Will changes in international standards affect  clinical trials in Russia?

7 March 2017

Will changes in international standards affect clinical trials in Russia?

By June 2017 all ICH members are required to implement new version of ICH E6 GCP. The gold standard for clinical trials was updated in November 2016 - for the first time in 20 years.

The decision to update Good Clinical Practice was made given that scale, costs and complexity of clinical trials have greatly increased in recent decades. The new ICH GCP version takes into account technological and managerial innovations and suggests new solutions in design, methodology, monitoring and reporting in clinical trials. ICH E6 GCP (R2) was developed based on the analysis of regulatory inspections results and is aimed to refine each stage of a clinical trial.

Update of Russian national standard in clinical trials, which in fact is a translation of ICH GCP, has not been announced yet. However, the amount of international clinical trials held in Russia allows to conclude that implementation of updated ICH GCP version will affect clinical trials in Russia. According to Synergy Research Group, in 2016 36% of trials held in Russia accounted for multisite international clinical trials. 58% of approvals for clinical trials issued by Ministry of Healthcare was granted to international sponsors.

Experts are currently analyzing changes in ICH GCP in order to define their potential influence on clinical trials. However, some of the updates are already clear, therefore it is possible to determine the ways of implementing them.

For example, new ICH GCP version clarified the aspect of clinical data control – now sponsor does not have a right to control it exclusively, but has to provide investigators with access to the CRF (ñase report form) data after the trial closure, as well as during the active phase.

One of the solutions to fulfil this requirement is using electronic data capture system. “Such systems provide easy access to data during the trial and allow to grant read-only online access after the end of the trial and database lock.” Irina Vilenkova, Senior Data Manager, comments. “This functionality is implemented in EDC system used by our company.”

Another important innovation in ICH GCP is the notion of certified copy which guarantees quality, authenticity and integrity of data provided to investigators after the end of the trial. “Certified copy is the exact copy of original record and contains the same information, has identical structure, is verified, i.e. is dated and signed or obtained through validated process,” Senior Data Manager DM365 Irina Vilenkova explains. “Certified copies creation can be significantly facilitated with the help of EDC systems. Good system allows sponsors to support their own procedures for validation, data export and data archival in the most convenient format – electronic or paper.”

Definitely a lot of questions raised by ICH E6 GCP update are still to be settled, but a part of them is already covered by service companies’ solutions. Utilization of which can really facilitate upgrade to new clinical trials standards.

Source: Clinical Trials in Russia by Synergy Research Group