7 Key Insights: Driving toward better patient outcomes in drug development
How clinical teams are leveraging digital biomarkers in clinical trials to measure what matters and improve quality of life for patients.
ICON and HumanFirst recently attended the Regeneron-hosted Digital Biomarker Summit, an illuminating and important event for anyone involved in the development of clinical trials. For those unable to attend, we’re sharing some key takeaways from the summit that highlight the evolving landscape of digital biomarkers and their impact on clinical research.
- Defining purpose to guide evidence strategy
A core message from the summit was the necessity of aligning a trial’s purpose with its evidence strategy. Depending on the hypothesis being tested, evidence requirements can vary significantly. A comprehensive evidence strategy must incorporate diverse assessment types, including but not limited to Digital Health Technologies (DHTs) and Clinical Outcome Assessments (COAs). This alignment ensures that regulatory requirements are met and the trial’s objectives are clearly supported by the data gathered.
2. Demonstrating the value of digital biomarkers through case studies
Though digital measures are becoming of increasing interest to clinical teams as the effectiveness of digital is continually proven, there is still bias in favor of traditional methods, and digital is often relegated to smaller silos of organizations — whether it be through centralized digital teams or within select Therapeutic Areas. To help illuminate the value and importance of digital methods across the enterprise, comparative case studies that offer a side-by-side evaluation of traditional versus digital methods can help dismantle myths and biases to support incorporating digital measures and DHTs in protocols throughout the clinical development process, as early as Phase 1.
3. Collaboration and standardizing methodologies
There is a growing interest in collaboration among sponsors to share standardized approaches to patient measures — clinical teams are not necessarily competing on the selected endpoint, but rather speed to market for the drug itself, so we should continue to share these tactics and build a body of evidence to continue to validate these approaches across the industry. By leveraging similar vendors, we can enhance the reliability of these approaches and have more proof points and knowledge of operational considerations to de-risk deployment. However, it’s crucial to balance the reuse of shared methodologies with the specific needs of individual trials and patient populations. Standard approaches, while beneficial, can sometimes prove ineffective if not adapted to the nuances of each study.
4. Focusing on clinically meaningful measures
An increased focus on measuring what is clinically meaningful to patients is continuing to be a recurring theme. While there is sometimes a concern that repeated assessments in protocols may lead to improvement in the patient due to task familiarity rather than the efficacy of the drug, by focusing on measures that matter to patient outcomes and quality of life, we can ensure that the measurements collected are meaningful and not so easily influenced. Researchers are aiming to develop drugs that modify diseases rather than just alleviating symptoms, emphasizing improved lived experience with the disease.
5. Early integration of clinical meaningfulness
The summit highlighted the importance of embedding clinical meaningfulness into the trial strategy from the earliest phases, not waiting for large scale patient populations in Phase 3. This approach ensures that measures of clinical meaningfulness are integrated into the asset strategy from Phase 1 through to submission. For instance, leveraging intelligence from tools like the Atlas Network, which provides insights on more than 18,000 biomarkers and behavioral measures from 3,600+ AI-enabled wearable sensors, clinical teams can validate the utility and relevance of their strategies throughout the trial lifecycle.
6. Prioritizing patient-relatable outcomes
Research teams are shifting their focus towards outcomes that patients can relate to, such as improvements in their quality of life, rather than purely statistical significance. This patient-centric approach prioritizes tangible benefits over marginal changes that might not significantly impact the patient’s lived experience.
7. Evolving terminology: emphasizing ‘outcomes’
This one was big! The language we use continues to evolve, and there was a notable shift in the terminology used at the summit and within clinical trials. The focus is increasingly on ‘outcomes’ rather than the methods used to achieve them — we’re moving away from specifying the assessment, like digital, and rather referencing the outcome (or precision) measures and patient science. This language shift is particularly important when communicating with regulators, emphasizing patient outcomes and the improvement to quality of life, rather than individual measurements or tools deployed.
Conclusion
The Digital Biomarker Summit underscored a significant evolution in clinical trials, with a stronger emphasis on patient outcomes, early integration of meaningful measures, and collaborative efforts to standardize methodologies. These insights are crucial for anyone involved in clinical research, as they reflect a broader shift towards more patient-centric, evidence-based, and efficient drug development that drives towards noticeable and improved quality of life.
