Clario finds patients are as compliant at home as on-site

Kelly Dumais, PhD – Senior Scientific Advisor 

Our research shows that oncology clinical trial patients are just as compliant when completing patient-reported outcomes (PROs) at home as they are when completing PROs on-site. These findings demonstrate that at-home PRO completion is a viable method for oncology clinical trials, which we believe will help accommodate the recommendations of increased PRO frequency by regulatory agencies.  

Both the Food and Drug Administration (FDA) and European Medicines Agency (EMA) recently emphasized the importance of more frequent PROs across more categories for investigational oncology compounds. They are calling for greater incorporation of the patient perspective and experience surrounding 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 Most recently, the FDA released a 2021 Draft Guidance on Core PROs in Oncology Clinical Trials that emphasizes the collection of five PRO categories and more frequent collection of PROs, in some cases recommending weekly collection during the first few treatment cycles. 

With a full endpoint strategy, DCTs can meet the new regulatory requirements and effectively engage patients. DCT technologies can enable oncology patients who are not feeling well to meet increasing study requirements from the comfort of their homes, which could mean the difference between them participating or not having access to a life-changing therapy or not. 

Our Recommendations 

Following our research, we 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. Key recommendations include: 

• 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.  
• 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]