At the 2024 SCOPE Summit, Laura Galuchie, Senior Director and TransCelerate Program Lead at Merck provided a fresh perspective on the future of clinical trials. Her session, centered around strategic protocol development, likened the process to crafting a narrative, reminding us that every good story, or in this case, every effective protocol, starts with a fundamental idea.
The Tale of Protocol Development: A Narrative Framework
Galuchie began her presentation with a reminder of the basics: before diving into a decentralized clinical trial (DCT), it’s vital to return to the story “Once Upon a Time.” She invited attendees to reframe their thinking, not as assembling a procedural list but as crafting a story with intent and purpose. The idea isn’t to start with a pre-existing template but to begin with a clear understanding of the objective, the hypothesis, the context within the program, and the patient population — the central characters in this narrative.
From Page to Practice: Contextualizing DCT Components
Using Merck‘s protocols as a blueprint, Galuchie detailed how each element of a DCT—eConsent, home healthcare, telemedicine, remote monitoring, and more—is carefully considered and applied. She provided a poignant example, paralleling overpacking a suitcase and overloading a protocol with unnecessary elements. Just as one wouldn’t pack a winter coat for a trip to the tropics, clinicians shouldn’t integrate DCT elements without assessing their relevance and necessity.
Crafting with Critique: The Essential Items of a Protocol
Merck’s approach to adding procedures into a protocol is thoughtful and methodical, emphasizing the support of endpoints, safety evaluation, and patient population enrollment. Galuchie provided an example of a respiratory trial, where not every conceivable test is performed but specific ones pertinent to the hypothesis. She encouraged critical thinking about every procedure’s necessity and frequency, showcasing a willingness to deviate from historical standards in favor of what is most appropriate and participant-friendly.
The Purposeful Build: Beyond Expediency
Building upon this, Merck’s philosophy of “building with purpose and intention” shines through as Galuchie stressed the importance of only including procedures that directly contribute to regulatory and tool requirements. She cautioned against including procedures for exploratory purposes, advocating instead for those who genuinely advance understanding of the molecule or the disease.
Placing the Procedures: A Thoughtful Balance
Galuchie discussed the fine line between centralization and localization of trial procedures. She emphasized balancing the benefits of local labs for patient convenience with the scientific rigor of centralized assessments. She drew attention to the significance of including sites and patient feedback in protocol development, highlighting how such insights could prevent protocols from becoming unwieldy or overly burdensome.
Merck’s Strategy: Streamlining for Efficacy
Galuchie’s presentation concluded with a vision of streamlined protocols prioritizing critical data and intentionally applying DCT elements. She described Merck’s continuous effort to refine protocols based on real-world feedback and operational performance. The strategic focus is crafting manageable trials for patients and sites and optimizing internal processes for speed and efficiency.
Moe Alsumidaie is Chief Editor of The Clinical Trial Vanguard. Moe holds decades of experience in the clinical trials industry. Moe also serves as Head of Research at CliniBiz and Chief Data Scientist at Annex Clinical Corporation.
