New Clario research reveals equal clinical trial patient compliance at-home and on-siteMay 19, 2022
Study findings confirm decentralized clinical trials (DCTs) are a viable and effective option for oncology studies
- Guidelines from the FDA and EMA require more frequent patient-reported outcomes (PROs) across more categories for investigational oncology compounds
- New research by Clario demonstrates that patients are just as compliant when completing PROs at home as they are on-site
- New research shows that with a full endpoint strategy, DCTs can meet the new regulatory requirements and effectively engage patients
PHILADELPHIA, PA — May 18, 2022 — Clario, a technology company that delivers the leading endpoint solutions for decentralized (DCT), hybrid and site-based clinical trials, announced today, at ISPOR 2022, findings that show oncology clinical trial patients are just as compliant when completing PROs at home as they are when completing PROs on-site. Clario also outlined recommendations for creating a PRO strategy that is better aligned with the Food and Drug Administration (FDA) and European Medicines Agency (EMA) recommendations.
“Our findings demonstrate that at-home PRO completion is a viable method for oncology clinical trials,” said Kelly Dumais, Ph.D., a Senior Scientific Advisor at Clario who conducted the research. “We believe this will help accommodate the recommendations of increased PRO frequency by the FDA. 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. It could mean the difference between them participating, or not – having access to a life-changing therapy or not.”
There is increasing regulatory emphasis from both FDA and EMA on the importance of incorporating the patient’s perspective and experience into the risk/benefit evaluation of investigational oncology treatments. Most recently, the FDA released a 2021 Draft Guidance on Core PROs in Oncology Clinical Trials that emphasizes the collection of five PRO categories and the more frequent collection of PROs (potentially weekly for some for the first few treatment cycles).
In addition to revealing its findings, Clario also outlined recommendations for creating a PRO strategy that may better comply with the FDA and EMA recommendations, both on the types of PROs being collected and the frequency with which they are collected.
For PRO strategies, Clario recommends including disease-specific assessments and/or patient-reported symptomatic adverse events. A shift away from on-site/tablet collection of PROs towards at-home handheld/BYOD PRO collection to accommodate more frequent (and more convenient) PRO collection without adding additional site visit burden is also recommended. Finally, when planning a PRO strategy for investigational products, the incorporation of wearables or precision motion to collect objective information on physical functioning should be a key consideration, as physical function is a key PRO category recommended by the FDA in its new guidance.
To receive additional details and a copy of the poster, contact our science team at [email protected]
Clario is a leading technology company that generates the richest clinical evidence in the industry for our pharmaceutical, biotech and medical device partners. Across decentralized and site-based trials, our deep scientific expertise, global scale and the broadest endpoint technology platform in the industry allows our partners to transform lives. Clario’s Trial Anywhere™ solutions have been powering hybrid and decentralized clinical trials (DCT) for over 15 years, enabling sponsors to collect high-quality endpoint data from any modality or location, all while improving the patient experience and diversity. Clario has the only technology platform that combines eCOA, cardiac safety, medical imaging, precision motion and respiratory endpoints. With 30 facilities in nine countries, Clario’s global team of science, technology and operational experts has helped deliver over 19,000 trials and 870 regulatory for over 5m patients in 120 countries. Our innovation has been transforming clinical trials for 50 years.
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