REGULATORY PUBLIC DISCLOSURE (RPD) - September
Below is a summary of the information shared this summer 2018 with those signed up to receive emails from the CORE Reference website (www.core-reference.org). To receive these updates in ‘real time’, join the mailing list at http://www.core-reference.org/subscribe
Interruption to EMA's clinical data publication activities
EMA Brexit preparedness is impacting broadly across EMA activities and this will specifically impact clinical data publication, for which the launch of new procedures will be temporarily suspended as of 1 August 2018. Data packages submitted for medicines until the end of July 2018 will be processed and finalised.
Are you using transcelerate's common protocol template?
If you are using TransCelerate's December 2017 version (current) of their Common Protocol Template, remember to consider including "estimand" in your protocol. Estimand is explained in ICH E9(R1) which is currently at Step 2 (draft guidance).
Merging Of EMA Portal and EU database planned for 2019
The European Commission (EC) is projecting that the EU Clinical Trial Regulation (CTR) 536/2014 will come into the application during 2019. This EC document presents the EU CTR updated time planning, including merging of EMA Portal and the EU database.
ATMPs Guidance – Stakeholder consultation
The European Commission has launched a targeted stakeholder consultation on their draft GCP guidelines for Advanced Therapy Medicinal Products (ATMPs). Access all the information on this dedicated EC webpage and submit your contributions by 31 October 2018.
CSRs in systematic reviews
Hodgkinson et al's 2018 manuscript entitled "The use of CSRs to enhance the quality of systematic reviews: a survey of systematic review authors" highlights the value of CSRs to the systematic review process and the perceived barriers to their use.
Policy 0070 Webinar
AMWA has released a free 'members only' recorded webinar entitled "Clinical Trial Transparency: What you need to know about EMA Policy 0070".
Clinical data publications in the first year of policy 0070
EMA has published their first report on the Policy 0070 publication of clinical data. The report provides information on the total number of documents published, the amount of commercially confidential information redacted and the anonymisation techniques used.
Data transparency and the non-commercial sector
DeVito et al's JAMA research letter show that non-commercial funders of clinical research have fallen behind the pharmaceutical industry in their promises on data transparency.