A study looking into RWD from 50 post-approval confirmatory studies requested by FDA shows that data is inconclusive and difficult to analyse. The authors mentioned that some of the main challenges are that data from electronic medical records (EMR) cannot be extracted and also it is not clear what kind of interventions are used for different indications. The authors conclude that real word data is unlikely to be able to replace post-approval confirmatory trials.
European Medicines Agency (EMA) has released guide on the new system which will replace EudraCT – Clinical Trial Information System (CTIS). The new system will be used for safety reporting and trial management, and other notifications.
The Combined Review Service (CRC) will replace the old IRAS used for clinical trials submissions in the UK as of 1 Jan 2022. It will be a portal that will allow parallel submission to all regulatory institutions involved in the approval of the clinical trial in UK.
However, the portal is not integrated with some of the specialized committees like ARSAC, GMO committees, etc. This means that separate applications will be required for these committees. Something that needs to be taken into consideration during the submission.
Latest update on the GMO guidance in the European Union includes more information on human cells genetically modified without viral vector and genome edited cells. According to the update if viral vectors are not used the risk to the environment is considered negligent.
European Commission releases guideline on lay summaries for clinical trial protocols. The new document encourages more patient involvement in clinical trials design and stress on the need of paediatric plan.