Article | August 7, 2023

Focusing On Patient-Reported Outcome Measures And eConsent

Source: Medable
GettyImages-1385471311 patient tablet

Over the past decade, there has been an exponential increase in the number of oncology trials, nearly doubling the combined number of studies in all other medical fields, as reported by the WIRB-Copernicus Group¹. Renowned for their intricate design, oncology trials often come with a range of challenges related to participants, trial sites, and sponsors, impeding their smooth progress.

As the number of oncology studies increased, historically, the trials primarily concentrated on measurable clinical outcomes, often overlooking the integration of PRO measures. Recently, however, the FDA has started to advocate for the utilization of PRO measures and underscored the importance of including participant perspectives in the process of drug development.

To meet FDA guidance and address the aforementioned hurdles while alleviating the burden on participants and sites, sponsors, and CROs should consider exploring the potential of digital solutions. Among these, electronic informed consent (eConsent) and electronic patient-reported outcomes (ePRO) stand out. These tools not only provide a broader perspective of the participant journey but also offer valuable feedback that empowers sponsors and CROs to optimize and fine-tune their trials to benefit all stakeholders involved.

Access the full article below to learn how a shift to digital solutions would contribute to a more participant-centered approach and how the efforts could enhance the regulatory utility of PRO data while improving the overall quality and efficiency of oncology trials.

access the Article!

Get unlimited access to:

Trend and Thought Leadership Articles
Case Studies & White Papers
Extensive Product Database
Members-Only Premium Content
Welcome Back! Please Log In to Continue. X

Enter your credentials below to log in. Not yet a member of Clinical Leader? Subscribe today.

Subscribe to Clinical Leader X

Please enter your email address and create a password to access the full content, Or log in to your account to continue.


Subscribe to Clinical Leader