REGULATORY PUBLIC DISCLOSURE (RPD) - July
1. EMA Clinical Data Disclosure Activities and Guidelines Development: Continuing Hold
Resource constraints oblige EMA to keep guideline development and the publication of clinical trial data on continuing hold. An EMA Management Board meeting is planned in October 2019 to review the situation. Resumption of clinical data disclosure activities and guidelines development are NOT EMA priorities for 2019 - as indicated in this document, which shows the priority goals for EMA in the coming year.
2. Update on EU Clinical Trial Regulation (CTR): Clinical Trials Information System (CTIS)
The IT system that will enable the EU's CTR to come into force is the CTIS. On 18 June 2019, EMA announced that they have revised the CTIS project methodology and plan to improve delivery. Member States and stakeholders (including business experts) are now directly engaged in the development of CTIS to ensure that their expectations are taken into account. This means that business expert representatives may continuously review, select and verify CTIS functionalities.
3. ESTIMAND: EMA SAWP Advice Open for Comment
EMA's Scientific Advice Working Party (SAWP) has released a document for public consultation (comments open until 09 October 2019).
Draft qualification opinion of clinically interpretable treatment effect measures based on recurrent event endpoints that allow for efficient statistical analyses is relevant for the development of estimands, bearing in mind that ESTIMANDS are clinically interpretable treatment effect measures.
Development of medicines is becoming increasingly estimand-based, and as we all try to better understand this developing field, I urge you to share this opinion with your statistical colleagues.
4. CBMRT: Free meetings in US and EU on transparency
The Center for Biomedical Research Transparency (CBMRT) aims to increase transparency in biomedical research reporting. This ISMPP Newsletter reports the content presented in a free-to-attend meeting in the EU in May 2019. More of these meetings are planned for the EU and US.
Although the topics of interest relate predominantly to publications transparency, (and less so to clinical data transparency in the clinical trials industry), free meetings like this where there is overlap of these areas are of interest.
5. CORE Reference Team’s Peer Review Publication in Press
Article titled: ‘Critical Review of the TransCelerate Template for Clinical Study Reports (CSRs) and Publication of Version 2 of the CORE Reference (Clarity and Openness in Reporting: E3-based) Terminology Table’ by the Budapest Working Group (authors of CORE Reference) is in press with the BioMed Central journal, Research Integrity and Peer Review.
When our paper is published (expected imminently), we will publicise the link/DOI and would ask for your support in sharing this widely around your professional networks. Thank you.