June 25, 2018
Machine-readable instructions could revolutionize the clinical trials process
By: Michel Rider and Stacy Tegan

Earlier this year, we were excited to be part of a DIA 2018 Global Annual Meeting panel, presenting with TransCelerate on the Common Protocol Template and Digital Data Flow initiatives. The Common Protocol Template (CPT) is an effort to provide a model clinical trial protocol template that provides a common structure and language. It’s designed to increase consistency across trial protocols and to enhance the clinical development process. By working with industry stakeholders (investigators, site staff, ethics committees and regulators), the goal is to achieve broad adoption, to enable more complex clinical trial design, improve quality, accelerate the clinical trial process and reduce costs to support a wider variety of companies and innovations in therapeutic products and services.

In organizations where the CPT has not been adopted, the current process is comprised of a clinician writing a protocol as a document in a program such as Microsoft Word. The process then relies on the translation of the ideas in this document, from human to human, and from human to machine, to capture the pieces of data necessary to test the clinician’s hypothesis. It’s a laborious process that’s vulnerable to human interpretation at every stage. Due to the lengthy timeframes involved (4-6 months to get a new study started, 2-3 months to close out a study, 6 weeks to prepare data for an interim decision), it means data affecting patients with high unmet medical need are at best 6-8 weeks old.

Those using the CPT find that the standardized template makes their clinical trial process more nimble, less arduous and significantly faster. Clinicians still create their protocol in a document (in the current version of the template), but the document includes XML fields for machine-readable instructions, a library of commonly used text and content automation. It is vendor- and solution-agnostic, making it accessible to any organization wanting to use it, and it has strong support from regulators (including the FDA and NIH).

Rob Dicicco, TransCelerate Senior Advisor and former CPT Workstream Lead and Operations Committee member explains, “There have been five releases and more than 5000 downloads since the first version was made available to the public in 2015—an amazing achievement in just three years—and usage is increasing rapidly as awareness grows. TransCelerate has committed to an annual release cycle driven by user feedback and collaboration across the biopharmaceutical research and development community.”

With our focus on intelligent data flow and digital trust, Accenture is thrilled to be part of the CPT effort. We believe the use of machine-readable instructions could truly revolutionize a process that’s always been highly paper-based and transactional. These machine-readable instructions, combined with intelligent data flow that can be trusted in terms of veracity and security, mean that stakeholders will have access to real-time data for improved, data-driven insights. By harmonizing the structure, organization and semantics of clinical trials, we also expect to simplify regulatory compliance.

“It’s exciting to see organizations around the world working on similar initiatives. ICH, for example, is actively developing the Clinical electronic Structured Harmonized Protocol (CeSHarP)”, added Rob Dicicco.

We were grateful for the opportunity to share the CPT with the DIA Annual Conference attendees and to hear from organizations about their experiences using the template.

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