Here are two statistics that may surprise you. 

Number one, according to the WIRB-Copernicus Group, the number of oncology trials has skyrocketed over the last decade, almost doubling the number of all other therapeutic areas combined. 

Number two, between 2010 and 2020, only 9 out of 108 FDA-approved oncology drugs, a mere 8.3%, included electronic patient-reported outcomes (ePROs) in their labeling.

Clearly, ePRO adoption is lagging in oncology trials. This comes despite recent guidance from the FDA (in 2021 and 2024) explaining how sponsors can use these technologies to ease trials for themselves and their patients. 

Regulators expect sponsors to capture the patient’s voice

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A top-10 global pharmaceutical company partnered with Medable for their pivotal Phase III diabetes study in the highly competitive market. Recognizing the inefficiencies in traditional study delivery and closeout processes, the company leveraged Medable’s expertise to accelerate timelines, enhance operational efficiency, and achieve a faster time to market for this high-profile therapy.

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Electronic clinical outcome assessments (eCOA) have become essential for modern clinical trials, offering numerous advantages over traditional paper-based methods. However, the benefits of eCOA can only be fully realized if the data collected is of the highest quality. Ensuring data quality in eCOA clinical trials requires a multifaceted approach, encompassing platform design, patient engagement strategies, robust data validation procedures, and strict adherence to regulatory guidelines. This blog post explores key strategies for achieving and maintaining data quality throughout the eCOA process.

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