Focusing On Patient-Reported Outcome Measures And eConsent

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.