Regulation of Therapeutic Research is Compromising the Interests of Patients1

Chalmers, Iain

doi:10.2165/00124363-200721060-00004

Cited by 35 publications

(29 citation statements)

References 53 publications

(28 reference statements)

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“…There is little evidence that widely promoted forms of research regulation do more good than harm. 68 Informed consent procedures, like other well-intentioned public health interventions, should be assessed rigorously. The lethal effects we have shown might have been found decades ago had the research ethics community accepted a responsibility to provide robust evidence that its prescriptions are likely to do more good than harm.…”

Section: Consider For Crash 2 Trial Of Antifibrinolytic T R E a T M Ementioning

confidence: 99%

The CRASH-2 trial: a randomised controlled trial and economic evaluation of the effects of tranexamic acid on death, vascular occlusive events and transfusion requirement in bleeding trauma patients

Roberts

Shakur²,

Coats³

et al. 2013

Health Technol Assess

549

399

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Reports are published in Health Technology Assessment (HTA) if (1) they have resulted from work for the HTA programme, and (2) they are of a sufficiently high scientific quality as assessed by the reviewers and editors.Reviews in Health Technology Assessment are termed 'systematic' when the account of the search appraisal and synthesis methods (to minimise biases and random errors) would, in theory, permit the replication of the review by others. HTA programmeThe HTA programme, part of the National Institute for Health Research (NIHR), was set up in 1993. It produces high-quality research information on the effectiveness, costs and broader impact of health technologies for those who use, manage and provide care in the NHS. 'Health technologies' are broadly defined as all interventions used to promote health, prevent and treat disease, and improve rehabilitation and long-term care.The journal is indexed in NHS Evidence via its abstracts included in MEDLINE and its Technology Assessment Reports inform National Institute for Health and Clinical Excellence (NICE) guidance. HTA research is also an important source of evidence for National Screening Committee (NSC) policy decisions.For more information about the HTA programme please visit the website: http://www.hta.ac.uk/ This reportThe research reported in this issue of the journal was funded by the HTA programme as project number 06/303/20. The contractual start date was in April 2007. The draft report began editorial review in January 2012 and was accepted for publication in August 2012. The authors have been wholly responsible for all data collection, analysis and interpretation, and for writing up their work. The HTA editors and publisher have tried to ensure the accuracy of the authors' report and would like to thank the reviewers for their constructive comments on the draft document. However, they do not accept liability for damages or losses arising from material published in this report.This report presents independent research funded by the National Institute for Health Research (NIHR). The views and opinions expressed by authors in this publication are those of the authors and do not necessarily reflect those of the NHS, the NIHR, NETSCC, the HTA programme or the Department of Health. Background: Among trauma patients who survive to reach hospital, exsanguination is a common cause of death. A widely practicable treatment that reduces blood loss after trauma could prevent thousands of premature deaths each year. The CRASH-2 trial aimed to determine the effect of the early administration of tranexamic acid on death and transfusion requirement in bleeding trauma patients. In addition, the effort of tranexamic acid on the risk of vascular occlusive events was assessed.

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Section: Consider For Crash 2 Trial Of Antifibrinolytic T R E a T M Ementioning

confidence: 99%

The CRASH-2 trial: a randomised controlled trial and economic evaluation of the effects of tranexamic acid on death, vascular occlusive events and transfusion requirement in bleeding trauma patients

Roberts

Shakur²,

Coats³

et al. 2013

Health Technol Assess

549

399

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“…In this way, the current regulations are seriously inhibiting new research and can be considered unethical 16. The financial benefits that pharmaceutical companies obtain for extending their investigations into the paediatric age group will not improve the outlook for the majority of non-commercial trials 9.…”

Section: Resultsmentioning

confidence: 99%

Running an international paediatric non-commercial clinical trial

Osborne

O'Callaghan

2009

Archives of Disease in Childhood

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The current regulations for conducting non-commercial clinical trials in Europe are many and complex. These are explored from the perspective of a UK based non-commercial international clinical trial. The reasons for the difficulties encountered are discussed and suggestions made as to how best to overcome them. Improvements are suggested for our law makers and competent authorities. It is argued that the current regulatory environment could be considered unethical as it inhibits and delays research.

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“…They are a duty for physicians if they wish to offer optimal medical care. Because it is impossible to fulfill that duty without the means to do so, care trials should be promoted by regulation and health care organizations [25]. By controlling the use of well-intended but unvalidated interventions within care, care trials can improve health care efficiency.…”

Section: Discussionmentioning

confidence: 99%