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1.
Biom J ; 61(5): 1232-1241, 2019 09.
Artigo em Inglês | MEDLINE | ID: mdl-30589102

RESUMO

Data Monitoring Committees (DMCs) are an integral part of clinical drug development. Their use has evolved along with changing study designs and regulatory expectations, which has associated statistical and ethical implications. Although there is guidance from the different regulatory agencies, there are opportunities to bring more consistency to address practical issues of establishing and operating a DMC. Challenging issues include defining the scope of DMC decisions, the regulatory requirements and expectations, the perceived independence of DMCs, the specific focus primarily on safety, etc. Wider use of adaptive clinical trial designs in recent years introduce additional challenges in terms of trial governance and the complexity of DMC activities. A panel comprised of clinical and statistical experts from across academia, industry, and regulatory agencies shared their experience and thoughts on the importance of these aspects and offered perspectives on the future of the DMCs. This paper documents the thinking from the panel session at the CEN-ISBS conference held in Vienna, Austria, 2017.


Assuntos
Comitês de Monitoramento de Dados de Ensaios Clínicos/economia , Comitês de Monitoramento de Dados de Ensaios Clínicos/legislação & jurisprudência , Controle Social Formal , Comitês de Monitoramento de Dados de Ensaios Clínicos/organização & administração , Guias como Assunto , Humanos
2.
Eur J Clin Pharmacol ; 72(4): 399-412, 2016 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-26729259

RESUMO

PURPOSE: Monitoring is a costly requirement when conducting clinical trials. New regulatory guidance encourages the industry to consider alternative monitoring methods to the traditional 100 % source data verification (SDV) approach. The purpose of this literature review is to provide an overview of publications on different monitoring methods and their impact on subject safety data, data integrity, and monitoring cost. METHODS: The literature search was performed by keyword searches in MEDLINE and hand search of key journals. All publications were reviewed for details on how a monitoring approach impacted subject safety data, data integrity, or monitoring costs. RESULTS: Twenty-two publications were identified. Three publications showed that SDV has some value for detection of not initially reported adverse events and centralized statistical monitoring (CSM) captures atypical trends. Fourteen publications showed little objective evidence of improved data integrity with traditional monitoring such as 100 % SDV and sponsor queries as compared to reduced SDV, CSM, and remote monitoring. Eight publications proposed a potential for significant cost reductions of monitoring by reducing SDV without compromising the validity of the trial results. CONCLUSIONS: One hundred percent SDV is not a rational method of ensuring data integrity and subject safety based on the high cost, and this literature review indicates that reduced SDV is a viable monitoring method. Alternative methods of monitoring such as centralized monitoring utilizing statistical tests are promising alternatives but have limitations as stand-alone tools. Reduced SDV combined with a centralized, risk-based approach may be the ideal solution to reduce monitoring costs while improving essential data quality.


Assuntos
Comitês de Monitoramento de Dados de Ensaios Clínicos/economia , Comitês de Monitoramento de Dados de Ensaios Clínicos/normas , Ensaios Clínicos como Assunto/economia , Ensaios Clínicos como Assunto/normas , Bases de Dados Factuais/economia , Bases de Dados Factuais/normas , Humanos
3.
Trials ; 16: 597, 2015 Dec 30.
Artigo em Inglês | MEDLINE | ID: mdl-26715378

RESUMO

BACKGROUND: The independent oversight of clinical trials, which is recommended by the Medical Research Council (MRC) Guidelines for Good Clinical Practice, is typically provided by an independent advisory Data Monitoring Committee (DMC) and an independent executive committee, to whom the DMC makes recommendations. The detailed roles and function of this executive committee, known as the Trial Steering Committee (TSC), have not previously been studied or reviewed since those originally proposed by the MRC in 1998. METHODS: An expert panel (n = 7) was convened comprising statisticians, clinicians and trial methodologists with prior TSC experience. Twelve questions about the role and responsibilities of the TSC were discussed by the panel at two full-day meetings. Each meeting was transcribed in full and the discussions were summarised. RESULTS: The expert panel reached agreement on the role of the TSC, to which it was accountable, the membership, the definition of independence, and the experience and training needed. The management of ethical issues, difficult/complex situations and issues the TSC should not ask the DMC to make recommendations on were more difficult to discuss without specific examples, but support existed for further work to help share issues and to provide appropriate training for TSC members. Additional topics discussed, which had not been identified by previous work relating to the DMCs but were pertinent to the role of the TSC, included the following: review of data sharing requests, indemnity, lifespan of the TSC, general TSC administration, and the roles of both the Funder and the Sponsor. CONCLUSIONS: This paper presents recommendations that will contribute to the revision and update of the MRC TSC terms of reference. Uncertainty remains in some areas due to the absence of real-life examples; future guidance on these issues would benefit from a repository of case studies. Notably, the role of a patient and public involvement (PPI) contributor was not discussed, and further work is warranted to explore the role of a PPI contributor in independent trial oversight.


Assuntos
Comitês Consultivos/normas , Comitês de Monitoramento de Dados de Ensaios Clínicos/normas , Ensaios Clínicos como Assunto/normas , Membro de Comitê , Papel Profissional , Projetos de Pesquisa/normas , Pesquisadores/normas , Comitês Consultivos/economia , Comitês Consultivos/ética , Comitês de Monitoramento de Dados de Ensaios Clínicos/economia , Comitês de Monitoramento de Dados de Ensaios Clínicos/ética , Ensaios Clínicos como Assunto/economia , Ensaios Clínicos como Assunto/ética , Ensaios Clínicos como Assunto/estatística & dados numéricos , Conflito de Interesses , Consenso , Interpretação Estatística de Dados , Humanos , Projetos de Pesquisa/estatística & dados numéricos , Pesquisadores/economia , Pesquisadores/ética , Apoio à Pesquisa como Assunto/normas , Inquéritos e Questionários
4.
Am Heart J ; 168(2): 135-41.e1, 2014 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-25066551

RESUMO

Independent data monitoring committees (IDMCs) were introduced to monitor patient safety and study conduct in randomized clinical trials (RCTs), but certain challenges regarding the utilization of IDMCs have developed. First, the roles and responsibilities of IDMCs are expanding, perhaps due to increasing trial complexity and heterogeneity regarding medical, ethical, legal, regulatory, and financial issues. Second, no standard for IDMC operating procedures exists, and there is uncertainty about who should determine standards and whether standards should vary with trial size and design. Third, considerable variability in communication pathways exist across IDMC interfaces with regulatory agencies, academic coordinating centers, and sponsors. Finally, there has been a substantial increase in the number of RCTs using IDMCs, yet there is no set of qualifications to help guide the training and development of the next generation of IDMC members. Recently, an expert panel of representatives from government, industry, and academia assembled at the Duke Clinical Research Institute to address these challenges and to develop recommendations for the future utilization of IDMCs in RCTs.


Assuntos
Ensaios Clínicos Controlados Aleatórios como Assunto , Comitês de Monitoramento de Dados de Ensaios Clínicos/economia , Comitês de Monitoramento de Dados de Ensaios Clínicos/organização & administração , Comitês de Monitoramento de Dados de Ensaios Clínicos/normas , Comitês de Monitoramento de Dados de Ensaios Clínicos/estatística & dados numéricos , Comitês de Monitoramento de Dados de Ensaios Clínicos/tendências , Comunicação , Humanos
5.
Ger Med Sci ; 11: Doc04, 2013.
Artigo em Inglês | MEDLINE | ID: mdl-23382708

RESUMO

Since several years risk-based monitoring is the new "magic bullet" for improvement in clinical research. Lots of authors in clinical research ranging from industry and academia to authorities are keen on demonstrating better monitoring-efficiency by reducing monitoring visits, monitoring time on site, monitoring costs and so on, always arguing with the use of risk-based monitoring principles. Mostly forgotten is the fact, that the use of risk-based monitoring is only adequate if all mandatory prerequisites at site and for the monitor and the sponsor are fulfilled.Based on the relevant chapter in ICH GCP (International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use - Good Clinical Practice) this publication takes a holistic approach by identifying and describing the requirements for future monitoring and the use of risk-based monitoring. As the authors are operational managers as well as QA (Quality Assurance) experts, both aspects are represented to come up with efficient and qualitative ways of future monitoring according to ICH GCP.


Assuntos
Comitês de Monitoramento de Dados de Ensaios Clínicos/economia , Comitês de Monitoramento de Dados de Ensaios Clínicos/tendências , Ensaios Clínicos como Assunto/economia , Ensaios Clínicos como Assunto/tendências , Indústria Farmacêutica/economia , Indústria Farmacêutica/tendências , Monitoramento de Medicamentos/economia , Monitoramento de Medicamentos/tendências , Drogas em Investigação/efeitos adversos , Drogas em Investigação/uso terapêutico , Saúde Holística/economia , Saúde Holística/tendências , Garantia da Qualidade dos Cuidados de Saúde/economia , Garantia da Qualidade dos Cuidados de Saúde/tendências , Medição de Risco/economia , Medição de Risco/tendências , Gestão da Qualidade Total/tendências , Sistemas de Notificação de Reações Adversas a Medicamentos/economia , Sistemas de Notificação de Reações Adversas a Medicamentos/tendências , Comportamento Cooperativo , Redução de Custos/tendências , Documentação/economia , Documentação/tendências , Registros Eletrônicos de Saúde/economia , Registros Eletrônicos de Saúde/tendências , Alemanha , Humanos , Capacitação em Serviço/economia , Capacitação em Serviço/tendências , Comunicação Interdisciplinar , Segurança do Paciente/economia , Seleção de Pacientes , Encaminhamento e Consulta/economia , Encaminhamento e Consulta/tendências , Gestão da Qualidade Total/economia
8.
Am J Bioeth ; 11(3): 2-10, 2011 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-21400374

RESUMO

If definitive evidence concerning treatment effectiveness becomes available from an ongoing randomized clinical trial, then the trial could be stopped early, with the public release of results benefiting current and future patients. However, stopping an ongoing trial based on accruing outcome data requires methodological rigor to preserve validity of the trial conclusions. This has led to the use of formal interim monitoring procedures, which include inefficacy monitoring that will stop a trial early when the experimental treatment appears not to be working. For participants, inefficacy monitoring is especially important as it ensures that they are not being treated worse than if they had not enrolled on the trial. We discuss the importance of reporting with trial results the formal interim inefficacy monitoring guidelines that were utilized, and, if none were used, the reasons for their absence. A survey of two leading medical journals suggests that this is not current practice.


Assuntos
Comitês de Monitoramento de Dados de Ensaios Clínicos , Término Precoce de Ensaios Clínicos , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Ensaios Clínicos Controlados Aleatórios como Assunto/normas , Resultado do Tratamento , Comitês de Monitoramento de Dados de Ensaios Clínicos/economia , Medicina Baseada em Evidências , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto/economia , Reprodutibilidade dos Testes , Projetos de Pesquisa/normas , Segurança , Fatores de Tempo
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