Sponsors should flag decentralized aspects of cancer trials to prep for the post-Covid era, FDA says
As more and more clinical trials during the pandemic have harnessed the power of remote assessments and modifications, the FDA Oncology Center of Excellence and the Office of Oncologic Diseases are now requesting that applicants voluntarily add flags to datasets to discriminate between remote assessments and trial site assessments.
The push from the FDA to flag these differences is part of an effort to ameliorate the fact that there is currently no standard way to identify Covid-related modifications in clinical trial datasets submitted to the FDA. And many of these remote modifications were deployed in the middle of large ongoing cancer trials as a way to minimize Covid risks, the agency said.
An Oracle survey from last November found that 76% of biopharma companies and CROs surveyed said the pandemic sped their adoption of decentralized trials. But industry respondents were also divided on whether there has been enough regulatory guidance around this push toward decentralized trials.
“FDA hopes to learn more about the opportunities and challenges of these REMOTE modifications to foster use of ‘decentralized’ aspects of clinical trials prospectively in the post-COVID era,” the agency said.
Still, the use of full or hybrid decentralized designs by trial sponsors has been rare in oncology, the agency notes, partly because of the uncertainty surrounding the effect of remote assessments on data quality and outcomes.
But the FDA insists that better understanding these modifications can reduce uncertainty for sponsors and regulators, and identify mitigation strategies for future, prospective decentralized designs.
More specifically, the agency is calling for companies to flag any instances of remotely conducted clinic visits, lab or imaging assessments, or delivery of investigational products.
“While trial datasets may already be identifying REMOTE modifications as protocol deviations, we would like all REMOTE assessments to be flagged, rather than only those assessments that result in protocol deviations, given that once a trial protocol is amended to allow remote assessments they will no longer be considered Protocol Deviations,” the agency added.
In terms of potential research questions to explore further, the agency points to studying the effects of remote lab and imaging assessments, as well as remote investigational product administration to compare dose modification rates, adverse event rates, image scan quality, and the effect of replacing in-person follow-up meetings with telemedicine.