Posted on 10 Oct 2018

REGULATORY PUBLIC DISCLOSURE (RPD) - October

FDA Guidance Documents

  1. In September 2018, FDA issued draft guidance titled “Civil Money Penalties Relating to the CT.gov Data Bank” describing FDA thinking on financial penalties against Sponsors of clinical trials who do not register and/or submit results information to CT.gov.

     

  2. Clinical study protocols are publicly disclosed documents, making the following September 2018 draft FDA guidance releases on protocol development relevant
    1. 'Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics - Guidance for Industry’
    2. 'Adaptive Designs for Clinical Trials of Drugs and Biologics - Guidance for Industry’

Developments in Europe

  1. The European Commission (EC) issued a Notice to Stakeholders on 06 September 2018 titled "Withdrawal of the UK and EU rules in the field of clinical trials". The Notice explains how the supply of investigational medicinal products, the establishment of the Sponsor's legal representative, and submission of clinical trial information to EudraCT are impacted by the UK's withdrawal (due on 30 March 2019) from the EU. The EU CT web page will be updated with further information as necessary.
  2. EMA is compiling a report listing those Sponsors on EudraCT who are not compliant with results posting requirements. The report was planned for publication in September 2018 and EMA will be contacting those Sponsors individually. This information was communicated directly by an EMA representative at a web meeting of the DIA's "CTD Community" in mid-September 2018.
  3. EudraCT Clinical Trials Tracker is fully established. This tool is searchable by Sponsor and indicates the percentage of reported trials on EudraCT - out of the trials that are due to report.
  4. In September 2018, 11 national research funding organisation, backed by the EC and the European Research Council (ERC), announced the launch of cOAlitionS, an initiative to make full and immediate Open Access to research publications a reality. By 1 January 2020, the aim is to fulfil this main principle: “By 2020 scientific publications that result from research funded by public grants provided by participating national and European research councils and funding bodies, must be published in compliant Open Access Journals or on compliant Open Access Platforms.”

Journal Publication of Interest

The 2018 BMJ Article: "Compliance with the requirement to report results on the EU Clinical Trials Register: cohort study and web resource" describes compliance of 50% for results posting on EudraCT over a 1-year period to 21 December 2016. This paper also describes the EudraCT Clinical Trials Tracker. 

Resources

A recording of the 27 September 2018 TransCelerate Webinar Session on their Common Protocol Template, along with a PDF slide deck is available from https://connect.eventtia.com/en/dmz/4d19/website