The European Medicines Agency (EMA) announced on 3 March 2016 the publication of detailed guidance on the requirements for pharmaceutical companies to comply with the agency’s policy on publication of clinical trials data for medicines.
In April 2014, legislation was approved in Europe by the European Parliament, which aims to increase transparency with respect to clinical trials by making the results publicly available. EMA was commissioned by the European Parliament to create a database where all interested parties could view comprehensive data from clinical trials.
The transparency rules for the European Clinical Trial Regulation entered into force on 1 January 2015 and apply to clinical trial reports contained in all marketing authorization applications submitted on or after this date. The first reports will be published as soon as a decision on the application has been taken, currently foreseen for mid-2016.
This guidance aims to ensure that companies are aware of what is expected of them and that they are ready for the publication of these critical data.
External guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use
EMA/90915/2016
Date: 3 March 2016
The guidance consists of four chapters:
Chapter One contains information on the scope and definitions used throughout the text.
Chapter Two details procedural aspects on the submission of clinical reports including the concrete processes.
Chapter Three gives guidance to companies on how to anonymize clinical reports for the purpose of publication. The guidance does not single out one specific anonymization method yet gives recommendations to companies on how to best balance data utility for researchers with a minimal risk of re-identification. Companies will need to provide a report explaining their approach to the anonymization of the data, which will be reviewed and published by EMA.
Chapter Four focuses on the identification and redaction of commercially confidential information (CCI) in clinical reports submitted to EMA for the purpose of publication. The guidance makes clear that the vast majority of the information contained in clinical reports is not considered CCI. However, in the limited circumstances in which clinical reports might contain CCI, companies will need to submit to EMA for review a table justifying why such data has been redacted. The guidance clarifies which type of data EMA would typically refuse as being CCI and how the redaction of such data will be handled.
EMA has been criticized in the past for its redaction of data, in particular in the case of clinical study reports for AbbVie’s arthritis blockbuster Humira (adalimumab) [1, 2].
EMA says that this detailed set of guidance has been finalized following an extensive consultation with all stakeholders concerned throughout 2015. This included a public consultation on how the transparency rules would be applied, for which the closing date for comments was 18 February 2015, and a webinar, which was held on 24 June 2015 [3].
Related article
EMA explains redaction of AbbVie’s data
References
1. GaBI Online - Generics and Biosimilars Initiative. EMA criticized for redaction of AbbVie’s data [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Mar 11]. Available from: www.gabionline.net/Policies-Legislation/EMA-criticized-for-redaction-of-AbbVie-s-data
2. GaBI Online - Generics and Biosimilars Initiative. EMA’s clinical transparency rules come under fire [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Mar 11]. Available from: www.gabionline.net/Policies-Legislation/EMA-s-clinical-transparency-rules-come-under-fire
3. GaBI Online - Generics and Biosimilars Initiative. EMA to hold webinar on publication of clinical trials data [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Mar 11]. Available from: www.gabionline.net/Policies-Legislation/EMA-to-hold-webinar-on-publication-of-clinical-trials-data
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