Dataset Information

Financial interests of patient organisations contributing to technology assessment at England's National Institute for Health and Care Excellence: policy review.

ABSTRACT:

Objective

To investigate the prevalence of financial interests among patient organisations contributing to health technology assessment at the National Institute for Health and Care Excellence (NICE) in England and the extent to which NICE's disclosure policy ensures that decision making committees are aware of these interests.

Design

Policy review using accounts, annual reports, and websites of patient organisations; payments declared by pharmaceutical manufacturers on their websites and a centralised database (Disclosure UK); declarations of interests by nominated representatives of patient organisations; and responses from patient organisations.

Setting

Appraisals of medicines and treatments (technologies) for use in the English and Welsh National Health Service.

Participants

53 patient organisations contributing to 41 NICE technology appraisals published in 2015 and 2016, with 117 separate occasions that a patient organisation contributed to the appraisal of a technology.

Main outcome measures

Prevalence of specific interests (that is, funding from manufacturer(s) of a technology under appraisal or competitor products); proportion of specific interests of which NICE's decision making committees were aware; proportion of unknown specific interests for which disclosure was not required by NICE's policy RESULTS: 38/53 (72%) patient organisations had accepted funding from the manufacturer(s) of a technology or a competitor product in the same year that they had contributed to the appraisal of that technology or the previous year. Specific interests were present on 92/117 (79%) occasions that patient organisations contributed to appraisals in 2015 and 2016. NICE's decision making committees were aware of less than a quarter of specific interests (30/144; 21%). For nearly two thirds of the specific interests not known to committees (71/114; 62%), disclosure by patient organisations was not required by NICE's policy.

Conclusions

Financial interests are highly prevalent among patient organisations contributing to health technology assessment. NICE should review its disclosure policy to ensure that decision making committees are aware of all relevant interests.

SUBMITTER: Mandeville KL

PROVIDER: S-EPMC6334181 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

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Publications

Financial interests of patient organisations contributing to technology assessment at England's National Institute for Health and Care Excellence: policy review.

Mandeville Kate L KL Barker Rosie R Packham Alice A Sowerby Charlotte C Yarrow Kielan K Patrick Hannah H

BMJ (Clinical research ed.) 20190116

<h4>Objective</h4>To investigate the prevalence of financial interests among patient organisations contributing to health technology assessment at the National Institute for Health and Care Excellence (NICE) in England and the extent to which NICE's disclosure policy ensures that decision making committees are aware of these interests.<h4>Design</h4>Policy review using accounts, annual reports, and websites of patient organisations; payments declared by pharmaceutical manufacturers on their webs ...[more]

PMID: 30651227

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Project description:Importance:One major advantage of developing large, federally funded networks for clinical research in neurology is the ability to have a trial-ready network that can efficiently conduct scientifically rigorous projects to improve the health of people with neurologic disorders. Observations:National Institute of Neurological Disorders and Stroke Network for Excellence in Neuroscience Clinical Trials (NeuroNEXT) was established in 2011 and renewed in 2018 with the goal of being an efficient network to test between 5 and 7 promising new agents in phase II clinical trials. A clinical coordinating center, data coordinating center, and 25 sites were competitively chosen. Common infrastructure was developed to accelerate timelines for clinical trials, including central institutional review board (a first for the National Institute of Neurological Disorders and Stroke), master clinical trial agreements, the use of common data elements, and experienced research sites and coordination centers. During the first 7 years, the network exceeded the goal of conducting 5 to 7 studies, with 9 funded. High interest was evident by receipt of 148 initial applications for potential studies in various neurologic disorders. Across the first 8 studies (the ninth study was funded at end of initial funding period), the central institutional review board approved the initial protocol in a mean (SD) of 59?(21) days, and additional sites were added a mean (SD) of 22?(18) days after submission. The median time from central institutional review board approval to first site activation was 47.5 days (mean,?102.1; range,?1-282) and from first site activation to first participant consent was 27 days (mean,?37.5; range,?0-96). The median time for database readiness was 3.5 months (mean,?4.0; range,?0-8) from funding receipt. In the 4 completed studies, enrollment met or exceeded expectations with 96% overall data accuracy across all sites. Nine peer-reviewed manuscripts were published, and 22 oral presentations or posters and 9 invited presentations were given at regional, national, and international meetings. Conclusions and Relevance:NeuroNEXT initiated 8 studies, successfully enrolled participants at or ahead of schedule, collected high-quality data, published primary results in high-impact journals, and provided mentorship, expert statistical, and trial management support to several new investigators. Partnerships were successfully created between government, academia, industry, foundations, and patient advocacy groups. Clinical trial consortia can efficiently and successfully address a range of important neurologic research and therapeutic questions.

Dataset Information

Financial interests of patient organisations contributing to technology assessment at England's National Institute for Health and Care Excellence: policy review.

Objective

Design

Setting

Participants

Main outcome measures

Conclusions

Publications

Financial interests of patient organisations contributing to technology assessment at England's National Institute for Health and Care Excellence: policy review.

Similar Datasets

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