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Maximising success through strategic partnerships

Maximising success through strategic partnerships
pharmatimes.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from pharmatimes.com Daily Mail and Mail on Sunday newspapers.

United Kingdom , David Turner , Mai Yee Mishir , European Medicines Agency , Global Safety Services At Advance Clinical , Global Regulatory Affairs , Divergent Regulatory Requirements , Informed Consent Form , Clinical Trial Information System , Yee Mishir , Senior Director , Global Safety Services ,

Availability of results of clinical trials registered on EU Clinical Trials Register: cross sectional audit study

Objective To identify the availability of results for trials registered on the European Union Clinical Trials Register (EUCTR) compared with other dissemination routes to understand its value as a results repository.

Design Cross sectional audit study.

Setting EUCTR protocols and results sections, data extracted 1-3 December 2020.

Population Random sample of 500 trials registered on EUCTR with a completion date of more than two years from the beginning of searches (ie, 1 December 2018).

Main outcome measures Proportion of trials with results across the examined dissemination routes (EUCTR, ClinicalTrials.gov, ISRCTN registry, and journal publications), and for each dissemination route individually. Prespecified secondary outcomes were number and proportion of unique results, and the timing of results, for each dissemination route.

Results In the sample of 500 trials, availability of results on EUCTR (53.2%, 95% confidence interval 48.8% to 57.6%) ....

United Kingdom , International Clinical Trials Registry Platform , Python Software Foundation , European Medicines Agency , European Union Clinical Trials Register , Trial Regulation , Clinical Trial Information System , Open Science Framework , Open Science , Jupyter Notebook , Pandas Python , Google Scholar , European Economic Area , Bennett Institutes , Applied Data Science ,

Clinical Trial Disclosure Compliance A Moving Target Due To Ever-Changing Global Regulations

Clinical Trial Disclosure Compliance A Moving Target Due To Ever-Changing Global Regulations
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European Medicines Agency , Trialscope Intelligence , Clinical Trial Information System ,