Douglas Henrique Marin dos Santos | Universidade Federal de São Paulo (UNIFESP) (original) (raw)
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Papers by Douglas Henrique Marin dos Santos
Sao Paulo Medical Journal
BACKGROUND: Grading of Recommendations Assessment, Development and Evaluation (GRADE) is a tool f... more BACKGROUND: Grading of Recommendations Assessment, Development and Evaluation (GRADE) is a tool for assessing evidence produced in synthesis reports. OBJECTIVES: To present the translation into Portuguese of the GRADE checklist, whose original version is in English, and to describe and explain each topic, in order to provide examples to researchers and professionals who will use the tool.
Sao Paulo Medical Journal, Sep 12, 2022
BACKGROUND: Grading of Recommendations Assessment, Development and Evaluation (GRADE) is a tool f... more BACKGROUND: Grading of Recommendations Assessment, Development and Evaluation (GRADE) is a tool for assessing evidence produced in synthesis reports. OBJECTIVES: To present the translation into Portuguese of the GRADE checklist, whose original version is in English, and to describe and explain each topic, in order to provide examples to researchers and professionals who will use the tool.
SSRN Electronic Journal, 2020
SSRN Electronic Journal, 2021
O presente trabalho analisa, de maneira comparada, o tratamento legal, doutrinario e jurisprudenc... more O presente trabalho analisa, de maneira comparada, o tratamento legal, doutrinario e jurisprudencial dado ao contrato de franchising no Brasil e em Portugal. Destaca, sempre sob a otica comparada, suas principais caracteristicas, seus elementos essenciais, seus diferentes tipos e sua insercao no ordenamento juridico de cada pais. Ressalta identidades e distincoes e traz a baila a indenizacao de clientela do modelo Portugues, pouco ou nada aplicada na jurisprudencia ou doutrina brasileiras.
Os estados, em termos de globalizacao, sofreram intensas modificacoes. Ao mesmo tempo em que se t... more Os estados, em termos de globalizacao, sofreram intensas modificacoes. Ao mesmo tempo em que se tornam "minimos", voltados a normalizacao e regulacao do mercado, passam a encontrar fundamento de legitimidade na protecao e garantia dos direitos fundamentais. A constitucionalizacao do direito, ao lado do neoconstitucionalismo, fez emergir um antes inedito poder politico do judiciario nas relacoes entre os poderes. Como consequencia, o ativismo judicial e a judicializacao da politica passaram a integrar o quotidiano das tensoes estatais, carregando consigo os impactos e riscos de uma discricionariedade forte ou de um livre convencimento irrestrito nas decisoes judiciais, especialmente em uma quadra historica marcada pela complexidade tecnologica, social e economica...
SSRN Electronic Journal, 2021
PeerJ, 2015
The relationship between clinical research and the pharmaceutical industry has placed clinical tr... more The relationship between clinical research and the pharmaceutical industry has placed clinical trials in jeopardy. According to the medical literature, more than 70% of clinical trials are industry-funded. Many of these trials remain unpublished or have methodological flaws that distort their results. In 2007, it was signed into law the Food and Drug Administration Amendments Act (FDAAA), aiming to provide publicly access to a broad range of biomedical information to be made available on the platform ClinicalTrials (available at https://www.clinicaltrials.gov). We accessed ClinicalTrials.gov and evaluated the compliance of researchers and sponsors with the FDAAA. Our sample comprised 243 protocols of clinical trials of biological monoclonal antibodies (mAb) adalimumab, bevacizumab, infliximab, rituximab, and trastuzumab. We demonstrate that the new legislation has positively affected transparency patterns in clinical research, through a significant increase in publication and online...
Diagn Tratamento, Mar 1, 2010
The relationship between clinical research and the pharmaceutical industry has placed clinical tr... more The relationship between clinical research and the pharmaceutical industry has placed clinical trials in jeopardy. According to the medical literature, more than 70% of clinical trials are industry-funded. Many of these trials remain unpublished or have methodological flaws that distort their results. In 2007, it was signed into law the Food and Drug Administration Amendments Act (FDAAA), aiming to provide publicly access to a broad range of biomedical information to be made available on the platform ClinicalTrials (https://www.clinicaltrials.gov). We accessed ClinicalTrials.gov and evaluated the compliance of researchers and sponsors with the FDAAA. Our sample comprised 243 protocols of clinical trials of biological monoclonal antibodies (mAb) adalimumab, bevacizumab, infliximab, rituximab, and trastuzumab. We demonstrate that the new legislation has positively affected transparency patterns in clinical research, through a significant increase in publication and online reporting rates. Poorly designed trials, however, remain a challenge to be overcome, due to a high prevalence of methodological flaws. These flaws affect the quality of clinical information available, breaching ethical duties of sponsors and researchers, as well as the human right to health.
Sao Paulo Medical Journal
BACKGROUND: Grading of Recommendations Assessment, Development and Evaluation (GRADE) is a tool f... more BACKGROUND: Grading of Recommendations Assessment, Development and Evaluation (GRADE) is a tool for assessing evidence produced in synthesis reports. OBJECTIVES: To present the translation into Portuguese of the GRADE checklist, whose original version is in English, and to describe and explain each topic, in order to provide examples to researchers and professionals who will use the tool.
Sao Paulo Medical Journal, Sep 12, 2022
BACKGROUND: Grading of Recommendations Assessment, Development and Evaluation (GRADE) is a tool f... more BACKGROUND: Grading of Recommendations Assessment, Development and Evaluation (GRADE) is a tool for assessing evidence produced in synthesis reports. OBJECTIVES: To present the translation into Portuguese of the GRADE checklist, whose original version is in English, and to describe and explain each topic, in order to provide examples to researchers and professionals who will use the tool.
SSRN Electronic Journal, 2020
SSRN Electronic Journal, 2021
O presente trabalho analisa, de maneira comparada, o tratamento legal, doutrinario e jurisprudenc... more O presente trabalho analisa, de maneira comparada, o tratamento legal, doutrinario e jurisprudencial dado ao contrato de franchising no Brasil e em Portugal. Destaca, sempre sob a otica comparada, suas principais caracteristicas, seus elementos essenciais, seus diferentes tipos e sua insercao no ordenamento juridico de cada pais. Ressalta identidades e distincoes e traz a baila a indenizacao de clientela do modelo Portugues, pouco ou nada aplicada na jurisprudencia ou doutrina brasileiras.
Os estados, em termos de globalizacao, sofreram intensas modificacoes. Ao mesmo tempo em que se t... more Os estados, em termos de globalizacao, sofreram intensas modificacoes. Ao mesmo tempo em que se tornam "minimos", voltados a normalizacao e regulacao do mercado, passam a encontrar fundamento de legitimidade na protecao e garantia dos direitos fundamentais. A constitucionalizacao do direito, ao lado do neoconstitucionalismo, fez emergir um antes inedito poder politico do judiciario nas relacoes entre os poderes. Como consequencia, o ativismo judicial e a judicializacao da politica passaram a integrar o quotidiano das tensoes estatais, carregando consigo os impactos e riscos de uma discricionariedade forte ou de um livre convencimento irrestrito nas decisoes judiciais, especialmente em uma quadra historica marcada pela complexidade tecnologica, social e economica...
SSRN Electronic Journal, 2021
PeerJ, 2015
The relationship between clinical research and the pharmaceutical industry has placed clinical tr... more The relationship between clinical research and the pharmaceutical industry has placed clinical trials in jeopardy. According to the medical literature, more than 70% of clinical trials are industry-funded. Many of these trials remain unpublished or have methodological flaws that distort their results. In 2007, it was signed into law the Food and Drug Administration Amendments Act (FDAAA), aiming to provide publicly access to a broad range of biomedical information to be made available on the platform ClinicalTrials (available at https://www.clinicaltrials.gov). We accessed ClinicalTrials.gov and evaluated the compliance of researchers and sponsors with the FDAAA. Our sample comprised 243 protocols of clinical trials of biological monoclonal antibodies (mAb) adalimumab, bevacizumab, infliximab, rituximab, and trastuzumab. We demonstrate that the new legislation has positively affected transparency patterns in clinical research, through a significant increase in publication and online...
Diagn Tratamento, Mar 1, 2010
The relationship between clinical research and the pharmaceutical industry has placed clinical tr... more The relationship between clinical research and the pharmaceutical industry has placed clinical trials in jeopardy. According to the medical literature, more than 70% of clinical trials are industry-funded. Many of these trials remain unpublished or have methodological flaws that distort their results. In 2007, it was signed into law the Food and Drug Administration Amendments Act (FDAAA), aiming to provide publicly access to a broad range of biomedical information to be made available on the platform ClinicalTrials (https://www.clinicaltrials.gov). We accessed ClinicalTrials.gov and evaluated the compliance of researchers and sponsors with the FDAAA. Our sample comprised 243 protocols of clinical trials of biological monoclonal antibodies (mAb) adalimumab, bevacizumab, infliximab, rituximab, and trastuzumab. We demonstrate that the new legislation has positively affected transparency patterns in clinical research, through a significant increase in publication and online reporting rates. Poorly designed trials, however, remain a challenge to be overcome, due to a high prevalence of methodological flaws. These flaws affect the quality of clinical information available, breaching ethical duties of sponsors and researchers, as well as the human right to health.