In last October’s Applied Clinical Trials Online magazine, I wrote an article to provide context about digital Protocols. The article explores the concept of digital clinical trial protocols, which aim to streamline the processes of designing, managing, and implementing clinical trials.
Traditionally, clinical trial protocols have been documented in Word or PDF formats, following the structure provided by the TransCelerate Common Protocol Template. While this standardization has improved consistency, it still requires manual work, such as copying information into downstream documents and specifications for data collection systems.
A digital protocol will offer a more automated and efficient approach. TransCelerate’s eTemplate Suite (eTS) introduced limited automation by reusing a number of protocol elements in other study documents. The next evolution involves leveraging fully digital protocols that could directly feed information into downstream systems without manual intervention. TransCelerate’s Digital Data Flow initiative, in partnership with CDISC, is developing the Unified Study Definition Model (USDM) to standardize digital protocol information. This will align with the upcoming ICH M11 guidelines and set the stage to connect with HL7-FHIR standards to help connect clinical research with clinical care.
The article categorizes digital protocol tools into three key functions: content reuse, workflow automation, and analytics-driven study design optimization. Content reuse allows narrative components like objectives and eligibility criteria to be applied across multiple studies. Workflow automation involves digitizing structured protocol elements, such as an electronic schedule of assessments (eSOA), to automate configuration of clinical systems. Analytics-driven tools provide real-time data insights to help clinical scientists and other experts optimize study design, including patient recruitment and study costs.
While fully digital protocols that serve as the “source of truth” are not yet widely implemented, progress is being made. The article advises sponsors and contract research organizations to define their objectives—whether content reuse, automation, or analytics—before selecting digital protocol tools.
futurpositif 