EU Clinical Trial Registry: small industry and academia lack of compliance in reporting Clinical Trial Applications results

Massimo ZaninelliNo CommentsClinical Trials Transparency, news

During the webinar “Tackling the EU CTR Compliance Challenge”, (September 12th, 2018), Thomas Wicks, Chief Strategy Officer of TrialScope, shared staggering statistics on EU CTR compliance (or the lack thereof). While the top 50 industries are doing pretty well (more than 90% of results posted), small enterprises and academia are doing relatively poorly in term of results that are missing (65% and 75% respectively).

The information is confirmed by EU Trials Tracker, a live website tool that monitors, on a monthly basis, every trial that breaches EU rules on trial reporting. According to its later report, as of January 2018, only 49% of the EU CTR clinical trials reported results in the register. (Source:Evidence- based Medicine Data Lab, University of Oxford).

So far, public data on EU CTR come from 32,764 studies, half from industry and half non-industry, while only 10,419 are reporting results, with the vast majority of these results coming from industry studies.

Coming to “What’s next” Wicks expects that soon a scientific article, similar to Research sponsors who fail to report results to be named and shamed, (BMJ, February 22, 2018), will be published on research sponsors who fail to report results. He predicts that someone from a non-compliant organisation might receive a call from her or his Chief Medical Officers to put in place a plan to resolve the non-publication issue(s).

To avoid these undesired call and remediate non-compliance gaps, Wicks suggests to prioritise the results disclosure:

–    documenting acquisitions since May 2004,

–    listing all organisation’s EU studies,

–    assessing results disclosure due dates,

–    collecting available information (e.g. CSR Synopsis, CT.gov results), and

  • prioritising the disclosure, a sponsor has to do. In this scope, he recommended starting from the upcoming studies in the next 12 months, passing then to the ones past due by 12 months or less, finishing with the ones past due by more than 12 months.

Wicks warmly suggested to establish a global disclosure function; to update the organisational SOPs and Guidelines; to document non-compliant studies ASAP; to develop a remediation plan & communicate it to company executives; to engage services to address the backlog; to implement technology to streamline disclosure and avoid future issues.