The Near Future of Clinical Study Protocol Design

A digital protocol builder has been on my mind for a while. Several years ago, I consulted with a life sciences organization focused on early development, helping them redesign their end-to-end business process to increase efficiency and productivity from requirements gathering all the way to reporting. As many similar organizations in life sciences, my client relied on a host of disparate systems and spreadsheets, there was no single source of truth, study schedules were developed tentatively based on incomplete protocols because study requirements were missing, and then had to be reworked once full information became available. And avoidable protocol amendments were commonplace. Sounds familiar??

While details may vary, it appears that both in early and in clinical development, the industry continues to operate with a fragmented ecosystem of digital solutions that do not integrate easily with one another, and the lack of a seamless digital data flow is a source of inefficiencies and delays stemming from manual processes. One significant contributor to this state of affairs is a document-driven study design process.

A recent article in the DIA Global Forum pointed to potential savings in the order of millions of dollars if protocol design were to be digitized and enhanced by AI. And in an earlier blog post, I also pointed to protocol design as one of the drivers of avoidable costs in clinical trials.?

Today clinical studies are designed in the process of compiling the protocol document manually. Several people work on building the protocol by passing document versions and the associated edits back and forth, and spending hours sifting through past protocols, scientific literature, and regulatory guidelines to inform the new study design. This approach comes with several limitations such as:

• Inconsistencies and lack of standardization
• Increased risk of errors
• Lack of guardrails and controls that could prevent future protocol amendments
• Maintenance of multiple versions of the document
• Constrained collaboration and communication
• Challenges to ensure regulatory compliance
• Manual downstream processes based on the protocol document

It can take nearly a year to complete a protocol design!

This short video from TransCelerate nicely summarizes the challenges of the document-driven approach to protocol design and the promise that comes with its digitization. TransCelerate’s Digital Data Flow initiative has developed solutions – including the unified study definition model (USDM), a reference implementation for a study definition repository (SDR), and resources for change management support – to facilitate protocol digitization. I believe this is only the beginning.

Establishing a common definition model for the study design is a critical and indispensable step to enable interoperability with downstream systems. With such a model in place, a true disruption to how study design is undertaken will come from a digital protocol builder. Join me on a short imaginary tour of the future of digital protocol design:

• A digital tool where collaborators across functions – medical, toxicology, regulatory, statistics, ethics, and other – can work in a sequence of orchestrated handoffs or asynchronously to design a study protocol,
• Guided and gated workflows with business rules that take protocol creators through the design process step by step, and help prevent errors and omissions,
• A smart tool that can populate protocol fields based on built-in logic and information entered in earlier steps of the workflow, that enforces standardized data formats, and enables value selection for standard fields,
• Automated version control with an auditable change log and tracking,
• A virtual, generative AI-powered assistant that can analyze past protocols, relevant scientific literature, and regulatory guidelines to suggest the narrative for selected sections of the protocol; and that makes recommendations to the study design to prevent avoidable protocol amendments in the future,
• A tools with an approval workflow that outputs a compliant document and supports an electronic regulatory submission,
• A digital protocol builder that seamlessly integrates with downstream systems to pass data to them and enable a level of automation in steps such as the creation of the electronic case report form (eCRF), scheduling, reporting, and more.

While our short tour is imaginary, a digital protocol builder is within reach. Organizations are already experimenting with the application of generative AI for protocol authoring and generation. And platforms such as Salesforce Life Sciences Cloud support functionality needed for guided workflows, intelligent automation, AI-powered assistants, as well as integrations with downstream systems. At Globant we have been exploring options and reimagining the study design process to enable a digital flow of data across systems. Reach out to share your thoughts.