July 2019

1 - EU CTR 536/2014 June 2019 Q&A

EU guidance documents applying to clinical trials are described in the Clinical Trials Regulation (EU No. 536/2014). A draft Q & A document dated June 2019 has been released and submitted for discussion to the Expert Group on Clinical Trials. Some sections of the Q&A are incomplete and we can therefore expect this document to be updated. There is a lot of information in the Q&A, as we might expect - do note Section 6 'Submission of Clinical Trial Results'.

2 - EMA/HMA Issue Letter to Stakeholders on Clinical Trial Results Reporting

Reporting of clinical trials results in EudraCT is the direct responsibility of Sponsors. The EMA and HMA have issued a joint letter to remind Sponsors of their responsibilities. They particularly mention underreporting by non-commercial Sponsors, and provide links to resources that all Stakeholders may find useful in meeting their reporting obligations. This 03 July 2019 joint letter is mentioned directly on the EMA's Clinical Trials in Human Medicines page.

3 - FDA Pilot CDS Program + Integrated Review Template: Open for Feedback

On 26 June 2019, FDA concluded the recruitment phase of its clinical data summary pilot program in which one Sponsor company voluntarily participated. FDA has published a Federal Register Notice seeking feedback on the pilot. The comment period ends on 26 August 2019. FDA hopes to learn from its stakeholders more about the potential benefits or risks, resource requirements, and challenges of FDA publicly releasing a limited number of sections from certain CSRs at the time of marketing approval. FDA have also released a new integrated template that will be used to document FDA's review of new drug applications and efficacy supplements. The federal register notice seeks public comment on both of these efforts. This important development is of interest to our professional community because this opens a potentially new and alternative pathway for public disclosure of clinical documents to that of the publication of CSRs and clinical summary documents that we have to date seen from the EMA and Health Canada. Note that the FDA's open comment period falls within the traditional summer holiday period, so if we as stakeholders are to have our say, we really must not delay our efforts. Remember the Docket closes on 26 August 2019. Sam Hamilton and Art Gertel submitted comments to this FDA Docket on 15 July 2019 electronically although comments are not showing on the Docket yet (18 July). These are also posted on the CORE Reference website here, and are accessible through the News Summaries page: https://www.core-reference.org/news-summaries/

4 - BMJ paper on data sharing across Pharma companies

In their May 2019 BMJ paper titled "Sharing of clinical trial data and results reporting practices among large pharmaceutical companies: cross sectional descriptive study and pilot of a tool to improve company practices", Miller et al show that "...Despite noteworthy commitments by some companies to share participant level trial data and a willingness by others to improve their policies, many companies still have substantial room for improvement." We hear much about our academic counterparts being 'behind the curve' in terms of clinical trial data sharing; this paper shows that the Pharma industry also has some way to go.

5 - BMC paper on medical writing and CSRs

This paper by Evuarherhe et al titled: ‘Professional medical writing support and the quality, ethics and timeliness of clinical trial reporting: a systematic review’ published 10 July 2019 describes the relationship between professional medical writing support for authoring CSRs, and the quality, ethics and timeliness of publications reporting clinical trials.

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