“No one knows their level of pain and how they feel or function better than the patient. Capturing the patient’s response to an electronic Patient Reported Outcome (ePRO) is always the best option.”
Since its inception, Medable has prioritized scientific integrity and rigor around various aspects of clinical trials. As part of its science team, Cindy Howry, VP of eCOA Science, plays a crucial role in ensuring that Medable’s clinical trial platform accurately captures electronic Clinical Outcome Assessments (eCOAs). Hired in 2023, Howry’s chief purpose at Medable is to ensure that the health economics and outcomes research (HEOR) science behind our technology is based on best practices and regulatory guidance.
With over 24 years of experience in life sciences and computer technology, Cindy has been instrumental in the evolution of eCOAs and digital healthcare tools (DHTs) As a member of the Critical Path Institute’s eCOA Consortium since its inception, Howry has been helping pharmaceutical and biotechnology companies including clinical research organization (CRO) and healthcare better understand how we implement eCOAs and DHTs.
At Medable, the science behind our technology is just as crucial as the design of protocols and dosing regimens. One aspect is ensuring that our clinical outcome assessments (COAs) are “fit for purpose.” GDPR, FDA, and other legal and regulatory frameworks set critical standards around evidence-based data collection. Every assertion about a drug must be meticulously substantiated through rigorous research and the proper investigative tools. Navigating this landscape requires asking precise questions and employing appropriate instruments to ensure compliance and a commitment to scientific integrity and public safety. This is where Howry spends a significant chunk of her time at Medable.
“When selecting COAs, we must consider whether they align with the specific condition, symptoms, and endpoints being evaluated. For instance, an asthma questionnaire would not be appropriate for an oncology study - the two have vastly different health contexts and objectives.”
This means asking the right questions, using the appropriate instruments, and thoroughly vetting the primary endpoints. It’s about interpreting the guidance and regulations, rather than passively following them. Claims about drugs and devices must be verified through rigorous data collection, not assumptions. Building a product to true industry standards requires truly understanding the science behind effective clinical assessments. In an ever-evolving landscape, Medable’s ability to critically examine the evidence and update our technology, processes, and best practices accordingly is essential. Thankfully, this is where Howry’s extensive experience comes into play.
For over a decade, her research has been pushing forward the ways in which we measure study endpoint. Below is a sampling of some of her past research:
- Best Practice Recommendations for Electronic Clinical Outcome Assessment Data Changes
- Selection of and Evidentiary Considerations for Wearable Devices and Their Measurements for Use in Regulatory Decision Making: Recommendations from the ePRO Consortium
- Measurement Comparability of Electronic and Paper Administered Visual Analog Scales: A Review of Published Studies
- Optimizing Electronic Capture of Clinical Outcome Assessment Data in Clinical Trials: The Case of Patient-Reported Endpoints
- “Bring Your Own Device” (BYOD): The Future of Field-Based Patient-Reported Outcome Data Collection in Clinical Trials?
- Best Practices for Avoiding Paper Backup When Implementing Electronic Approaches to Patient-Reported Outcome Data Collection in Clinical Trials
- Implementing New Clinical Outcome Assessment Instruments on Alternative Data Collection Modes: The Electronic Implementation Assessment and Migration Process
Take, for instance, Howry’s pioneering stance on bringing your own device (BYOD). In the early 2000s, the eCOA Consortium took a strict stance that assessments could only be done using a single, standardized device. The device size, brand, and appearance had to be identical across all participants to avoid any potential bias introduced by device differences.
However, as technology advanced, the landscape shifted. The rise of BYOD meant pharmaceutical companies could consider the patients’ using their personal smartphones and tablets for eCOA collection. Through qualitative and quantitative research, they found that the specific device details did not impact the measured health outcomes.
Armed with this evidence, the eCOA Consortium approached regulators and made the case for allowing BYOD. They demonstrated that device variability would not compromise the scientific integrity of the assessments, paving the way for a more flexible, technology-agnostic approach.
The lesson is that even long-standing guidance and best practices must evolve to keep pace with technological change. By staying open-minded, conducting thorough research, and working collaboratively with stakeholders, organizations can adapt their standards to maintain scientific rigor while embracing new possibilities.
As we enter 2025, Howry and the larger Science team's work will continue to ensure Medable is helping create better, easier ways to implement clinical trials that lead to better science and treatments.
