Amgen, Zodiac PharmaSpeakers' Bureau: Novartis, Lilly, PfizerTravel, Accommodations, Expenses: Roche Andreia C. de MeloHonoraria: MSD Oncology, Novartis, BMS BrazilSpeakers' Bureau: BMS Brazil, MSD OncologyResearch Funding: Roche, MSD Oncology, BMS Brazil, Novartis, Clovis Oncology, AstraZenecaTravel, Accommodations, Expenses: MSD Oncology Denisse BretelConsulting or Advisory Role: Merck Oscar ArrietaHonoraria: AstraZeneca, Merck Sharp & Dohme, RocheConsulting or Advisory Role: Boehringer Ingelheim, Bristol Myers Squibb, Lilly, PfizerResearch Funding: AstraZeneca, Roche, Merck Sharp & Dohme Andrés F. CardonaHonoraria: Bristol Myers Squibb, Roche, Boehringer Ingelheim, AbbVie, Merck Sharp & Dohme, CelldexConsulting or Advisory Role: Roche, Merck Sharp & Dohme, Novartis, AstraZeneca, Bristol Myers Squibb, Foundation Medicine, Boehringer Ingelheim, Foundation for Clinical and Applied Cancer Research (FICMAC)Speakers' Bureau: Merck Sharp & Dohme, Roche, Bristol Myers Squibb, Novartis, Foundation for Clinical and Applied Cancer Research (FICMAC), Foundation MedicineTravel, Accommodations, Expenses: Merck Sharp & Dohme, Bristol Myers Squibb, Roche, Boehringer Ingelheim, Foundation Medicine Diogo A. BastosHonoraria: MSD, Roche, Bristol Myers Squibb, Janssen-Cilag, Astellas Pharma, AstraZeneca, BayerConsulting or Advisory Role: Roche, Bayer, Janssen-Cilag, MSD OncologyResearch Funding: Janssen-Cilag, Pfizer, Astellas PharmaTravel, Accommodations, Expenses: Janssen-Cilag, BayerNo other potential conflicts of interest were reported. |
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تواريخ الأحداث: | Date Created: 20210506 Date Completed: 20210701 Latest Revision: 20240402 |
رمز التحديث: | 20240402 |
مُعرف محوري في PubMed: | PMC8162498 |
DOI: | 10.1200/GO.20.00663 |
PMID: | 33956499 |
قاعدة البيانات: | MEDLINE |
تدمد: | 2687-8941 |
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DOI: | 10.1200/GO.20.00663 |