REGULATORY PUBLIC DISCLOSURE (RPD) - January

ICH and EC Updates

1. ICH continues to advance as it prepares for its 30-year anniversary. This ICH Press Release tells us what is ahead, and reports on some important appointments. Of note is that Health Canada’s Director General – Dr Celia Lourenco – is re-elected for the next 2 years as Vice Chair, ICH. You may recall that Celia was the Health Canada Regulator who provided her team’s input to CORE Reference during its 2-year development (2014 to 2016).

Key Milestones (selected by Sam to be of substantial interest to Medical Writers):

• Adoption of new ICH E9(R1) (Step 4) Addendum to Defining the Appropriate Estimand for a Clinical Trial/Sensitivity Analyses. [Celia advised during the development of CORE Reference that Estimand would emerge as one of the most important considerations in statistical trial design – and we included it]
• New topics in advancement
• E6(R3): Good Clinical Practice – watch out as the GCP update is coming!
• E20: Adaptive Clinical trials
• M12: Drug Interaction Studies
• ICH publication of Nov 2019 survey results to understand the state of ICH Guideline implementation by ICH Regulatory Members and Observers. Survey results point to “strong evidence of adequate implementation and adherence to the Guidelines”
• Next ICH Meeting 23-27 May 2020 in Vancouver, Canada.

1. Version 2.3 of Draft Q&A on Clinical Trial Regulation (EU) no. 536/2014 published November 2019 covers 17 Qs on the scope of the CTR in the EU; 9 Qs on the application process; 11 Qs on the substantial modification process; 3 Qs on application withdrawals; 6 Qs on Sponsor/Legal Representative and Investigator responsibilities; 47 Qs on safety reporting; 4 Qs on IMP manufacturing and import; 4 Qs on Informed Consent; 12 Qs on temporary halt of a study; 13 Qs on the transition period (between the Directive and the Regulation); and several ‘miscellaneous’ Qs.

Key Questions (considered by Sam to be of practical interest to Medical Writers):

‘6. Submission of results of clinical trials’:

• At least primary and secondary endpoints in summary results postings
• At least primary and secondary patient-relevant endpoints in lay summary results
• Sub-study summary results to be posted at the same time as main study summary results
• …and Q11.13: ‘What are the applicable transparency requirements?’:
• Any new document produced as of the moment of the transition of a trial will fully fall under the transparency rules of the Clinical Trials Regulation (the transparency rules applicable to the Portal will apply to them, including deferrals for making certain documents publicly available).
• Clinical trials that were initially started under the Directive and switched to the Regulation have to comply with all the obligations of the Regulation e.g. the publication of summary of results, notifications and, if applicable, the Clinical Study Report (CSR).

As always, with both of these important documents from ICH and the EC – don’t rely on my summary, which is intended to give a few useful pointers – read them for yourselves.

FDA Guidance on Adaptive Design Studies

Released in November 2019, this FDA Guidance ‘Adaptive Design Clinical Trials for Drugs and Biologics Guidance for Industry’ covers ‘…important principles for designing, conducting, and reporting the results from an adaptive clinical trial’.

Certificates of Confidentiality

This is a follow-up to a previous email that I sent you on 03 Dec 19. I asked if anyone could find the FDA Docket link for their November 19 Draft Guidance ‘Certificates of Confidentiality’ . Thank you to Art Gertel, who supplies this link to the Docket. Art also says: “FYI – the NIH already issues CoCs when they issue a research funding grant and, in fact, FDA already has a CoC program”.

NIH Data Management and Sharing Activities Related to Public Access and Open Science – Office of Science Policy

Access this page for links to Draft NIH Policy for Data Management and Sharing and Supplemental Draft Guidance (November 2019). The Policy is new and includes components for ‘Data Management and Sharing’, as well as ‘Elements of Data Management and Sharing Plan’. Comments are now open on this Policy.

International Committee of Medical Journal Editors Updated Guidance

Read the Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly work in Medical Journals, updated December 2019. To assist in identifying where changes have been made, an annotated PDF is available.

Clarity around authorship criteria, required transparency, and avoiding predatory journals is added. Of particular interest is the explicit statement on page 13 that approval to conduct a study by an IEC/IRB does not fulfil the ICMJE requirements for prospective trial registration.