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 and reduce 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.
A look at the challenges stakeholders face
Oncology trials frequently involve complex study designs, making it harder to communicate key trial information to participants during the consenting process. Ensuring participants' thorough understanding of complex requirements is crucial for the success of oncology trials, yet difficult to achieve.
Oncology trials may often require multiple consents, including consents for sub-studies and biosamples. Mid-study protocol amendments are also common, requiring participants to re-consent. This increase in forms can cause participant confusion and frustration while generating more work for sites.
As mentioned, oncology trials often result in a high participant burden that can be compounded by lengthy and complex site visits. Participants are often unwell, due to their existing condition and may be experiencing side effects from treatment. This makes travel and certain trial tasks, such as writing diaries, difficult. Oncology side effect measurement typically occurs during site visits and missing fluctuations throughout the treatment cycle can create scenarios where sites potentially lack vital information.
The downstream impacts of participant burden often manifest in the form of missing data, creating challenges when sponsors look to analyze treatment impact and efficacy. Adding to this is the frequent lack of diversity of participants in oncology trials, limiting the generalizability of trial results to real-world populations.
Oncology treatments also exhibit unique toxicity profiles. Side effect measurement typically occurs during site visits, missing fluctuations throughout the treatment cycle and potentially vital information.
Historically, oncology trials have focused on objective clinical endpoints, neglecting the inclusion of PRO measures. However, recent FDA guidance supports PRO measures and emphasizes the need to incorporate the participant voice in drug development.
For sites, oncology can be some of the most burdensome due to complex workflows, multiple treatment cohorts, and the various forms of data capture required within one visit. Dosing delays are also common, further impacting site workflows and timelines.
Finally, historically there has been a lack of standardization in the PRO measures used across trials. Different domains are measured, hindering treatment comparisons and reducing the regulatory utility of their data. With PROs now being supported by the FDA, the industry should work towards some level of standardization for the future, in order to ease certain oncology trials.
Easing these challenges
Digital and decentralized technologies have the potential to revolutionize the landscape of oncology trials, offering solutions that can alleviate many of the challenges faced.
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