"Only in research"
Whether a fully supportive decision, instead of an "only in research" recommendation, would lead to the termination of research in progress or prevent new research from beginning and thus have a negative impact on future collection of relevant information
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| Corporate Authors: | , |
| Format: | eBook |
| Language: | English |
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London
National Institute for Health and Clinical Excellence (NICE)
2007, 2007
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| Series: | Citizens Council reports
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| Subjects: | |
| Online Access: | |
| Collection: | National Center for Biotechnology Information - Collection details see MPG.ReNa |
| Summary: | Whether a fully supportive decision, instead of an "only in research" recommendation, would lead to the termination of research in progress or prevent new research from beginning and thus have a negative impact on future collection of relevant information recruitment to the study is open, and is expected to last at least 1 year beyond the guidance publication date); or 3. could be established quickly; 2. Whether the question addressed by the study will contribute to reducing the uncertainties identified during the preparation of NICE guidance; 3. Whether the research is feasible (in terms of numbers of patients, recruitment etc.) and is likely to deliver results within an appropriate time period; 4. Whether the study will be multi-centre with broad coverage of geographical area and population to ensure that as many eligible patients as possible can realistically access the technology within a study setting; 5. Whether further research is good value for money 6. Whether a fully supportive decision, would lead to significant irretrievable fixed costs of implementation; and 7. The Citizens Council provides NICE with a public perspective on overarching moral and ethical issues that NICE should take into account when producing guidance. Made up of members of the public, broadly representative of the adult UK population, the Council operates through a "citizens' jury" style meeting, to explore and respond to a question set by NICE. At the January 2007 meeting of the Council, members were asked to consider the following question: In what circumstances is it justified for NICE to recommend that an intervention is used only in the context of research? NICE exists to develop guidance for the NHS and the wider public health community, based on the available evidence. However, there are often "gaps" in the evidence that NICE reviews. Where NICE has been able to recommend an intervention for use despite some gaps in the evidence, such gaps are usually identified in a set of 'Recommendations for Further Research' which follow the main guidance. However, as well as making recommendations for further research of interventions which it supports, NICE has sometimes recommended that interventions only be available in the NHS as part of a research programme (i.e. "only in research"). The additional evidence gathered by this research will then be used when NICE reviews its guidance. This approach has been used when promising interventions have not yet been supported by sufficiently robust evidence to justify an unqualified recommendation. The Council was asked to consider both potential risks and potential benefits to various types of stakeholders of using the 'only in research' option, as well as other matters that might affect the appropriateness of an 'only in research' recommendation such as: 1. Whether at least one appropriate, relevant study is either: 1. planned (e.g. the study will definitely start within 6 months of the guidance publication date); 2. in progress (e.g. |
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| Item Description: | "Ela Pathak-Sen, Brendan Turner, Helen Bidwell and Jessica Abell of Vision 21 facilitated the NICE Citizens Council meeting. Geoff Watts wrote this report on behalf of the Citizens Council"-- Page 2 |
| Physical Description: | 1 PDF file (41 pages) illustrations, portrait |