REGULATORY PUBLIC DISCLOSURE (RPD) - September
Lancet Oncology - Editorial on clinical trial registry reporting
This June 2019 Lancet Oncology Editorial highlights the shortfall in trial registry results reporting by universities in Europe - which we are well familiar with by now. The message is delivered that university triallists should take the lead and make the necessary uploads. This is a direct appeal to those involved using a direct message. The simple and elegant suggestion of the clinical trial registries sending out automated emails as reminders is made.
EMA Call for Sponsors to Publish Clinical Trial Results
Guido Rasi, Executive Director of EMA, and Thomas Senderovitz, Chair of the HMA Management group have recently co-signed an initiative letter to stakeholders to “spread the word about the importance of making clinical trial results publicly available”. "Transparency and public access to clinical trial results, whether positive or negative, are fundamental for the protection and promotion of public health. [This] assures trial subjects that their voluntary participation in clinical trials is useful and that the results have been collated and reported for the benefit of all”. Read more in EMA’s Press Release.
Re-identification Risk from Datasets
Rocher L et al. Estimating the success of re-identifications in incomplete datasets using generative models. Nature Communications, 2019; 10 (1) shows that allowing data to be used, to train artificial intelligence algorithms, for example, is risk laden. This new research shows that once bought, the data can often be reverse engineered using machine learning to re-identify individuals, despite the anonymisation techniques used.
Lebanese Clinical trial Registry
On 25 July 2019, the Lebanese Clinical Trials Registry (LBCTR) became a member of the Primary Registry Network of ICTRP. LBCTR is also becoming a data provider and trials registered with LBCTR will be added to the ICTRP database. LBCTR was established by the Lebanese Ministry of Public Health with the support of the WHO Lebanon office and the WHO Eastern Mediteranean Regional Office (EMRO) IT team. This new registry will contribute to research transparency in the EMRO region and will ensure the registration of all clinical trials conducted in Lebanon.
Cybersecurity in Healthcare
This LinkedIn article on cybersecurity in healthcare is a good reminder of why the protections that we confer on clinical trial participant data through responsible clinical trial sharing are so important.
EMA Tutorials on Posting Clinical Trial Results on EUDRACT
In August 2019, on the EUDRACT public home page, we can see that EMA have opened a new web page for tutorials on posting clinical trial results on EUDRACT. There are tutorials for each step, including registration, inserting each category of results information, validating, and actually posting the results. This is undoubtedly an invaluable resource to support results posting activities.