People taking part in cancer drug trials at home comply with treatment protocols almost as much as people involved in site-based research do, according to analysis by Clario Research.
The study—which is based on the analysis of data from 14,284 participants from 25 oncology trials—found the compliance rate for at-home trials in which patients reported using a hand-held device was 83.9% compared with 86.3% in site-based research. The findings, which were presented at ISPOR in Washington, D.C., this week, indicate that decentralized studies are a good option for cancer drug developers, according to lead author Kelly Dumais, who is senior scientific adviser at Clario.
“Our findings demonstrate that at-home [patient reported outcomes] completion is a viable method for oncology clinical trials. It’s comforting to know that DCT technologies can, in fact, enable oncology patients who are not feeling well to meet increasing study requirements from the comfort of their homes,” Dumais said. “It could mean the difference between them participating, or not—having access to a life-changing therapy or not.”
The results also suggested at-home studies in which people use hand-held devices to report could help drug developers and CROs comply with guidelines on patient-reported outcomes (PROs) issued by the FDA last year.
“With new regulatory guidance on PROs in oncology comes the responsibility of those designing and conducting trials to not only collect what is meaningful to patients, but to do so in a way that minimizes patient burden,” the study said. “Our results show that PRO compliance remains high when collected at home on a handheld device, and is comparable to on-site compliance, providing evidence that at-home electronic PRO completion is a viable and important strategy for PRO collection in oncology clinical trials.”
In the research, Clario also provides tips for effective PRO strategies—for example, that trial sponsors and CROs include contingencies for disease-specific assessments and patient reporting of symptomatic adverse events.
In addition, the authors recommended developers incorporate wearables that can collect objective information on physical functioning, explaining that “physical function is a key PRO category recommended by the FDA.”