Your browser doesn't support javascript.
loading
Mostrar: 20 | 50 | 100
Resultados 1 - 20 de 84
Filtrar
3.
Contemp Clin Trials ; 85: 105831, 2019 10.
Artigo em Inglês | MEDLINE | ID: mdl-31445173

RESUMO

Legally effective informed consent has been a long-standing requirement for FDA-regulated clinical studies. However, informed consent forms (ICFs) are often thought to be too long, too complex, and too difficult for participants to understand. In this article, investigators from the FDAs Center for Devices and Radiological Health (CDRH) surveyed 399 ICFs from approved investigational device exemption (IDE) applications for fiscal years 2015 and 2016 to evaluate the readability of ICFs. The investigators collected data from the ICFs, using variables related to structure, readability, and comprehension. The investigators found that the mean grade-reading levels of the ICFs ranged from 10th grade to college level (Table 2), higher than the recommended 6th to 8th grade level, when measured by major readability evaluation tools (the SMOG readability grade level formula, the Flesch-Kincaid Index Grade Level Readability Formula, the Flesch Reading Ease test, and the Dale-Chall readability formula). Overall, the ICFs and informed consent (IC) processes, as described in the IDE application, lacked components that enhanced participants' comprehension, such as short sentences (e.g., no more than 8 to 10 to words) and the use of pictures, tables, and diagrams. CDRH investigators believe that information about ICFs' readability, comprehension, and structure will help support current and future efforts to improve the IC process. The intent of the article is to demonstrate that improvements are needed in the IC process and to encourage clinical trial stakeholders to consider implementing those approaches that optimize patient comprehension in the development of their IC processes.


Assuntos
Termos de Consentimento/normas , Equipamentos e Provisões , Ensaios Clínicos Controlados Aleatórios como Assunto/ética , United States Food and Drug Administration/normas , Compreensão , Equipamentos e Provisões/ética , Humanos , Consentimento Livre e Esclarecido/psicologia , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Ensaios Clínicos Controlados Aleatórios como Assunto/normas , Sujeitos da Pesquisa/psicologia , Inquéritos e Questionários , Estados Unidos , United States Food and Drug Administration/ética
8.
PLoS Biol ; 15(12): e2003578, 2017 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-29261673

RESUMO

The American diet has changed dramatically since 1958, when Congress gave the United States Food and Drug Administration (FDA) the authority to ensure the safety of chemicals in food. Since then, thousands of chemicals have entered the food system. Yet their long-term, chronic effects have been woefully understudied, their health risks inadequately assessed. The FDA has been sluggish in considering scientific knowledge about the impact of exposures-particularly at low levels and during susceptible developmental stages. The agency's failure to adequately account for the risks of perchlorate-a well-characterized endocrine-disrupting chemical-to vulnerable populations is representative of systemic problems plaguing the regulation of chemicals in food. Today, we are faced with a regulatory system that, weakened by decades of limited resources, has fallen short of fully enforcing its mandates. The FDA's inability to effectively manage the safety of hundreds of chemicals is putting our children's health at risk.


Assuntos
Análise de Alimentos/ética , Inocuidade dos Alimentos , Política de Saúde , United States Food and Drug Administration/legislação & jurisprudência , Disruptores Endócrinos/isolamento & purificação , Disruptores Endócrinos/toxicidade , Análise de Alimentos/economia , Análise de Alimentos/métodos , Humanos , Percloratos/isolamento & purificação , Percloratos/toxicidade , Estados Unidos , United States Food and Drug Administration/ética
10.
Indian J Med Ethics ; 2(3): 194-199, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-28812979

RESUMO

This report describes the background and context of a currently circulating petition to the US Congress that seeks amendment of Section 801 of the Public Health Services Act (42 U.S.C. 282) to close a loophole in existing law which makes possible post hoc adjustment of randomised controlled trial (RCT) results reported to the Food and Drug Administration that differ from those reported to ClinicalTrials.gov and to medical journals. The report describes the petition's rationale, underlying assumptions, and support for its proposed remedy in deontological, consequentialist, and casuist philosophical ethics theories. It addresses the several reservations of the World Association of Medical Editors (WAME) with citations of evidence for the petition's assertions. The report suggests that some medical journals are not unknowing victims but rather complicit enablers of the post hoc adjusted RCT results that they publish. Its closing remarks dwell on the negative impact that embrace of a neoliberal, anti-regulatory philosophy of government will likely have on any regulatory reform to promote the integrity of biomedical science and the future of evidence-based medicine.


Assuntos
Pesquisa Biomédica/legislação & jurisprudência , Decepção , Revelação , Fraude , Regulamentação Governamental , Editoração/legislação & jurisprudência , United States Food and Drug Administration/legislação & jurisprudência , Pesquisa Biomédica/ética , Políticas Editoriais , Teoria Ética , Ética em Pesquisa , Medicina Baseada em Evidências , Humanos , Legislação Médica , Editoração/ética , Ensaios Clínicos Controlados Aleatórios como Assunto/ética , Ensaios Clínicos Controlados Aleatórios como Assunto/legislação & jurisprudência , Relatório de Pesquisa/legislação & jurisprudência , Estados Unidos , United States Food and Drug Administration/ética
16.
Account Res ; 23(5): 257-79, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-26890488

RESUMO

The relationships among academe, publishing, and industry can facilitate commercial bias in how drug efficacy and safety data are obtained, interpreted, and presented to regulatory bodies and prescribers. Through a critique of published and unpublished trials submitted to the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for approval of a new antidepressant, vortioxetine, we present a case study of the "ghost management" of the information delivery process. We argue that currently accepted practices undermine regulatory safeguards aimed at protecting the public from unsafe or ineffective medicines. The economies of influence that may intentionally and unintentionally produce evidence-biased-rather than evidence-based-medicine are identified. This is not a simple story of author financial conflicts of interest, but rather a complex tale of ghost management of the entire process of bringing a drug to market. This case study shows how weak regulatory policies allow for design choices and reporting strategies that can make marginal products look novel, more effective, and safer than they are, and how the selective and imbalanced reporting of clinical trial data in medical journals results in the marketing of expensive "me-too" drugs with questionable risk/benefit profiles. We offer solutions for neutralizing these economies of influence.


Assuntos
Conflito de Interesses , Indústria Farmacêutica/organização & administração , Legislação de Medicamentos/organização & administração , Editoração/organização & administração , United States Food and Drug Administration/organização & administração , Antidepressivos/uso terapêutico , Viés , Indústria Farmacêutica/ética , Europa (Continente) , Humanos , Piperazinas/uso terapêutico , Editoração/ética , Sulfetos/uso terapêutico , Estados Unidos , United States Food and Drug Administration/ética , Vortioxetina
17.
BMC Med Ethics ; 16(1): 75, 2015 Nov 04.
Artigo em Inglês | MEDLINE | ID: mdl-26537611

RESUMO

BACKGROUND: In 2004, patient advocate groups were major players in helping pass and implement significant public policy and funding initiatives in stem cells and regenerative medicine. In the following years, advocates were also actively engaged in Washington DC, encouraging policy makers to broaden embryonic stem cell research funding, which was ultimately passed after President Barack Obama came into office. Many advocates did this because they were told stem cell research would lead to cures. After waiting more than 10 years, many of these same patients are now approaching clinics around the world offering experimental stem cell-based interventions instead of waiting for scientists in the US to complete clinical trials. How did the same groups who were once (and often still are) the strongest supporters of stem cell research become stem cell tourists? And how can scientists, clinicians, and regulators work to bring stem cell patients back home to the US and into the clinical trial process? DISCUSSION: In this paper, we argue that the continued marketing and use of experimental stem cell-based interventions is problematic and unsustainable. Central problems include the lack of patient protection, US liability standards, regulation of clinical sites, and clinician licensing. These interventions have insufficient evidence of safety and efficacy; patients may be wasting money and time, and they may be forgoing other opportunities for an intervention that has not been shown to be safe and effective. Current practices do not contribute to scientific progress because the data from the procedures are unsuitable for follow-up research to measure outcomes. In addition, there is no assurance for patients that they are receiving the interventions promised or of what dosage they are receiving. Furthermore, there is inconsistent or non-existent follow-up care. Public policy should be developed to correct the current situation. CONCLUSION: The current landscape of stem cell tourism should prompt a re-evaluation of current approaches to study cell-based interventions with respect to the design, initiation, and conduct of US clinical trials. Stakeholders, including scientists, clinicians, regulators and patient advocates, need to work together to find a compromise to keep patients in the US and within the clinical trial process. Using HIV/AIDS and breast cancer advocate cases as examples, we identify key priorities and goals for this policy effort.


Assuntos
Neoplasias da Mama/terapia , Terapia Baseada em Transplante de Células e Tecidos/ética , Infecções por HIV/terapia , Turismo Médico/ética , Medicina Regenerativa , Transplante de Células-Tronco/ética , United States Food and Drug Administration/ética , Neoplasias da Mama/epidemiologia , Neoplasias da Mama/genética , Predisposição Genética para Doença , Regulamentação Governamental , Infecções por HIV/epidemiologia , Infecções por HIV/genética , Política de Saúde , Humanos , Turismo Médico/estatística & dados numéricos , Medicina Regenerativa/ética , Medicina Regenerativa/tendências , Estados Unidos/epidemiologia
18.
Value Health ; 18(5): 682-9, 2015 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-26297097

RESUMO

BACKGROUND: Section 114 of the Food and Drug Administration Modernization Act of 1997 regulates the promotion of health economic information by pharmaceutical companies to US health plans. Greater clarity is important given demands by payers and other stakeholders for evidence of value. OBJECTIVES: To develop hypothetical case studies of health economic promotions to examine legal and policy implications. METHODS: We constructed for pedagogical purposes 10 categories of potential health economic promotions. We generated hypothetical case studies for each category, including questions about whether each might be allowable under Section 114. The case studies were developed around the following categories: 1) costing out on-label clinical end points; 2) promotion of a costing exercise to physicians working in an accountable care organization setting; 3) burden-of-illness claims; 4) economic analysis of a formulary restriction policy; 5) extrapolations to doses, populations, or settings not covered in trials; 6) adherence claims; 7) "utilization of care" as a secondary end point in randomized clinical trials; 8) costing out a competitor drug's adverse event; 9) economic analysis of comparative effectiveness claims using an indirect treatment comparison; and 10) extrapolating from surrogate to long-term outcomes in an economic model. DISCUSSION: Most cases seem to fall into a gray zone given haziness around what constitutes "competent and reliable evidence" and "directly relate[d]" to an approved indication. In practice, it is difficult to know what the section allows given the imprecision of the statute and lack of guidance about its scope. CONCLUSION: Ideally, future guidance will provide clarity and flexibility.


Assuntos
Publicidade/legislação & jurisprudência , Indústria Farmacêutica/legislação & jurisprudência , Sistemas de Informação em Saúde/legislação & jurisprudência , Política de Saúde/legislação & jurisprudência , Seguro Saúde/legislação & jurisprudência , Marketing de Serviços de Saúde/legislação & jurisprudência , United States Food and Drug Administration/legislação & jurisprudência , Publicidade/economia , Publicidade/ética , Pesquisa Comparativa da Efetividade/legislação & jurisprudência , Conflito de Interesses , Redução de Custos , Análise Custo-Benefício , Custos de Medicamentos/legislação & jurisprudência , Indústria Farmacêutica/economia , Indústria Farmacêutica/ética , Medicina Baseada em Evidências/legislação & jurisprudência , Formulários Farmacêuticos como Assunto , Sistemas de Informação em Saúde/economia , Sistemas de Informação em Saúde/ética , Política de Saúde/economia , Humanos , Seguro Saúde/economia , Seguro Saúde/ética , Relações Interinstitucionais , Marketing de Serviços de Saúde/economia , Marketing de Serviços de Saúde/ética , Anos de Vida Ajustados por Qualidade de Vida , Revelação da Verdade , Estados Unidos , United States Food and Drug Administration/economia , United States Food and Drug Administration/ética
SELEÇÃO DE REFERÊNCIAS
DETALHE DA PESQUISA