Fornecimento de medicamento investigacional após o fim da pesquisa clínica – Revisão da literatura e das diretrizes nacionais e internacionais

Dainesi, Sonia Mansoldo; Goldbaum, Moisés

doi:10.1590/s0104-42302011000600021

Cited by 11 publications

(21 citation statements)

References 13 publications

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“…Patient organizations, such as the European Organization for Rare Diseases (Eurordis) in Europe and the National Organization for Rare Disorders (Nord) in the United States, play important roles in the field of rare diseases, mainly by encouraging the development of research and of guiding ethical principles, identifying DH, the Belmont Report, the International Ethical Guidelines for Biomedical Research Involving Humans Subjects, of the World Health Organization (WHO), the Universal Declaration on Bioethics and Human Rights (UDBDH) and the International Declaration on Human Genetic Data 7,16,36,42,43,46,49 as the main documents in guiding ethical research with humans. DH and DUBDH are highlighted as regulations that address access to post-trial drugs.…”

Section: Clinical Research With Orphan Drugsmentioning

confidence: 99%

Post-trial access to drugs for rare diseases: an integrative review

et al. 2022

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This study is an integrative literature review to analyze the scientific production about post-trial drug access by participants of clinical trials for rare diseases. The search was carried out in the Virtual Health Library, Embase, PubMed, SciELO, Scopus and Web of Science databases, covering 21 studies. Two categories emerged from the analysis: clinical research with orphan drugs and market regulation; and access to orphan drugs: background, globalization and the right to health. The first analyzes issues related to the number of patients with rare diseases, the efficacy and safety of these studies and the cost and price of medications. The second addresses the historical background of post-trial access, the globalization of clinical trials and the difficulties to ensure the right to post-trial access to orphan drugs. Few articles addressed post-trial drug access by participants with rare diseases as a central issue, which points to the importance of further studies on this subject.

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Section: Clinical Research With Orphan Drugsmentioning

confidence: 99%

Post-trial access to drugs for rare diseases: an integrative review

et al. 2022

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“…Regarding access to the drug researched after the conclusion of the clinical trial, there are controversies in the scientific community. Dainesi and Goldbaum 26 argue that the responsibility for supplying the drug investigated after the research should be analyzed on a case-by-case basis, since at the end of this research the drug tested is still experimental and must undergo safety and efficacy assessments. The Universal Declaration on Bioethics and Human Rights 21 , in its article 15, emphasizes that benefits from scientific research must be shared with society, highlighting the importance of this act of sharing with developing countries.…”

Section: Declaration Of Helsinkimentioning

confidence: 99%

“…This position was in line with that proposed by the National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária -ANVISA), which defended, in a meeting held in 2009, the provision of the trial product as an extension of the study. This guarantees the follow-up of the participant by the protocol and the delivery of the medication used in the original study, maintaining, through its perspective, control of the research and taking care of the safety of the individuals involved 26 .…”

Section: Resolução Cns 466/2012 [Cns Resolution 466/2012]mentioning

confidence: 99%

Pesquisa clínica sob a ótica da integridade

Feijó¹,

Crippa²,

Giordani³

et al. 2018

Rev. Bioét.

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Resumo Toda publicação advinda de pesquisa científica exige respeito aos padrões de ética que caracterizam a adequada conduta do investigador, o que se traduz em integridade na pesquisa. Porém, há distinta modalidade de pesquisa, conhecida como “pesquisa clínica”, que vem buscando atuar de maneira íntegra visando fortalecer a base de seu agir em prol da sociedade em geral. A caracterização dos envolvidos e sua função ideal e real no cenário moderno foi o objetivo deste trabalho. A busca e descoberta de novas drogas beneficiarão toda coletividade, se as políticas de saúde pública forem eficazes, normatizando o acesso da população a essas descobertas. A integridade na pesquisa, portanto, precisa ampliar seus horizontes para abarcar também a pesquisa clínica, cujos partícipes devem ser orientados e cobrados quanto à boa prática nas diversas etapas de desenvolvimento do estudo, o que permitirá íntegra e exitosa investigação.

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“…However, the bioethical debate in the world on who should shoulder the continuity of post-clinical trials for patients with medical indication remains obscure and introduces uncertainties to the patients involved in the trials. In this sense, continuity of treatment after the end of the clinical trial has been ethically debated around the world since 1980 among researchers, health professionals, drug regulatory agencies, ethics committees, and research volunteers [5]. A study focus on staff experiences of closing out a clinical trial involving withdrawal of treatment revealed that the ending of a clinical trial may be challenging.…”

Section: Introductionmentioning

confidence: 99%

“…The post-clinical treatment continuity was only incorporated in the 2000s by the Declaration of Helsinki [5]. In 2003, the International AIDS Society (IAS) defined continuity of treatment as: the ethical responsibility to compensate volunteer individuals who agreed to participate in the research and who were exposed to risks, invasive procedures, among others [8].…”

Section: Introductionmentioning

confidence: 99%

Who should pay for the continuity of post-trial health care treatments?

Iunes

Uribe

Torres

et al. 2019

Int J Equity Health

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Background The bioethical debate in the world on who should pay for the continuity of post-trials treatment of patients that have medical indication remains obscure and introduces uncertainties to the patients involved in the trials. The continuity of post-trial treatment was only incorporated in the 2000s by the Helsinki Declaration. The Universal Declaration on Bioethics and Human Rights, published in 2006, points out that post-trial continuity may present a broader scope than just the availability of the investigated medicine. In the latest version of this Declaration, in 2013, it was stated that “prior to the start of the clinical trial, funders, researchers and governments of the countries participating in the research should provide post-trial access for all participants who still require an intervention that was identified as beneficial. This information should also be disclosed to participants during the informed consent process”. However, a systematic review on the registration of phase III and IV clinical trials, from the clinical trials website, demonstrated that the understanding of the various guidelines and resolutions is conflicting, generating edges in the post-trial setting. For the health authorities of countries where clinical trials take place, the uncertainties about the continuity of the treatments generate gaps in care and legal proceedings against health systems, which are forced to pay for the treatments, even if they are not included in the list of medicines available to the population. Methods Fifty-one representatives from the health, judicial, legislative, patient and academic organizations of eight countries of Latin American and South Korea took part in a meeting in Chile, in 2017, to discuss the responsibility of the treatment continuation after clinical trials. From a hypothetical case of development of a new drug and its studies of efficacy and safety, the participants, divided in groups, proposed recommendations for the problem and pointed out the pros and cons of adopting each recommendation. The groups were, afterwards, confronted by a simulated jury and, finally, issued a final recommendation for the problem. Then, an analysis was made on the content of the recommendations and the pros and cons in adopting conservative or liberal positions, besides the possible impacts of a restrictive regulation regarding the conduction of clinical trials, pointed out by the groups, before and after the simulated jury. Results The theme was widely discussed and about 12 recommendations were proposed by the participants. The main ones took into account aspects related to patients’ rights, economic factors and the development of new technologies, above the position of industry and research institutes, as well as the legislation in force in each country. Conclusion The countries of Latin America and South Korea, currently, do not have laws that address patients’ rights, moreover, there is no...

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Fornecimento de medicamento investigacional após o fim da pesquisa clínica – Revisão da literatura e das diretrizes nacionais e internacionais

Cited by 11 publications

References 13 publications

Post-trial access to drugs for rare diseases: an integrative review

Post-trial access to drugs for rare diseases: an integrative review

Pesquisa clínica sob a ótica da integridade

Who should pay for the continuity of post-trial health care treatments?

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