At-Home Versus in-Clinic Patient Reported Outcome Compliance in Oncology Clinical Trials


Dumais K1, McDowell B2
1Clario, Medford, MA, USA, 2Clario, Geneva, Switzerland

Objectives: There is increased regulatory emphasis on using patient reported outcomes (PROs) in oncology to provide additional information on clinical benefit beyond traditional survival and tumor response endpoints. Latest recommendations highlight core PROs to consider and the need for more frequent assessments for more accurate quality of life evaluation. To accommodate these recommendations, PRO collection is shifting from the clinic to patients’ homes to allow for more frequent data collection while reducing the burden of travel and site visit time. However, given disease progression characteristics, oncology studies are already at risk for low compliance, and unsupervised at-home PRO collection puts greater responsibility on patients. We aimed to determine the impact of at-home data collection on PRO compliance in oncology studies.

Methods: Using data from 25 oncology clinical trials across several indications, we compared compliance between studies collecting PROs via a handheld (with most or all assessments completed at home; N=17 studies) versus a tablet (with all assessments completed at site; N=8 studies). Analysis included 849,091 administered assessments across 14,284 participants.

Results: Completion compliance did not differ between studies collecting PROs via handhelds at home (M=83.9%, SD=6.6%) versus studies using tablets at site (M=86.3%, SD=7.3%; t(23)=-0.79, p=0.44).

Conclusions: 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. Considering new recommendations for more frequent PRO administration, at-home data collection strategies may reduce patient burden by reducing patient travel and visit time. 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.

Conference/Value in Health Info

2022-05, ISPOR 2022, Washington, DC, USA

Value in Health, Volume 25, Issue 6, S1 (June 2022)




Clinical Outcomes, Medical Technologies, Patient-Centered Research

Topic Subcategory

Adherence, Persistence, & Compliance, Clinical Outcomes Assessment, Digital Health, Patient-reported Outcomes & Quality of Life Outcomes


No Additional Disease & Conditions/Specialized Treatment Areas

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