EMA to hold webinar on publication of clinical trials data

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EMA to hold webinar on publication of clinical trials data

INICIO/Políticas y legislación | Posted 12/06/2015 0 Post your comment

The European Medicines Agency (EMA) has announced that it will hold a webinar on its policy concerning the publication of clinical trials data.

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 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.

EMA has, however, been criticized for its redaction of AbbVie’s data [1]. The German Institute for Quality and Efficiency in Health Care (IQWiG) has also raised concerns, stating that ‘the decision to keep the data secret is, more or less, left to those who carry out the studies’ and that ‘manufacturers who wish to black-out records, must in each case justify their reasons to EMA and the agency must examine the justifications meticulously’ [2].

EMA has already held a public consultation on how the transparency rules will be applied, for which the closing date for comments was 18 February 2015. Now for this webinar, which will be held on 24 June 2015, the agency will cover the following topics:

an explanation of the principles for the submission of redacted clinical reports
the redaction consultation process
guidance on what is and is not considered commercially confidential information
anonymization and redaction of personal data in clinical reports

The webinar will be broadcast live on the EMA website. Individuals wishing to participate in the webinar should register their interest by sending an email with their contact details to clinicaldatapolicywebinar@ema.europa.eu by 19 June 2015.

EMA is also planning a face-to-face meeting, which will be held on 6 July 2015 to allow more detailed discussions on the guidance on anonymization and redaction of personal data and on what is not considered commercially confidential information.

Related articles
EMA explains redaction of AbbVie’s data

EMA changes transparency plans to increase access to 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 2015 Jun 12]. 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 2015 Jun 12]. Available from: www.gabionline.net/Policies-Legislation/EMA-s-clinical-transparency-rules-come-under-fire

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Source: EMA