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When I use a word . . . Commercial clinical trials
The BMJ ( IF 105.7 ) Pub Date : 2023-05-30 , DOI: 10.1136/bmj.p1223 Jeffrey K Aronson 1, 2
The BMJ ( IF 105.7 ) Pub Date : 2023-05-30 , DOI: 10.1136/bmj.p1223 Jeffrey K Aronson 1, 2
Affiliation
A new report on the conduct of commercially sponsored clinical trials of new medications has just been published. It contains 27 recommendations. The UK government has welcomed all of them, and has promised to fund five. Important features of such trials that are not mentioned in the report include methods for improving and measuring participant adherence to an intervention and methods for detecting harms. Earlier this year, the UK government appointed Lord James O’Shaughnessy, senior partner at a consultancy firm, Newmarket Strategy, a board member of Health Data Research UK, and a former Conservative health minister, to conduct an independent review into what was described as “the UK commercial clinical trials landscape.”1 The background to this review was that there had reportedly been a 44% fall in recruitment of patients to phase 3 commercial clinical trials between 2017 and 2021. This had had the effect, according to an analysis by the Association of the British Pharmaceutical Industry (ABPI), of dropping the UK down the global rankings for numbers of phase 3 industry sponsored clinical trials from fourth place in 2017, after the USA, Germany, and Spain, to 10th in 2021, now behind the USA, China, Spain, Japan, Germany, Canada, France, Poland, and Italy.2 This was despite the fact that during the same time the UK had risen from fourth to third place in regard to phase 1 trials and from 10th to second in regard to phase 2 trials. The implication was that there were difficulties in recruiting patients to the phase 3, so-called pivotal, trials that companies use in applying to regulatory authorities for marketing authorisations. However, rather than analysing the raw numbers of trials being carried out in each country at each …
更新日期：2023-05-31
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