European Coalition Issues Recommendations for Improving Clinical Trials
A coalition of European medical societies and patient advocates has published recommendations for making EU trials less burdensome, more efficient and more tailored to patients.
The Coalition for Reducing Bureaucracy in Clinical Trials, which shared its recommendations shortly after the EU’s Clinical Trials Information System (CTIS) and Clinical Trials Regulation (CTR) went into effect last week, is focused on cutting down administrative burdens in four critical areas: safety reporting, informed consent, regulatory guidelines and united implementation of the CTR across member states.
For example, the coalition believes it’s critical that industry streamline adverse event reporting to prevent investigators from having to use multiple systems required by individual sponsors and CROs.
“Ideally, investigators should have to focus only on the medical aspect of adverse events — i.e., those elements directly related to the patient and the disease,” the group said. “For selecting the most appropriate interface, sponsors/CROs should seek input from investigators and advice from statisticians and IT services. To ensure that safety reports are as informative as possible, a proportionate, stratified approach to the collection of adverse events should be adopted.”
In making safety reporting a less demanding, arduous task for investigators and site staff, the EU should endorse a simplified form for safety reporting in order to send a message to sponsors and CROs not to submit unneeded information, the coalition said. This would also instill confidence in investigators to submit less work-intensive reports that include only essential information. The main list of items to be detailed on this simplified form should be hashed out amongst stakeholders and account for both industry and academic sponsors, as they may gather data differently.
The EU should endorse a simplified, electronic form for safety reporting that uses electronic signatures for all submissions of adverse events, the coalition advised.
Trial protocols can also be designed in a way that keeps unneeded, excessive safety reporting to a minimum. To that end, the group recommended that sponsors and investigators list the periodic reviews of aggregated safety data to increase the visibility of safety signals, sorting by organ classes and grading signals by severity with a focus on grades III and IV.
Read the full recommendations here: https://bit.ly/34dxiGX.