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ePRO
Enhancing Oncology trials with digital solutions: A focus on patient-reported outcome measures and eConsent
Over the last decade the number of oncology trials has skyrocketed, almost doubling the number of all other therapeutic areas combined, according to the WIRB-Copernicus Group¹. Known for their complex design, oncology trials often present various participant, site, and sponsor hurdles.
Sponsors and CROs looking to tackle these challenges andreduce the burden on participants and sites should explore the potential of digital solutions, particularly electronic informed consent (eConsent) and electronic patient reported outcomes (ePRO). Both tools offer expanded views of the participant journey while offering feedback that enables sponsors and CROs to enhance and refine their trials for all stakeholders.
Back to basics: What are wearables and how are they powering diversity and efficiency
Mobile health technology, like medical-grade wearabledevices, can transform patient monitoring by enabling the collection of newtypes of data and better accuracy of patient responses. This tech can increaseaccessibility of trials for patients and even increase diversity and reducepatient burden by removing geographical and travel barriers.
As a result of these myriad benefits, we’ve seen theincreasing inclusion and acceptance of wearable devices throughout clinicaltrials. Here, we’ll dive into the specifics of these helpful tools and theirimpact on the future of medicine.
Back to basics: What are electronic clinical outcome assessments (COAs/eCOAs)?
COAs (called eCOAs when captured electronically) are essential to understanding whether a drug is reducing symptoms, improving patients’ quality of life, and improving patients’ ability to perform activities they care about. COAs enable a well-rounded understanding of how a drug is working, its side effects, its impact on patients’ lives, and more. Perhaps most notably, PROs/ePROs allow for the patient’s voice to be heard. Capturing the patient’s voice is particularly important because the clinician may not always see or express the patient’s experience in the same way.
Back to Basics: What is a decentralized clinical trial?
In a decentralized clinical trial, part or all of the protocol occurs away from the primary study site. Instead of patients traveling, often repeatedly, to a central site for enrollment, consent, data collection or symptom monitoring, they can participate in telehealth visits from their homes, often using familiar technologies, like smartphones, tablets and wearables to transmit pertinent information. Even medications and devices can increasingly be delivered directly to a patient’s home, and a home visit from a health care professional can be arranged if necessary.
Leverage novel options in oncology clinical trial design to reduce burden for patients and sites
Flo Mowlem, Senior Director, eCOA Science & Solutions shares insights on how electronic solutions, with a focus on patient-reported outcome (ePROs) can reduce burden on participants and sites to maximize the chance of success in oncology clinical trials.
How to design patient-friendly and inclusive ePRO instruments
This blog explores why patient-centric ePRO instrument design is critical to driving study success, provides tips on how to make instruments more patient-centric, and offers resources for additional ePRO design guidance.