Always the masters of droll understatement, the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) issued a directive today (March 12) noting it was “aware that there are challenges arising in relation to Coronavirus and the effect this is having on the conduct of clinical trials.” Broadly speaking, the virus thus far has impacted Europe—especially Italy—more forcefully than in most of the United States, though the situation is seemingly changing moment by moment.
MHRA acknowledges current coronavirus-related conditions will “increase…protocol deviations; please ensure they are well documented, to enable appropriate evaluation for the trial.” MHRA adds, “an increase in protocol deviations in relation to Coronavirus will not constitute a serious breach, therefore there is no need to report this to us (unless of course patients are being put at risk).”
Special situations may require special actions, MHRA notes. “Resources may need to be assessed in hospital settings, with staff working primarily in research being required to assist in other areas,” it advises.
For example, certain oversight duties, such as monitoring and quality assurance activities might need to be reassessed and alternative proportionate mechanisms of oversight introduced (such as phone calls, video calls, etc.) to ensure ongoing subject safety and well-being, the agency says. “We would advise a brief risk assessment and documentation of the impact of this, with consideration of prioritization of critical activities such as safety reporting,” it adds.
MHRA echoes recent renewed interest in new ways of conducting trials that require less direct physical contact. “Remote monitoring can be considered; however, this should not place an extra burden on trial sites, and subjects must consent to any sharing of their personal information outside the trial site,” MHRA suggested.
Another tip from MHRA: “If your processes require wet-ink signatures, consider alternative methods of demonstrating approvals, such as email confirmation. Inspectors will take a pragmatic approach to this, but you may want to consider [a standard operating procedure] deviation to cover this in the interim.”
Author: Michael Causey