Wissenschaftsbezogene Ethikinitiativen supra-/nationaler Organisationen im europäischen Forschungsraum

Blumenthal, Sara

doi:10.7767/boehlau.9783205791065.149

Cited by 6 publications

(3 citation statements)

References 6 publications

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“…Rather, its statutorily authorized activities were aimed at knowledge development and processing. 206 However, the Center was perceived by some as having a regulatory or quasi-regulatory role because of its authority to advise the Secretary of DHHS on reimbursement policy. 207 Through this authority, NCHCT influenced coverage decisions for publicly funded health programs.…”

Section: National Center For Health Care Technologymentioning

confidence: 99%

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The History of Technology Assessment and Comparative Effectiveness Research for Drugs and Medical Devices and the Role of the Federal Government

Wong¹

2014

Biotechnology Law Report

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See Banta, supra n.15, at 124 (noting that during the 1990s, almost all member states of the European Union had national and regional HTA agencies or programs); Luce et al., supra n. 19 at 258; Sullivan et al., supra n. 8 at S39 (indicating that Australia [Pharmaceutical Benefits Advisory Committee], Canada [Canadian Agency for Drugs ad Technologies in Health], Sweden [Swedish Council on Technology Assessment in Health Care], and the United Kingdom [National Institute for Health and Clinical Excellence] all have national HTA programs).

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Section: National Center For Health Care Technologymentioning

confidence: 99%

“…Even though NCHCT's authorized budget was for $73 million over 3 years, Congress appropriated only $7.8 million for it during that time. 233 Furthermore, the Center's congressional allocation of staff never exceeded 20. 234 The NCHCT's authorization expired at the end of the fiscal year 1981.…”

Section: National Center For Health Care Technologymentioning

confidence: 99%

The History of Technology Assessment and Comparative Effectiveness Research for Drugs and Medical Devices and the Role of the Federal Government

Wong¹

2014

Biotechnology Law Report

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“…Recent changes, which were clearly needed, include the strong movement towards a clinical trials registry and an insistence that researchers maintain access to clinical trials data and the right to publish trial results without interference by the funder. 69 Top-tier medical journals now demand that clinical trials be registered. 70 Many now expect authors to disclose whether they controlled decisions about how to analyze and report the data.…”

Section: What Should Be Done?mentioning

confidence: 99%

Better Regulation of Industry-Sponsored Clinical Trials is Long Overdue

Wynia

Boren

2009

J. Law. Med. Ethics

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Regulating clinical trials for testing new drugs is fraught with risk. Misregulation can slow development of innovative and useful new drugs, but in other ways misregulation can foster trials that are inefficient and unethical, driven by commercial rather than scientific ends, and that can harm patients. In this paper, we argue not for more but for better regulation, based on the goal of rapidly producing innovative and safe products that represent significant advances in medical care. Data on industry-funded, late-stage clinical trials demonstrate an urgent need for dramatic changes in how these trials are designed, conducted, and analyzed. On the one hand, current patent rules can dissuade development of innovative new products with smaller markets and press trial designers to create positive results too rapidly. But at the same time, numerous studies show that when the pharmaceutical industry sponsors clinical trials, the results are systematically biased in favor of the sponsor's product, often to the detriment of patients and the public. The reasons for this bias are both complex and unavoidable, and the ways in which clinical trial design, conduct, and reporting can be inappropriately influenced are so varied and nuanced, that efforts to manage this conflict of interest and prevent harms are inevitably unsuccessful. Instead, we conclude such conflict should be avoided and a strong firewall should exist between drug developers and the final stages of clinical testing in humans. All financial support for phase III clinical trials should pass through a public-private partnership organization--perhaps tied to a broader clinical effectiveness research enterprise--which would be charged with designing, funding, and monitoring late-stage human clinical trials of new pharmaceutical products.

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What is (and Isn't) Healthism

Roberts

Leonard

2015

SSRN Journal

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Wissenschaftsbezogene Ethikinitiativen supra-/nationaler Organisationen im europäischen Forschungsraum

Cited by 6 publications

References 6 publications

The History of Technology Assessment and Comparative Effectiveness Research for Drugs and Medical Devices and the Role of the Federal Government

The History of Technology Assessment and Comparative Effectiveness Research for Drugs and Medical Devices and the Role of the Federal Government

Better Regulation of Industry-Sponsored Clinical Trials is Long Overdue

What is (and Isn't) Healthism

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