Use este identificador para citar ou linkar para este item: http://bibliotecadigital.anvisa.gov.br/jspui/handle/anvisa/1686
Título: The patient's safety and access to experimental drugs after the termination of clinical trials : regulations and trends
Autor(es): Silva, Ricardo Eccard da
Amato, Angélica Amorim
Sousa, Thiago do Rego
Carvalho, Marta Rodrigues de
Novaes, Maria Rita Carvalho Garbi
Ano de publicação: 2018
Resumo: Purpose Participants’ rights and safety must be guaranteed not only while a clinical trial is being conducted but also when a clinical trial finishes. The criteria for post-trial access to experimental drugs, however, are unclear in various countries. The objectives of this study were (i) to ascertain if there were regulations or guidelines related to patients’ access to drugs after the end of clinical trials in the countries selected in the study and (ii) to analyze trends in post-trial access in countries classified by their level of economic development. Methods This study is a retrospective review. The data are from the records of clinical trials from 2014 registered in the World Health Organization’s International Clinical Trials Registry Platform (ICTRP) database. Results Among the countries selected, provision of drugs post-trial is mandatory only in Argentina, Brazil, Chile, Finland, and Peru. The plans for post-trial access tend to be more present in low- and middle-income and upper middle-income countries, in comparison with high-income countries. Studies involving vulnerable populations are 2.53 times more likely to have plans for post-trial access than studies which do not. Conclusions The guaranteeing of post-trial access remains mandatory in few countries. Considering that individuals seen as vulnerable have been included in clinical trials without plans for post-trial access, stakeholders must discuss the need to develop regulations mandating the guaranteeing of post-trial access in specified situations.
Informações Adicionais: Received: 9 January 2018 -- Accepted: 2 May 2018 -- Published online: 12 May 2018
Como citar: SILVA, Ricardo Eccard da; AMATO, Angélica Amorim; SOUSA, Thiago do Rego; CARVALHO, Marta Rodrigues de; NOVAES, Maria Rita Carvalho Garbi. The patient's safety and access to experimental drugs after the termination of clinical trials: regulations and trends. European Journal of Clinical Pharmacology, [Germany], v. 74, n. 8, May 2018. DOI 10.1007/s00228-018-2474-9. Disponível em: https://link.springer.com/article/10.1007/s00228-018-2474-9. Acesso em: 6 set. 2022
Palavra Chave: Clinical trials

Drugs

Access

Ethics

Continuity of patient care

ENSAIOS CLÍNICOS

Drogas

Acesso

Ética

Continuidade do atendimento ao paciente
Tipo: Artigo
Aparece nas coleções:Gestão de Dados e Informação



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