Eticidade do uso de placebo em pesquisa clínica: proposta de algoritmos decisórios

Fregnani, José Humberto Tavares Guerreiro; Carvalho, André Lopes; Paranhos, Flávio Rocha Lima; Viana, Luciano de Souza; Serrano, Sergio; Carcano, F. M.; Ferreira, João Fernando Monteiro; Zier, Sandra Solci; Gontijo, Pollyana Anício Magalhães; Stefanoff, Cláudio Gustavo; França, Paulo Henrique Condeixa de; Bendati, Maria Mercedes de Almeida; Marodin, Gilmar Arduíno Bettio; Venâncio, Jorge Alves de Almeida

doi:10.1590/1983-80422015233082

Cited by 6 publications

(4 citation statements)

References 10 publications

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“…Similar groups in clinical trials contribute to the effect estimates obtained in the studies, being closer to the true result. (32,33) In contrast, it is important to recognize that due to the fact that hemophilia is a low-prevalence disease that directly impacts on patients' health and quality of life, the use of Control Groups using pure placebo is limited. However, in an attempt to minimize biases, increase statistical power, and at the same time not violate ethical principles in human research, small groups could have been crossrandomized into intervention and usual care groups.…”

Section: ❚ Discussionmentioning

confidence: 99%

Quality of clinical studies present in the package inserts of coagulation factors used in the treatment of hemophilia

Araújo¹,

Paolinelli²,

Pichitelli³

et al. 2022

Einstein (São Paulo)

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Objective: To identify and analyze the quality of scientific evidence from clinical efficacy studies present in the package inserts of coagulation factors, used in the treatment of hemophilia A and B. Methods: Documentary study developed in two stages. The first stage consisted of identifying the medicine packages inserts electronically registered in the Brazilian Health Regulatory Agency, and analyzing the availability of the bibliographic references cited therein. This analysis was conducted in the PubMed, SciELO, Google Scholar, and Web of Science databases. The second step was the analysis of the methodological quality of the efficacy studies. Two trained researchers used the Cochrane Collaboration Risk of Bias version 5.1.0 tools for methodological quality analysis, and Review Manager 5.4 software to generate the risk of bias graph. Results: Of the 17 medicines listed, 7 had referenced package inserts. Of these, 10 studies were eligible for analysis of methodological quality. More than half of the analyzed studies did not control for selection, performance, and detection bias. A total of 100% controlled attrition and reporting biases, and 50% had a high risk of conflict of interest. Conclusion:The biases present are significant and may have influenced the overestimation of the effects of the outcomes of each of the studies.

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Section: ❚ Discussionmentioning

confidence: 99%

Quality of clinical studies present in the package inserts of coagulation factors used in the treatment of hemophilia

Araújo¹,

Paolinelli²,

Pichitelli³

et al. 2022

Einstein (São Paulo)

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“…Em relação a essa utilização, existe uma polêmica nos estudos clínicos versus existência de tratamento disponível e, nesse contexto, o membro de CEP deve estar atento aos debates em torno da eticidade de projetos que utilizam placebo, pois durante a análise dos protocolos destas pesquisas, é necessário se certificar se estes estão condizentes com as políticas públicas adotadas pelo Brasil. (23)(24) As normas de boas práticas científicas citadas pelos participantes deste estudo tratam de aspectos relacionados à integridade científica, e às más práticas no contexto científico. (25) A compreensão de boas práticas por membros de CEP é relevante para que eles possam identificar a ocorrência de condutas que contrariam a integridade científica.…”

Section: Métodosunclassified

Fundamentos Para Resolução De Problemas Morais E/Ou Éticos Nos Comitês De Ética Em Pesquisa

Barata¹,

Anjos²,

Ferraz³

et al. 2022

Enfermagem Em Foco

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“…It is also known for its strong opposition against the flexible use of placebo. Both the Federal Council of Medicine and the National Health Council have published resolutions regulating the use of placebo exclusively in clinical trials, preventing their use if there is any effective therapeutic method already in place —although sometimes the interpretation of “effective” by this council is not standard. Likewise, in Uruguay, the current national regulations adhered to the 2000 version of the DOH without taking into account subsequent revisions, which flexibilizes the use of placebo and the best existing treatment in controlled clinical trials (article 29 of the DOH).…”

Section: Latin America Clinical Research Environmentmentioning

confidence: 99%

Personalizing Precision Oncology Clinical Trials in Latin America: An Expert Panel on Challenges and Opportunities

et al. 2019

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The participation of patients in precision oncology trials needs to fulfill molecular‐based selection criteria. This strongly limits accrual, and as a consequence, screening successes have decreased, costs have increased, and fewer subjects are enrolled. To achieve narrowed targets, studies have been forced to be multicenter and multinational to reach a larger pool of candidates. However, this globalization faces many challenges, as, for example, in the case of precision oncology trials. These trials have a complex structure that is dependent upon a high‐tech infrastructure and knowledge in a dynamic environment. Given the movement of precision clinical cancer research to regions other than Europe and the U.S., it is important to evaluate the feasibility of performing such trials in lower‐middle‐ and low‐income countries. Here we critically discuss the advantages of conducting precision oncology clinical trials in Latin America and make suggestions on how to overcome the main challenges involved. Implications for Practice Precision clinical trials in oncology are studies that require candidates to have tumors with specific molecular alterations, which are considered the target for the trial experimental therapy. Because many molecular alterations are rare, fewer patients are enrolled. This has led to trials being forced to be multicenter and multinational, including trials in Latin America. This article discusses the challenges and opportunities to conduct precision oncology trials in Latin America, aiming to help sponsors and investigators to solve complex issues that ultimately lead to more of such trials being run in the region, potentially benefiting more Latin American patients with cancer.

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Eticidade do uso de placebo em pesquisa clínica: proposta de algoritmos decisórios

Cited by 6 publications

References 10 publications

Quality of clinical studies present in the package inserts of coagulation factors used in the treatment of hemophilia

Quality of clinical studies present in the package inserts of coagulation factors used in the treatment of hemophilia

Fundamentos Para Resolução De Problemas Morais E/Ou Éticos Nos Comitês De Ética Em Pesquisa

Personalizing Precision Oncology Clinical Trials in Latin America: An Expert Panel on Challenges and Opportunities

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