Your browser doesn't support javascript.
Mostrar: 20 | 50 | 100
Resultados 1 - 20 de 1.067
Filtrar
1.
Lancet ; 395(10226): 828-838, 2020 03 07.
Artigo em Inglês | MEDLINE | ID: mdl-32145797

RESUMO

Placebo comparisons are increasingly being considered for randomised trials assessing the efficacy of surgical interventions. The aim of this Review is to provide a summary of knowledge on placebo controls in surgical trials. A placebo control is a complex type of comparison group in the surgical setting and, although powerful, presents many challenges. This Review outlines what a placebo control entails and present understanding of this tool in the context of surgery. We consider when placebo controls in surgery are acceptable (and when they are desirable) in terms of ethical arguments and regulatory requirements, how a placebo control should be designed, how to identify and mitigate risk for participants in these trials, and how such trials should be done and interpreted. Use of placebo controls is justified in randomised controlled trials of surgical interventions provided there is a strong scientific and ethical rationale. Surgical placebos might be most appropriate when there is poor evidence for the efficacy of the procedure and a justified concern that results of a trial would be associated with high risk of bias, particularly because of the placebo effect. Feasibility work is recommended to optimise the design and implementation of randomised controlled trials. This Review forms an outline for best practice and provides guidance, in the form of the Applying Surgical Placebo in Randomised Evaluations (known as ASPIRE) checklist, for those considering the use of a placebo control in a surgical randomised controlled trial.


Assuntos
Placebos , Ensaios Clínicos Controlados Aleatórios como Assunto , Procedimentos Cirúrgicos Operatórios , Guias como Assunto , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto/ética , Ensaios Clínicos Controlados Aleatórios como Assunto/normas , Projetos de Pesquisa
2.
BMC Public Health ; 19(1): 997, 2019 Jul 24.
Artigo em Inglês | MEDLINE | ID: mdl-31340795

RESUMO

BACKGROUND: The term evidence based medicine was introduced in the early 1990s in clinical medicine to educate clinicians about how to assess the 'credibility' of research to ensure best treatments for their patients. The evidence based medicine paradigm has become more diffuse in times of austerity and randomised controlled designs are being used to address complex issues in public health and disability research. This research is not addressing inequalities in terms of disability nor how people can live well with disabilities. MAIN TEXT: We argue that there are four ways that public health research needs to change if it wants to address inequalities linked to disability: 1) rethinking theoretical connections between public health and disability; 2) building ethics and equity into interventions through a human rights approach; 3) ensuring ethical inclusion through intersectionality; and 4) evaluating policy and other social impacts to ensure they capture diversity. We argue that these are key issues to building a social determinants of flourishing. CONCLUSIONS: We need to understand how disability might have an accumulative impact across the life course, as well as how to ensure equity for people living with disabilities. This means conceptualising a social determinants of flourishing where we evaluate how exactly randomised controlled trials and public health interventions, not only lead to greater equality but also ensure rights to health and wellbeing.


Assuntos
Pessoas com Deficiência , Direitos Humanos , Saúde Pública/ética , Ensaios Clínicos Controlados Aleatórios como Assunto/ética , Determinantes Sociais da Saúde/ética , Ética em Pesquisa , Política de Saúde , Humanos , Fatores Socioeconômicos
4.
BMC Med Ethics ; 20(1): 54, 2019 07 27.
Artigo em Inglês | MEDLINE | ID: mdl-31351474

RESUMO

BACKGROUND: The development of the CRISPR/Cas9 gene editing system has generated new possibilities for the use of gene drive constructs to reduce or suppress mosquito populations to levels that do not support disease transmission. Despite this prospect, social resistance to genetically modified organisms remains high. Gene drive open field research thus raises important questions regarding what is owed to those who may not consent to such research, or those could be affected by the proposed research, but whose consent is not solicited. The precise circumstances under which informed consent must be obtained, and from whom, requires careful consideration. Furthermore, appropriate engagement processes should be central to any introduction of genetically modified mosquitos in proposed target settings. DISCUSSION: In this work, international guidance documents on informed consent and engagement are reviewed and applied to the genetically modified mosquito research context. Five analogous research endeavours that involve area-wide / open field experiments are reviewed. The approach of each in respect to the solicitation of individual informed consent and community engagement are highlighted. CONCLUSIONS: While the solicitation of individual informed consent in host settings of gene drive field trials may not be possible or feasible in some instances, local community and stakeholder engagement will be key to building trust towards the proposed conduct of such research. In this regard, the approaches taken by investigators and sponsors of political science field research and weather modification field research should be avoided. Rather, proponents of gene drive field research should look to the Eliminate Dengue field trials, cluster randomised trials, and pragmatic clinical trials for guidance regarding how the solicitation of individual informed consent of host communities ought to be managed, and how these communities ought to be engaged.


Assuntos
Controle de Doenças Transmissíveis , Participação da Comunidade , Pesquisa Participativa Baseada na Comunidade/ética , Tecnologia de Impulso Genético/ética , Consentimento Livre e Esclarecido , Animais , Controle de Doenças Transmissíveis/métodos , Pesquisa Participativa Baseada na Comunidade/métodos , Pesquisa Participativa Baseada na Comunidade/normas , Culicidae/genética , Dengue/prevenção & controle , Transmissão de Doença Infecciosa/prevenção & controle , Tecnologia de Impulso Genético/métodos , Humanos , Consentimento Livre e Esclarecido/ética , Consentimento Livre e Esclarecido/normas , Controle de Mosquitos/ética , Controle de Mosquitos/métodos , Mosquitos Vetores/genética , Ensaios Clínicos Controlados Aleatórios como Assunto/ética , Confiança , Wolbachia
8.
BMC Med Ethics ; 20(1): 27, 2019 04 27.
Artigo em Inglês | MEDLINE | ID: mdl-31029121

RESUMO

BACKGROUND: There is unanimous agreement regarding the need to ethically conduct research for improving therapy for patients admitted to hospital with acute conditions, including in emergency obstetric care. We present a conceptual analysis of ethical tensions inherent in the informed consent process for randomized clinical trials for emergency obstetric care and suggest ways in which these could be mitigated. DISCUSSION: A valid consenting process, leading to an informed consent, is a cornerstone of this aspect necessary for preservation and maintenance of respect for autonomy and dignity. In emergency obstetric care research, obtaining informed consent can be problematic, leading to ethical tension between different moral considerations. Potential participants may be vulnerable due to severity of disease, powerlessness or impaired decisional capacity. Time for the consent process is limited, and some interventions have a narrow therapeutic window. These factors create ethical tension in allowing potentially beneficial research while avoiding potential harms and maintaining respect for dignity, human rights, justice and autonomy of the participants. CONCLUSION: Informed consent in emergency obstetric care in low- and middle-income countries poses numerous ethical challenges. Allowing research on vulnerable populations while maintaining respect for participant dignity and autonomy, protecting participants from potential harms and promoting justice underlie the ethical tensions in the research in emergency obstetric and newborn care. Those involved in research conduct or oversight have a duty of fair inclusion, to avoid denying participants the right to participate and to any potential research benefits.


Assuntos
Parto Obstétrico/ética , Países em Desenvolvimento , Serviços Médicos de Emergência/ética , Consentimento Informado por Menores/ética , Consentimento Livre e Esclarecido/ética , Terapia Intensiva Neonatal/ética , Ensaios Clínicos Controlados Aleatórios como Assunto/ética , Humanos , Recém-Nascido
10.
Rev. bras. cir. plást ; 34(1): 86-93, jan.-mar. 2019. tab
Artigo em Inglês, Português | LILACS | ID: biblio-994552

RESUMO

Introdução: Em dois estudos prévios, avaliou-se a qualidade dos ensaios clínicos aleatórios (ECAs) com a participação de pelo menos um cirurgião plástico, em dois períodos: 1966 a 2003 e 2004 a 2008. O objetivo é avaliar a evolução da qualidade das publicações de ECAs por cirurgiões plásticos no período subsequente de cinco anos, de 2009 a 2013. Métodos: ECAs publicados de 2009 a 2013, em língua inglesa, com a participação de pelo menos um cirurgião plástico, foram identificados por busca eletrônica e classificados quanto ao sigilo de alocação, por dois avaliadores independentes. Os estudos com sigilo de alocação adequado tiveram a qualidade avaliada por dois avaliadores, utilizando-se a Lista de Delphi e a Escala de Qualidade de Jadad. Resultados: Dos 6.997 estudos identificados, 261 foram classificados quanto ao sigilo de alocação. Destes, 43 (16,47%) tinham sigilo de alocação adequado. Segundo a avaliação pela Lista de Delphi, houve melhora, em relação a 1966-2003, nos itens "características mais importantes do prognóstico" (p < 0,001), "uso de avaliador independente" (p = 0,0029) e "medidas de variabilidade e estimativa de pontos para a variável primária" (p = 0,0057); não houve diferença em relação a 2004-2008. Quanto à Escala de Qualidade de Jadad, houve um aumento dos escores em relação a 1996-2003 (p < 0,0004), mas também sem diferença significante em relação ao período 2004-2008. Conclusão: Não houve diferença na qualidade das publicações de ECAs por cirurgiões plásticos no período de 2009 a 2013, em relação aos cinco anos anteriores (2004 a 2008). Entretanto, ambos os períodos apresentaram maior qualidade quando comparados ao período de 1966 a 2003.


Introduction: In two previous studies, the quality of randomized clinical trials (RCTs) with the participation of at least one plastic surgeon was assessed in two periods: from 1966 to 2003 and from 2004 to 2008. The objective is to evaluate the evolution of the quality of RCTs published by plastic surgeons in the subsequent five-year period, from 2009 to 2013. Methods: RCTs published from 2009 to 2013, in English, with the participation of at least one plastic surgeon, were identified by an electronic search and classified according to allocation concealment by two independent evaluators. The quality of the studies with adequate allocation concealment was evaluated by two evaluators using the Delphi List and the Jadad Scale. Results: Of the 6,997 identified studies, 261 were classified according to allocation concealment. Of these, 43 (16.47%) had adequate allocation concealment. According to an assessment conducted using the Delphi List, there was an improvement in the items "most important characteristics of the prognosis" (p < 0.001), "use of an independent evaluator" (p = 0.0029), and "measures of variability and estimation of points for the primary variable" (p = 0.0057) compared to the 1966-2003 assessment ; there was no difference in the assessment of the same items from 2004-2008. Regarding the Jadad Scale, there was an increase in the scores from 2009 to 2013 compared to the 1996-2003 period (p < 0.0004); however, there was no significant difference in the 2004-2008 period. Conclusion: There was no difference in the quality of the RCTs published by plastic surgeons in the 2009-2013 period compared to the previous five-year period (2004 to 2008). However, both periods indicated higher quality compared to the 1966-2003 period.


Assuntos
Humanos , Masculino , Feminino , Adulto , Pessoa de Meia-Idade , Cirurgia Plástica/efeitos adversos , Cirurgia Plástica/métodos , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Ensaios Clínicos Controlados Aleatórios como Assunto/estatística & dados numéricos , Ensaios Clínicos Controlados Aleatórios como Assunto/ética , Análise Estatística , Mecanismos de Avaliação da Assistência à Saúde/estatística & dados numéricos
13.
Cancer Treat Rev ; 74: 15-20, 2019 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-30665053

RESUMO

Progress in and better understanding of cancer biology causes a shift in cancer drug development: away from the evaluation of drugs in large tumour histology defined patient populations towards targeted agents in increasingly heterogeneous molecularly defined subpopulations. This requires novel approaches in clinical trial design by academia and industry, and development of new assessment tools by regulatory authorities. Pharmaceutical industry is developing new targeted agents generating many clinical studies, including target combinations. This requires improved operational efficiency by development of innovative trial designs, strategies for early-stage decision making and early selection of candidate drugs with a high likelihood of success. In addition, patient awareness and ethical considerations necessitate that agents will be rapidly available to patients. Regulatory Authorities such as the European Medicine Agency and national agencies recognise that these changes require a different attitude towards benefit-risk analysis for drug approval. The gold standard of randomised confirmatory Phase III trials is not always ethical or feasible when developing drugs for treatment of small cancer populations. Alternative strategies comprise accelerated approval via conditional marketing approval, which can be granted in the EU based on small non-randomised Phase II trials. The paper describes innovative trial designs with their pros and cons and efforts of pharmaceutical industry and regulatory authorities to deal with the paradigm shift. Furthermore, all stakeholders should continue to share their experiences and discuss problems in order to understand the position and concerns of the other stakeholders to learn from each other and to progress the field of novel oncology clinical trial design.


Assuntos
Ensaios Clínicos como Assunto/métodos , Antineoplásicos , Ensaios Clínicos como Assunto/ética , Ensaios Clínicos como Assunto/normas , Ensaios Clínicos Fase I como Assunto/ética , Ensaios Clínicos Fase I como Assunto/métodos , Ensaios Clínicos Fase I como Assunto/normas , Ensaios Clínicos Fase II como Assunto/ética , Ensaios Clínicos Fase II como Assunto/métodos , Ensaios Clínicos Fase II como Assunto/normas , Ensaios Clínicos Fase III como Assunto/ética , Ensaios Clínicos Fase III como Assunto/métodos , Ensaios Clínicos Fase III como Assunto/normas , Desenvolvimento de Medicamentos , Humanos , Oncologia/ética , Oncologia/métodos , Oncologia/normas , Terapia de Alvo Molecular , Ensaios Clínicos Controlados Aleatórios como Assunto/ética , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Ensaios Clínicos Controlados Aleatórios como Assunto/normas
14.
Bioethics ; 33(1): 35-42, 2019 01.
Artigo em Inglês | MEDLINE | ID: mdl-30198594

RESUMO

In 2004, the first ever multi-sited clinical trials studied the prospect of HIV biomedical prevention (referred to as pre-exposure prophylaxis-'PrEP'). The trials were implemented at several international sites, but many officially closed down before they completed. At most sites, both scientists and community AIDS advocates raised concerns over the ethics and scientific rationales of the trial. Focusing on the Nigerian trial site, we detail the controversy that emerged among mostly Nigerian research scientists who scrutinized the research design and protocol. While some of the disputes, especially those pertaining to community engagement mechanisms, were ultimately resolved in international fora and implemented in later PrEP trials, concerns over science rationales and assumptions were never addressed. We argue that scientific rationales should be treated as ethical concerns and suggest that such concerns should be deliberated at host sites before the trial protocol is finalized.


Assuntos
Fármacos Anti-HIV/uso terapêutico , Pesquisa Biomédica/ética , Análise Ética , Infecções por HIV/prevenção & controle , Profilaxia Pré-Exposição , Pesquisadores/ética , Tenofovir/uso terapêutico , Síndrome de Imunodeficiência Adquirida/prevenção & controle , Participação da Comunidade , Dissidências e Disputas , Ética em Pesquisa , HIV , Humanos , Nigéria , Defesa do Paciente , Ensaios Clínicos Controlados Aleatórios como Assunto/ética , Projetos de Pesquisa , Pensamento/ética
16.
J Clin Epidemiol ; 106: 80-87, 2019 02.
Artigo em Inglês | MEDLINE | ID: mdl-30366063

RESUMO

OBJECTIVES: Court documents have proven that a manufacturer-orchestrated strategy tried to promote gabapentin by distorting evidence in randomized trials. Given this background, we aimed to assess whether implausibly large treatment effects for gabapentin and for a similar gabapentinoid, pregabalin may have been published. STUDY DESIGN AND SETTING: We identified meta-analyses on gabapentin or pregabalin on any outcome from Google Scholar, PubMed, and EMBASE. We explored excess of significance in meta-analyses and whether outlier studies with extreme results (differing >0.8 standard deviations from the summary effect of the meta-analysis) were scrutinized. RESULTS: All 10 evaluated meta-analyses showed statistically significant favorable findings. Heterogeneity I2 estimates exceeding 90% were noted in four meta-analyses of postoperative pain. In these four meta-analyses, 77 studies had estimates differing >0.8 standard deviations from the summary estimate. Thirty-nine of 77 represented extremely favorable results, and 33 of them came from less developed countries with no tradition of clinical research, 22 reported no information on funding, and 20 reported no conflicts of interest. Conversely, 27 of 38 studies with unfavorable results came from more developed countries. CONCLUSION: Extremely favorable outlier studies in the meta-analyzed literature of gabapentin and pregabalin may be a footprint of bias in studies done in less developed countries.


Assuntos
Viés , Conflito de Interesses , Gabapentina/uso terapêutico , Metanálise como Assunto , Pregabalina/uso terapêutico , Ensaios Clínicos Controlados Aleatórios como Assunto/estatística & dados numéricos , Ensaios Clínicos Controlados Aleatórios como Assunto/normas , Países em Desenvolvimento/estatística & dados numéricos , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto/ética
17.
Bioethics ; 33(1): 4-12, 2019 01.
Artigo em Inglês | MEDLINE | ID: mdl-30474129

RESUMO

This paper evaluates four recent randomized clinical trials in which the informed consent of participants was either not sought at all, or else was conducted with critical information missing from the consent documents. As these studies have been taking place, various proposals to conduct randomized clinical trials without consent have been appearing in the medical literature. Some of the explanations offered for why it is appropriate to bypass consent or disclosure requirements appear to represent a fundamental misunderstanding of applicable government regulations and even the research enterprise. Others are the result of conceptual disagreements about the importance and application of traditional research ethics norms to 'comparative effectiveness research' and modern research environments. Common among these explanations, however, is a failure to appreciate when a research intervention, rather than merely an observation or review of data, is taking place. Review committees and investigators are failing to see, or choosing to ignore, interventions in the lives of research subjects. When these studies have come to light, government agencies with oversight authority have done little or backed down. Prestigious medical journals have published research results knowing that the required consent was not obtained, or they have stood by the published studies even after the inadequacy of consent is discovered. This article critically examines this erosion of consent in theory and practice and calls for restoring the requirement of informed consent to its proper place as a priority in human subjects research.


Assuntos
Pesquisa Biomédica/ética , Teoria Ética , Consentimento Livre e Esclarecido/ética , Projetos de Pesquisa , Valores Sociais , Pesquisa Biomédica/legislação & jurisprudência , Compreensão , Termos de Consentimento , Revelação , Comitês de Ética em Pesquisa , Ética em Pesquisa , Regulamentação Governamental , Humanos , Estudos Observacionais como Assunto , Editoração/ética , Ensaios Clínicos Controlados Aleatórios como Assunto/ética , Pesquisadores , Sujeitos da Pesquisa , Estados Unidos
18.
Rheumatology (Oxford) ; 58(5): 776-785, 2019 05 01.
Artigo em Inglês | MEDLINE | ID: mdl-30535001

RESUMO

OBJECTIVE: To examine the prevalence, types and temporal trends of reported financial conflicts of interest (FCOIs) among authors of drug therapy randomized controlled trials (RCTs) for RA and their association with study outcomes. METHODS: We identified original, non-phase 1, parallel-group, drug therapy RA RCTs published in the years 2002-03, 2006-07, and 2010-11. Two investigators independently obtained trial characteristics data. Authors' FCOIs were classified as honoraria/consultation fees receipt, employee status, research grant, and stock ownership. Multivariable logistic regression was performed to identify whether FCOIs were independently associated with study outcome. RESULTS: A total of 146 eligible RCTs were identified. Of these, 83 (58.4%) RCTs had at least one author with an FCOI [employee status: 63 (43.2%), honoraria/consultation fees receipt: 49 (33.6%), research grant: 30 (20.5%), and stock ownership: 28 (19.2%)]. A remarkable temporal increase in reporting of honoraria/consultation fees receipt, research grant, and stock ownership was seen. The reporting of any FCOI itself was not associated with positive outcome [50/73 (68.5%) with author FCOI vs 36/52 (69.2%) without author FCOI, P = 0.93]. However, honoraria/consulting fees receipt was independently associated with increased likelihood of a positive outcome [adjusted odds ratio (95% CI) of 3.24 (1.06-9.88)]. In general, trials with FCOIs were significantly more likely to be multicentre, have larger enrolment, use biologic or a small molecule as the experimental intervention, and have better reporting of some methodological quality measures. CONCLUSION: FCOI reporting in RA drug RCT authors is common and temporally increasing. Receipt of honoraria/consulting fees was independently associated with a positive study outcome.


Assuntos
Artrite Reumatoide/tratamento farmacológico , Conflito de Interesses , Ensaios Clínicos Controlados Aleatórios como Assunto/estatística & dados numéricos , Apoio à Pesquisa como Assunto/estatística & dados numéricos , Humanos , Modelos Logísticos , Razão de Chances , Ensaios Clínicos Controlados Aleatórios como Assunto/ética , Apoio à Pesquisa como Assunto/ética
19.
BMC Med Ethics ; 19(1): 96, 2018 12 20.
Artigo em Inglês | MEDLINE | ID: mdl-30572875

RESUMO

BACKGROUND: Genuine uncertainty on superiority of one intervention over the other is called equipoise. Physician-investigators in randomized controlled trials (RCT) need equipoise at least in studies with more than minimal risks. Ideally, this equipoise is also present in patient-participants. In pediatrics, data on equipoise are lacking. We hypothesize that 1) lack of equipoise at enrolment among parents may reduce recruitment; 2) lack of equipoise during participation may reduce retention in patients assigned to a less favoured treatment-strategy. METHODS: We compared preferences of parents/patients at enrolment, documented by a questionnaire (phase 1), with preferences developed during follow-up by an interview-study (phase 2) to investigate equipoise of child-participants and parents in the BeSt-for-Kids-study (NTR 1574). This trial in new-onset Juvenile Idiopathic Arthritis-patients consists of three strategies. One strategy comprises initial treatment with a biological disease-modifying-antirheumatic-drug (DMARD), currently not standard-of-care. Semi-structured interviews were conducted with 23 parents and 7 patients, median 11 months after enrolment. RESULTS: Initially most parents and children were not in equipoise. Parents/patients who refused participation, regularly declined due to specific preferences. Many participating families preferred the biological-first-strategy. They participated to have a chance for this initial treatment, and would even consider stopping trial-participation when not randomized for it. Their conviction of superiority of the biological-first strategy was based on knowledge from internet and close relations. According to four parents, the physician-investigator preferred the biological-first-strategy, but the majority (n = 19) stated that she had no preferred strategy. In phase 2, preferences tended to change to the treatment actually received. CONCLUSIONS: Lack of equipoise during enrolment did not reduce study recruitment, mainly due to the fact that preferred treatment was only available within the study. Still, when developing a trial it is important to evaluate whether the physicians' research question is in line with preferences of the patient-group. By exploring so-called 'informed patient-group'-equipoise, successful recruitment may be enhanced and bias avoided. In our study, lack of equipoise during trial-participation did not reduce retention in those assigned to a less favoured option. We observed a change for preference towards treatment actually received, possibly explained by comparable outcomes in all three arms.


Assuntos
Artrite Juvenil/tratamento farmacológico , Pais/psicologia , Preferência do Paciente/psicologia , Ensaios Clínicos Controlados Aleatórios como Assunto/ética , Equipolência Terapêutica , Adolescente , Adulto , Artrite Juvenil/terapia , Criança , Feminino , Humanos , Entrevistas como Assunto , Masculino , Pessoa de Meia-Idade , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Ensaios Clínicos Controlados Aleatórios como Assunto/psicologia , Método Simples-Cego , Inquéritos e Questionários
20.
BMC Med Ethics ; 19(1): 90, 2018 11 20.
Artigo em Inglês | MEDLINE | ID: mdl-30458809

RESUMO

BACKGROUND: Randomized controlled trial (RCT) trial designs exist on an explanatory-pragmatic spectrum, depending on the degree to which a study aims to address a question of efficacy or effectiveness. As conceptualized by Schwartz and Lellouch in 1967, an explanatory approach to trial design emphasizes hypothesis testing about the mechanisms of action of treatments under ideal conditions (efficacy), whereas a pragmatic approach emphasizes testing effectiveness of two or more available treatments in real-world conditions. Interest in, and the number of, pragmatic trials has grown substantially in recent years, with increased recognition by funders and stakeholders worldwide of the need for credible evidence to inform clinical decision-making. This increase has been accompanied by the onset of learning healthcare systems, as well as an increasing focus on patient-oriented research. However, pragmatic trials have ethical challenges that have not yet been identified or adequately characterized. The present study aims to explore the views of key stakeholders with respect to ethical issues raised by the design and conduct of pragmatic trials. It is embedded within a large, four-year project that seeks to develop guidance for the ethical design and conduct of pragmatic trials. As a first step, this study will address important gaps in the current empirical literature with respect to identifying a comprehensive range of ethical issues arising from the design and conduct of pragmatic trials. By opening up a broad range of topics for consideration within our parallel ethical analysis, we will extend the current debate, which has largely emphasized issues of consent, to the range of ethical considerations that may flow from specific design choices. METHODS: Semi-structured interviews with key stakeholders (e.g. trialists, methodologists, lay members of study teams, bioethicists, and research ethics committee members), across multiple jurisdictions, identified based on their known experience and/or expertise with pragmatic trials. DISCUSSION: We expect that the study outputs will be of interest to a wide range of knowledge users including trialists, ethicists, research ethics committees, journal editors, regulators, healthcare policymakers, research funders and patient groups. All publications will adhere to the Tri-Agency Open Access Policy on Publications.


Assuntos
Atitude do Pessoal de Saúde , Ensaios Clínicos Pragmáticos como Assunto/ética , Protocolos Clínicos , Humanos , Entrevistas como Assunto , Ensaios Clínicos Pragmáticos como Assunto/métodos , Ensaios Clínicos Controlados Aleatórios como Assunto/ética , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Projetos de Pesquisa , Pesquisadores/psicologia
SELEÇÃO DE REFERÊNCIAS
DETALHE DA PESQUISA