دورية أكاديمية
Improving access to cancer clinical research in Brazil: recent advances and new opportunities. Expert opinions from the 4th CURA meeting, São Paulo, 2023.
العنوان: | Improving access to cancer clinical research in Brazil: recent advances and new opportunities. Expert opinions from the 4th CURA meeting, São Paulo, 2023. |
---|---|
المؤلفون: | Resende H; Instituto Projeto Cura, São Paulo 05507-020, SP, Brazil.; https://orcid.org/0000-0003-4692-3743., Arai RJ; Independent Clinical Researcher, São Paulo 01153-000, SP, Brazil.; https://orcid.org/0000-0001-5617-1042., Barrios CH; Latin American Cooperative Oncology Group (LACOG), Porto Alegre 90619-900, RS, Brazil.; https://orcid.org/0000-0001-6021-667X., Schwyter F; Instituto Projeto Cura, São Paulo 05507-020, SP, Brazil., Teich NLS; Instituto Teich de Políticas Públicas em Saúde, Rio de Janeiro 22640-102, RJ, Brazil.; https://orcid.org/0000-0003-1352-1334., Gomes A; Bristol Myers Squibb, São Paulo 04719-002, SP, Brazil., Dallari AB; Independent Lawyer, São Paulo 01153-000, SP, Brazil., Bonilha LAS; Comissão Nacional de Ética em Pesquisa (CONEP), Brasília 70719-040, DF, Brazil., Souza CMA; Agência Nacional de Vigilância Sanitária - Anvisa, Brasília 71205-050, DF, Brazil., Francisco FR; Associação Brasileira de Organizações Representativas de Pesquisa Clínica- Abracro, São Paulo 01311-902, SP, Brazil., Munhoz RR; Hospital Sírio Libanês, São Paulo 01308-050, SP, Brazil.; https://orcid.org/0000-0001-8898-2798., Werutsky G; Latin American Cooperative Oncology Group (LACOG), Porto Alegre 90619-900, RS, Brazil.; https://orcid.org/0000-0001-6271-105X., Madi M; Sociedade Brasileira de Oncologia Clínica (SBOC), São Paulo 01311-300, SP, Brazil.; https://orcid.org/0000-0003-1049-4932., Fernandes P; Associação Brasileira de Organizações Representativas de Pesquisa Clínica- Abracro, São Paulo 01311-902, SP, Brazil.; Sail for Health, São Paulo 04543-011, SP, Brazil., Figueiredo JM; Instituto do Câncer Brasil, Taubaté 12030-200, SP, Brazil., Fedozzi F; Associação Brasileira de Linfoma e Leucemia, ABRALE, São Paulo 05423-040, SP, Brazil., Arruda L; Hospital São Camilo, São Paulo 05022-001, SP, Brazil.; https://orcid.org/0000-0002-7101-4325., Aguiar VQ; Centro Universitário de Volta Redonda - UNIFOA, Volta Redonda 27240-560, RJ, Brazil.; https://orcid.org/0000-0002-6257-0119., Melo AC; Brazilian National Cancer Institute (INCA), Division of Clinical Research and Technological Development, Rio de Janeiro 20230-130, RJ, Brazil.; https://orcid.org/0000-0002-1201-4333. |
المصدر: | Ecancermedicalscience [Ecancermedicalscience] 2024 Apr 18; Vol. 18, pp. 1698. Date of Electronic Publication: 2024 Apr 18 (Print Publication: 2024). |
نوع المنشور: | Journal Article |
اللغة: | English |
بيانات الدورية: | Publisher: ecancer Country of Publication: England NLM ID: 101392236 Publication Model: eCollection Cited Medium: Print ISSN: 1754-6605 (Print) Linking ISSN: 17546605 NLM ISO Abbreviation: Ecancermedicalscience Subsets: PubMed not MEDLINE |
أسماء مطبوعة: | Publication: Bristol, UK : ecancer Original Publication: Bristol, UK : Cancer Intelligence |
مستخلص: | Clinical research is the cornerstone of improvements in cancer care. However, it has been conducted predominantly in high-income countries with few clinical trials available in Brazil and other low-and-middle-income countries (LMIC). Of note, less than one-third of registered clinical trials addressing some of the most commonly diagnosed cancers (breast, lung and cervical) recruited patients from LMIC in the last years. The Institute Project CURA promoted the fourth CURA meeting, discussing barriers to cancer clinical research and proposing potential solutions. A meeting was held in São Paulo, Brazil, in June 2023 with representatives from different sectors: Brazilian Health Regulatory Agency (Anvisa), National Commission of Ethics in Research (CONEP), non-governmental organisations, such as the Latin American Cooperative Oncology Group, the Brazilian Society of Clinical Oncology (SBOC), Contract Research Organisations, pharmaceutical companies and investigators. A total of 16 experts pointed out achievements as shortening the time of regulatory processes involving Anvisa and CONEP, development of staff training programs, maintenance of the National Program of Oncological Attention (PRONON), and the foundation of qualified centres in North and Northeast Brazilian regions. Participants also highlighted the need to be more competitive in the field, which requires optimising ongoing policies and implementing new strategies as decentralisation of clinical research centres, public awareness campaigns, community-centered approaches, collaborations and partnerships, expansion of physicians-directed policies, exploring the role of the steering committee. Active and consistent reporting of the initiatives might help to propagate ongoing advances, increasing Brazilian participation in clinical cancer research. Engagement of all players is crucial to maintain continuous progress with further improvements in critical points including regulatory timelines and increments in qualified human resources which aligned with new educational initiatives focused on physicians and the general population will expand access to cancer clinical trials in Brazil. Competing Interests: Heloisa Resende has received research funding from Novartis and Roche, all outside the scope of this manuscript. Gustavo Werutsky has received research funding from AstraZeneca/MedImmune, Bristol-Myers Squibb Brazil, Pfizer, Roche and Roche/Genentech, all outside the scope of this manuscript. Has consulting or advisory role at Merck. Carlos H Barrios has received research funding from AB Science, Abbvie, Abraxis BioScience, Amgen, Asana Biosciences, Astellas Pharma, AstraZeneca, Biomarin, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Clinica Atlantis, Covance, Daiichi Sankyo, Exelixis, GlaxoSmith-Kline, Halozyme, ImClone Systems, INC Research, inVentiv Health, Janssen, LEO Pharma, Lilly, Medivation, Merck, Merck KGaA, Merrimack, Millennium, Mylan, Novartis, Pfizer, PharmaMar, Polyphor, Roche/Genentech, Sanofi, Shanghai Henlius Biotech and Taiho Pharmaceutical, all outside the scope of this manuscript. Has consulting or advisory role at AstraZeneca, Boehringer Ingelheim, Eisai, GlaxoSmithKline, Libbs, Lilly, MSD Oncology, Novartis, Pfizer, Roche/Genentech and United Medical. Has stock and other ownership interests in MedSIR and Tummi. All other authors have no conflicts of interest to disclose. (© the authors; licensee ecancermedicalscience.) |
References: | Nat Rev Clin Oncol. 2023 Jan;20(1):7-15. (PMID: 36380066) JAMA Oncol. 2021 Mar 01;7(3):379-385. (PMID: 33507236) Curr Oncol. 2023 Jan 04;30(1):653-662. (PMID: 36661699) Contemp Clin Trials Commun. 2020 Sep;19:100637. (PMID: 32835128) Lancet Reg Health Am. 2021 Dec 23;7:100153. (PMID: 36777653) J Natl Cancer Inst. 2021 Mar 1;113(3):244-257. (PMID: 33022716) Oncologist. 2019 Aug;24(8):e709-e719. (PMID: 30910864) N Engl J Med. 2022 Jan 20;386(3):203-205. (PMID: 35029846) Ecancermedicalscience. 2023 Nov 23;17:1640. (PMID: 38414936) Cell Stress Chaperones. 2017 Nov;22(6):847-852. (PMID: 28584930) Am Soc Clin Oncol Educ Book. 2022 Apr;42:1-11. (PMID: 35561304) J Clin Oncol. 2017 Nov 20;35(33):3737-3744. (PMID: 28968170) Clinics (Sao Paulo). 2018 Sep 21;73(suppl 1):e515s. (PMID: 30281697) Int J Equity Health. 2023 Feb 2;22(1):25. (PMID: 36732749) Nat Med. 2022 Apr;28(4):649-657. (PMID: 35440716) J Oncol Pract. 2018 Jan;14(1):e1-e10. (PMID: 29099678) J Clin Oncol. 2022 Jul 1;40(19):2163-2171. (PMID: 35588469) World Health Organ Tech Rep Ser. 2003;908:i-viii, 1-136, back cover. (PMID: 12768889) CA Cancer J Clin. 2021 May;71(3):209-249. (PMID: 33538338) J Clin Oncol. 2008 Nov 20;26(33):5458-64. (PMID: 18955452) Am Soc Clin Oncol Educ Book. 2019 Jan;39:176-184. (PMID: 31099620) Am Soc Clin Oncol Educ Book. 2021 Mar;41:1-9. (PMID: 33793310) ESMO Open. 2016 Jun 17;1(4):e000055. (PMID: 27843620) |
فهرسة مساهمة: | Keywords: cancer; clinical trials; low- and middle-income countries |
تواريخ الأحداث: | Date Created: 20240522 Latest Revision: 20240523 |
رمز التحديث: | 20240523 |
مُعرف محوري في PubMed: | PMC11108048 |
DOI: | 10.3332/ecancer.2024.1698 |
PMID: | 38774565 |
قاعدة البيانات: | MEDLINE |
تدمد: | 1754-6605 |
---|---|
DOI: | 10.3332/ecancer.2024.1698 |