September 2020

1 - EMA to disclose COVID-19 clinical data

In the June 2020 EMA Management Board Meeting Report, we learned that EMA plan to publish COVID-19 clinical data, although there is no publication timeframe indicated.

Page 4 of the report states:

"In the unprecedented fast track approval scenario, the public needs to be assured of the quality of the evidence behind the regulatory decisions. EMA proposes to publish a number of documents for COVID-19 products, and to resume for them the publication of clinical data, which is currently on hold due to the Business Continuity Plan (BCP)".

What this means for Sponsors is that it would be wise to plan public disclosure activities for COVID-19 CSRs intended for EMA submissions.

Download CORE Reference (https://www.core-reference.org/core-reference/) which is now approaching 28.5k downloads - as your tool to proactively author the regulatory review version CSR so that you have minimal redactions to make in the public disclosure version CSR.

That plan went into action in mid-September:

Exceptional transparency measures are now in place for COVID-19 treatments and vaccines. Clinical data (i.e., CSRs and clinical summary documents) will be published on EMA's clinical data publication page for COVID-19 vaccines and therapeutics that are granted a license.

2 - UK seeks to register and report 100% of clinical trials

TranspariMed reports that: "The UK is poised to become the first country worldwide to ensure that all clinical trials are registered and report their results, with clinical trials being registered centrally and a government agency monitoring whether their results have been made public".