San Diego, CA
21-24 October 2018
The MAGI session held in San Diego proved fun and educational. There was a large population of site personnel with a supporting number of professionals from Medical Device and Pharma firms and CROs. We are all waiting to see when or if the US FDA will adopt any of the new informed consent requirements from the Common Rule, which will become effective 21 Jan 2019. The use of technologies in clinical trials was discussed in several sessions with IRB representatives noting the US FDAs support of the eICF technology. All were interested in eICF, noting the device (e.g., tablet, phone, wearable, laptop) must appropriate for the population being studied as many horror stories were shared of failed uses (e.g., tablets for Parkinson’s patients).
The “Compliance Nightmare” session shared experiences related to firms under consent decrees and some of the actions that got them there. The attendees were stunned into silence with the depth of non-compliance by all Stakeholders with agreement that lack of qualification of suppliers (e.g., CROs and sites) and shared communication of expectations was a significant root cause.