Your browser doesn't support javascript.
loading
Mostrar: 20 | 50 | 100
Resultados 1 - 20 de 2.112
Filtrar
2.
Contemp Clin Trials ; 104: 106368, 2021 05.
Artigo em Inglês | MEDLINE | ID: mdl-33775899

RESUMO

OBJECTIVES: COVID-19 pandemic caused several alarming challenges for clinical trials. On-site source data verification (SDV) in the multicenter clinical trial became difficult due to travel ban and social distancing. For multicenter clinical trials, centralized data monitoring is an efficient and cost-effective method of data monitoring. Centralized data monitoring reduces the risk of COVID-19 infections and provides additional capabilities compared to on-site monitoring. The key steps for on-site monitoring include identifying key risk factors and thresholds for the risk factors, developing a monitoring plan, following up the risk factors, and providing a management plan to mitigate the risk. METHODS: For analysis purposes, we simulated data similar to our clinical trial data. We classified the data monitoring process into two groups, such as the Supervised analysis process, to follow each patient remotely by creating a dashboard and an Unsupervised analysis process to identify data discrepancy, data error, or data fraud. We conducted several risk-based statistical analysis techniques to avoid on-site source data verification to reduce time and cost, followed up with each patient remotely to maintain social distancing, and created a centralized data monitoring dashboard to ensure patient safety and maintain the data quality. CONCLUSION: Data monitoring in clinical trials is a mandatory process. A risk-based centralized data review process is cost-effective and helpful to ignore on-site data monitoring at the time of the pandemic. We summarized how different statistical methods could be implemented and explained in SAS to identify various data error or fabrication issues in multicenter clinical trials.


Assuntos
COVID-19 , Ensaios Clínicos como Assunto , Confiabilidade dos Dados , Estudos Multicêntricos como Assunto , Projetos de Pesquisa/tendências , Gestão de Riscos , COVID-19/epidemiologia , COVID-19/prevenção & controle , Gestão de Mudança , Comitês de Monitoramento de Dados de Ensaios Clínicos/organização & administração , Ensaios Clínicos como Assunto/economia , Ensaios Clínicos como Assunto/métodos , Ensaios Clínicos como Assunto/organização & administração , Controle de Doenças Transmissíveis/métodos , Análise Custo-Benefício , Humanos , Risco Ajustado/métodos , Risco Ajustado/tendências , Medição de Risco/métodos , Gestão de Riscos/métodos , Gestão de Riscos/tendências , SARS-CoV-2 , Doença Relacionada a Viagens
8.
An. pediatr. (2003. Ed. impr.) ; 93(4): 267.e1-267.e9, oct. 2020. tab
Artigo em Espanhol | IBECS | ID: ibc-201505

RESUMO

El desarrollo de medicamentos para ciertas enfermedades raras puede verse truncado por la falta de financiación. En estos casos, en ocasiones, los propios pacientes -o sus familiares- financian el ensayo clínico en el que recibirán el medicamento experimental. Hay 3modelos de autofinanciación: 2de ellos, «pagar por probar» y «pagar por participar», ya se han puesto en práctica; el tercero, el modelo «plutocrático», que ha sido recientemente planteado, es, hasta la fecha, un modelo teórico. En este trabajo se repasan los beneficios y riesgos científicos, sociales y éticos de los 2modelos de investigación clínica: «pagar por participar» y el modelo «plutocrático». Una manera frecuente de poder autofinanciar estos ensayos clínicos es la obtención de fondos por micromecenazgo. Los aspectos más controvertidos de esta modalidad de financiación también son abordados en este trabajo desde diversas perspectivas. Por último, se plantea un escenario futuro que permitiera en nuestro país la puesta en marcha de estos ensayos clínicos autofinanciados mediante el modelo plutocrático


The development of medicines for certain rare diseases can be frustrated by lack of funding. In certain cases the patients themselves, or their relatives, occasionally fund the clinical trial in which they will be treated with the investigational medicine. There are 3models of self-funded research: 2of them, "pay to try" and "pay to participate", have already been put into practice. The third, the "plutocratic" proposal, which has been recently put forward is still a theoretical model. In this work the scientific, social and ethical benefits and risks of the 2clinical research models, "pay to participate" and the "plutocratic" proposal, are reviewed. Patient-funded clinical trials are frequently performed through crowdfunding. The most controversial aspects of this funding modality are also addressed in this article from several perspectives. Finally, a future scenario that would allow the launching of self-funded clinical trials in Spain by the "plutocratic" proposal is proposed


Assuntos
Humanos , Doenças Raras/epidemiologia , Financiamento de Capital/economia , Ensaios Clínicos como Assunto/economia , Pesquisa Biomédica/economia , Doenças Raras/terapia , Apoio à Pesquisa como Assunto/economia , Produção de Droga sem Interesse Comercial/economia , Pesquisa Biomédica/normas
10.
Pediatrics ; 146(4)2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-32943534

RESUMO

The National Institutes of Health's Environmental Influences on Child Health Outcomes (ECHO) program aims to study high-priority and high-impact pediatric conditions. This broad-based health initiative is unique in the National Institutes of Health research portfolio and involves 2 research components: (1) a large group of established centers with pediatric cohorts combining data to support longitudinal studies (ECHO cohorts) and (2) pediatric trials program for institutions within Institutional Development Awards states, known as the ECHO Institutional Development Awards States Pediatric Clinical Trials Network (ISPCTN). In the current presentation, we provide a broad overview of the ISPCTN and, particularly, its importance in enhancing clinical trials capabilities of pediatrician scientists through the support of research infrastructure, while at the same time implementing clinical trials that inform future health care for children. The ISPCTN research mission is aligned with the health priority conditions emphasized in the ECHO program, with a commitment to bringing state-of-the-science trials to children residing in underserved and rural communities. ISPCTN site infrastructure is critical to successful trial implementation and includes research training for pediatric faculty and coordinators. Network sites exist in settings that have historically had limited National Institutes of Health funding success and lacked pediatric research infrastructure, with the initial funding directed to considerable efforts in professional development, implementation of regulatory procedures, and engagement of communities and families. The Network has made considerable headway with these objectives, opening two large research studies during its initial 18 months as well as producing findings that serve as markers of success that will optimize sustainability.


Assuntos
Ensaios Clínicos como Assunto/organização & administração , Área Carente de Assistência Médica , Pediatria , Apoio à Pesquisa como Assunto/organização & administração , População Rural , Fortalecimento Institucional , Saúde da Criança , Ensaios Clínicos como Assunto/economia , Educação Continuada , Humanos , Apoio à Pesquisa como Assunto/economia , Estados Unidos
11.
PLoS One ; 15(9): e0239118, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32946474

RESUMO

INTRODUCTION: In 2012, bedaquiline became the first new treatment from a novel class to be approved for tuberculosis in nearly five decades and is now a core component of the standard of care for multidrug-resistant tuberculosis. In addition to the originator pharmaceutical company, Janssen, a range of governmental and non-profit entities have contributed to the development of bedaquiline. MATERIALS AND METHODS: We identified various avenues of public investments in the development of bedaquiline: direct funding of clinical trials and a donation programme, tax credits and deductions, and revenues resulting from the priority review voucher (PRV) awarded to the originator. Data on investments were gathered through contact with study leads and/or funders; for non-responses, published average costs were substituted. The originator company's expenses were estimated by similar methods. Tax credits and deductions were calculated based on estimated originator trial costs and donation expenses. The value of the PRV was estimated by application of a published model. RESULTS: Public contributions through clinical trials funding were estimated at US$109-252 million, tax credits at US$22-36 million, tax deductions at US$8-27 million, administration of a donation programme at US$5 million, PRV revenues at US$300-400 million. Total public investments were US$455-747 million and originator investments were US$90-240 million (if capitalized and risk-adjusted, US$647-1,201 million and US$292-772 million, respectively). CONCLUSIONS: Estimating the investments in the development of a medicine can inform discussions regarding fair pricing and future drug development. We estimated that total public investments exceeded the originator's by a factor of 1.6-5.1.


Assuntos
Antituberculosos/economia , Diarilquinolinas/economia , Desenvolvimento de Medicamentos/economia , Financiamento Governamental/economia , Organizações sem Fins Lucrativos/economia , Antituberculosos/uso terapêutico , Ensaios Clínicos como Assunto/economia , Diarilquinolinas/uso terapêutico , Custos de Medicamentos , Indústria Farmacêutica/economia , Humanos , Tuberculose Resistente a Múltiplos Medicamentos/tratamento farmacológico
13.
Cancer Discov ; 10(9): 1263-1266, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32669285
14.
Proc Natl Acad Sci U S A ; 117(24): 13386-13392, 2020 06 16.
Artigo em Inglês | MEDLINE | ID: mdl-32487730

RESUMO

Clinical research should conform to high standards of ethical and scientific integrity, given that human lives are at stake. However, economic incentives can generate conflicts of interest for investigators, who may be inclined to withhold unfavorable results or even tamper with data in order to achieve desired outcomes. To shed light on the integrity of clinical trial results, this paper systematically analyzes the distribution of P values of primary outcomes for phase II and phase III drug trials reported to the ClinicalTrials.gov registry. First, we detect no bunching of results just above the classical 5% threshold for statistical significance. Second, a density-discontinuity test reveals an upward jump at the 5% threshold for phase III results by small industry sponsors. Third, we document a larger fraction of significant results in phase III compared to phase II. Linking trials across phases, we find that early favorable results increase the likelihood of continuing into the next phase. Once we take into account this selective continuation, we can explain almost completely the excess of significant results in phase III for trials conducted by large industry sponsors. For small industry sponsors, instead, part of the excess remains unexplained.


Assuntos
Ensaios Clínicos como Assunto/economia , Ensaios Clínicos como Assunto/normas , Relatório de Pesquisa/normas , Pesquisa Biomédica/economia , Ensaios Clínicos como Assunto/estatística & dados numéricos , Desenvolvimento de Medicamentos/economia , Desenvolvimento de Medicamentos/organização & administração , Indústria Farmacêutica/economia , Humanos , Sistema de Registros , Apoio à Pesquisa como Assunto
15.
Int J Clin Oncol ; 25(7): 1207-1214, 2020 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-32577951

RESUMO

Investigator-led clinical trials are pragmatic trials that aim to investigate the benefits and harms of treatments in routine clinical practice. These much-needed trials represent the majority of all trials currently conducted. They are however threatened by the rising costs of clinical research, which are in part due to extensive trial monitoring processes that focus on unimportant details. Risk-based quality management focuses, instead, on "things that really matter". We discuss the role of central statistical monitoring as part of risk-based quality management. We describe the principles of central statistical monitoring, provide examples of its use, and argue that it could help drive down the cost of randomized clinical trials, especially investigator-led trials, whilst improving their quality.


Assuntos
Ensaios Clínicos como Assunto/estatística & dados numéricos , Oncologia/estatística & dados numéricos , Pesquisadores , Ensaios Clínicos como Assunto/economia , Ensaios Clínicos como Assunto/organização & administração , Humanos , Controle de Qualidade
16.
Farm Hosp ; 44(7): 66-70, 2020 06 13.
Artigo em Inglês | MEDLINE | ID: mdl-32533675

RESUMO

The health crisis resulting from the rapid spread of SARS-CoV-2 worlwide, added to the low evidence of currently used treatments has led to the development of a large number of clinical trials (CT) and observational studies. Likewise,  important measures have been adopted in healthcare and research centers  aimed at halting the pandemic as soon as possible. The objective of this study is  to gather the main aspects of the clinical research studies undertaken by the  Departments of Hospital Pharmacy (DHP) of Spain during the COVID-19 crisis. The decision of the Spanish Society of Hospital Pharmacy (SEFH) to sponsor CTs made it possible that 13% of DHP had been led at least one CT.  The Spanish Agency for Medicines and Medical Devices (AEMPS), in coordination  with Institutional Review Boards, has adopted a fast-track review procedure to  accelerate authorizations for CTs related to the treatment or prevention of  COVID-19. There have also been numerous public and private calls for financing  research projects aimed at contributing to the fight against this virus. Despite  the pandemic, actions have been taken to continue ongoing CTs and studies  while the safety and well-being of patients are guaranteed. More specifically, the AEMPS and the European Medicines Agency (EMA) have issued guidelines that  incorporate changes to CT protocols that will have to be applied until the  pandemic is over. In this health emergency, the scientific community has found  itself in a race against time to generate evidence. It is at this moment that  hospital pharmacists emerge as key players in clinical research and are  contributing to a rational, effective and safe healthcare decision-making.


Assuntos
Betacoronavirus , Ensaios Clínicos como Assunto , Infecções por Coronavirus/tratamento farmacológico , Controle de Infecções/organização & administração , Estudos Multicêntricos como Assunto , Estudos Observacionais como Assunto , Pandemias , Serviço de Farmácia Hospitalar/organização & administração , Pneumonia Viral/tratamento farmacológico , Antivirais/uso terapêutico , Ensaios Clínicos como Assunto/economia , Ensaios Clínicos como Assunto/estatística & dados numéricos , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/prevenção & controle , Tomada de Decisões , Drogas em Investigação/uso terapêutico , Previsões , Humanos , Estudos Multicêntricos como Assunto/economia , Estudos Multicêntricos como Assunto/estatística & dados numéricos , Estudos Observacionais como Assunto/economia , Estudos Observacionais como Assunto/estatística & dados numéricos , Pandemias/prevenção & controle , Segurança do Paciente , Pneumonia Viral/epidemiologia , Pneumonia Viral/prevenção & controle , Projetos de Pesquisa , Apoio à Pesquisa como Assunto , Papel (figurativo) , Espanha
17.
J Infect Dis ; 222(3): 356-361, 2020 07 06.
Artigo em Inglês | MEDLINE | ID: mdl-32469074

RESUMO

Trials are in development and underway to examine potential interventions for treatment and prophylaxis of coronavirus disease 2019 (COVID-19). How should we think about offering payment to participants in these trials? Payment for research participation is ethically contentious even under ideal circumstances. Here, we review 3 functions of research payment-reimbursement, compensation, and incentive-and identify heightened and novel ethical concerns in the context of a global pandemic. We argue that COVID-19 trial participants should usually be offered reimbursement for research-related expenses, and compensation for their time and effort, as for other types of research under usual circumstances. Given increased risk of undue influence against pandemic background conditions, incentive payment should be avoided unless essential to recruitment and retention in important trials whose social value outweighs this risk. Where essential, however, incentives can be ethically permissible, so long as reasonable efforts are made to minimize the possibility of undue influence.


Assuntos
Ensaios Clínicos como Assunto/economia , Infecções por Coronavirus/terapia , Voluntários Saudáveis , Pneumonia Viral/terapia , Ensaios Clínicos como Assunto/ética , Compensação e Reparação/ética , Infecções por Coronavirus/prevenção & controle , Humanos , Motivação/ética , Pandemias/prevenção & controle , Pneumonia Viral/prevenção & controle , Pesquisa/economia
SELEÇÃO DE REFERÊNCIAS
DETALHE DA PESQUISA
...