The Value and Benefits of the International Conference on Harmonisation to Drug Regulatory Authorities: Advancing Harmonization for Better Public Health

Molzon, JA; Giaquinto, A; Lindström, Lars; Tominaga, Toshiyoshi; Ward, Monika A.; Doerr, Petra; Hunt, L C; Rägo, Lembit

doi:10.1038/clpt.2011.10

Cited by 36 publications

(26 citation statements)

References 3 publications

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“…Nevertheless, within our sample spanning different manufacturers, therapeutic classes and times, we found that the structure of CSRs was, within different house styles of presentation, strikingly similar, probably owing to the guidance by ICH E3. 25 This suggests that the structure and content of other CSRs is likely to be similar. 5…”

Section: Discussionmentioning

confidence: 99%

Clinical study reports of randomised controlled trials: an exploratory review of previously confidential industry reports

Doshi

Jefferson²

2013

BMJ Open

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ObjectiveTo explore the structure and content of a non-random sample of clinical study reports (CSRs) to guide clinicians and systematic reviewers.Search strategyWe searched public sources and lodged Freedom of Information requests for previously confidential CSRs primarily written by the industry for regulators.Selection criteriaCSRs reporting sufficient information for extraction (‘adequate’).Primary outcome measuresPresence and length of essential elements of trial design and reporting and compression factor (ratio of page length for CSRs compared to its published counterpart in a scientific journal).Data extractionData were extracted on standard forms and crosschecked for accuracy.ResultsWe assembled a population of 78 CSRs (covering 90 randomised controlled trials; 144 610 pages total) dated 1991–2011 of 14 pharmaceuticals. Report synopses had a median length of 5 pages, efficacy evaluation 13.5 pages, safety evaluation 17 pages, attached tables 337 pages, trial protocol 62 pages, statistical analysis plan 15 pages and individual efficacy and safety listings had a median length of 447 and 109.5 pages, respectively. While 16 (21%) of CSRs contained completed case report forms, these were accessible to us in only one case (765 pages representing 16 individuals). Compression factors ranged between 1 and 8805.ConclusionsClinical study reports represent a hitherto mostly hidden and untapped source of detailed and exhaustive data on each trial. They should be consulted by independent parties interested in a detailed record of a clinical trial, and should form the basic unit for evidence synthesis as their use is likely to minimise the problem of reporting bias. We cannot say whether our sample is representative and whether our conclusions are generalisable to an undefined and undefinable population of CSRs.

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Section: Discussionmentioning

confidence: 99%

Clinical study reports of randomised controlled trials: an exploratory review of previously confidential industry reports

Doshi

Jefferson²

2013

BMJ Open

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“…1 Especially because cancer is a life-threatening disease and a major cause of mortality, a lag in the timing of patient access to new oncology drugs is a serious problem. 2 To shorten the drug lag in Japan, the Japanese regulatory authority, the Pharmaceuticals and Medical Devices Agency (PMDA), has increased the number of full-time staff (to 820 in 2016 from 256 in 2004), 3 and the Ministry of Health, Labour and Welfare has released various guidelines including a revised guideline for the clinical evaluation of anticancer drugs in 2006, 4 notification about the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) E5 guideline, 5,6 Global Clinical Trials Guidance in 2007, 7,8 and guideline for first-in-human studies in 2012. 9 In addition, systems to promote the development have been enacted, such as the public knowledge-based new drug application and the Committee for Unapproved Drugs.…”

mentioning

confidence: 99%

Utilization of the Bridging Strategy for the Development of New Drugs in Oncology to Avoid Drug Lag

Kogure

Koyama

Hidaka

2017

The Journal of Clinical Pharma

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Global trial (GT) strategy and bridging (BG) strategy are currently the main clinical development strategies of oncology drugs in Japan, but the relationship between development style and drug lag and how the bridging strategy has contributed to the solution of drug lag have not been clear. We investigated the potential factors that influenced submission lag (SL), and also compared the differences in SL among early-initiation BG strategy, late-initiation BG strategy, and GT strategy. A stepwise linear regression analysis identified the potential factors that shorten SL: development start lag and development style. Comparison of the differences in SL among the strategies also indicated that the SL in the GT strategy and that in the early-initiation BG strategy were significantly shorter than that in the late-initiation BG strategy. The findings in our study suggest that the late-initiation BG strategy may not contribute to shortening drug lag. Because the number of late-initiation BG studies has not decreased, we propose first that pharmaceutical companies should initiate clinical development as early as possible in Japan so that they can choose the GT strategy as a first option at the next step, and second when they cannot choose the GT strategy after investigating differences in exposure between Japanese and non-Japanese in a phase 1 study, they should select the early BG strategy to avoid future drug lag. It is also important for the regulatory authorities to provide reasonable guidance to have a positive impact on strategic decisions, even for foreign-capital companies.

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“…38 Similar efforts are nascent in some developing regions, such as the East African Community's medicines registration harmonisation initiative…”

Section: Box 3: Some Global Initiatives Against Dangerously Compromismentioning

confidence: 99%

How to achieve international action on falsified and substandard medicines

Attaran

Barry

Basheer

et al. 2012

BMJ

125

134

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The Value and Benefits of the International Conference on Harmonisation to Drug Regulatory Authorities: Advancing Harmonization for Better Public Health

Cited by 36 publications

References 3 publications

Clinical study reports of randomised controlled trials: an exploratory review of previously confidential industry reports

Clinical study reports of randomised controlled trials: an exploratory review of previously confidential industry reports

Utilization of the Bridging Strategy for the Development of New Drugs in Oncology to Avoid Drug Lag

How to achieve international action on falsified and substandard medicines

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