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Completing the Clinical Picture: Why Participant-Reported Data is Essential

  • Writer: Shae Wilkins
    Shae Wilkins
  • Jan 22
  • 4 min read

Updated: Mar 31

A conversation with Tryal CEO, Shae Wilkins


Is eCOA essential in modern clinical trials?

While wearables and laboratory tests excel at collecting objective clinical data, they tell only part of the story about whether or not an experimental therapy is helping a participant. Clinical Outcome Assessments (COAs) can play an important role in painting a fuller picture of the participant’s health by helping assess how the participant feels and functions during the therapy being studied. 


A recent JAMA (Journal of the American Medical Association) article cited a study of oncology trials that highlights how incorporating participant-reported outcomes into clinical trials provides crucial insights into symptoms that are often invisible in lab or wearable data. These metrics enhance our understanding of treatment impact and guide care improvements so interventions meaningfully improve participants’ quality of life.


Most notably, the study emphasized the need for direct input from participants to accurately assess symptoms and health-related quality of life (HRQoL). Furthermore, the integration of patient-reported outcome measures (PROMs) into cancer care was associated with improved overall survival and HRQoL.


These findings highlight the transformative potential of patient-reported outcomes (PROs) in delivering more effective and participant-centered care. Without direct participant insights, treatments that look successful on paper may fail to deliver meaningful improvements in participants' daily lives. A treatment's true value lies not just in improving clinical markers, but in enhancing the participant’s ability to live a fuller, more comfortable life.


Critics argue that participant-reported data is unreliable compared to wearables or lab-based data. What's your response?

This criticism overlooks a fundamental truth: participants are the foremost authorities on their own experiences. Validated eCOA solutions provide reliable, meaningful data that complement objective measurements. eCOA can enhance data quality by standardizing the collection process and eliminating potential inconsistencies, allowing participants to report their experiences without external influence.


The most comprehensive understanding of a treatment's impact emerges when study teams combine eCOA with other tests. This offers a holistic view that includes objective measurements and the lived participant experience.


I worked on a study in 2004 where the lead physician noted that “This patient has 25% better lung function but the side effects are making him extremely nauseous. So who cares if he can now walk to work if it's only to vomit when he arrives.”  We have to ask the participants how they feel while on the therapy.


Do regulatory bodies require the use of eCOA in clinical trials?

It is not a strict requirement, however, it has emerged as best practice and is highly encouraged by regulatory bodies. The FDA has emerged as a powerful advocate for incorporating COAs into clinical trials, issuing its own guidance that supports and encourages the use of eCOAs in clinical trials.


For instance, the FDA's guidance on "Electronic Source Data in Clinical Investigations" promotes capturing source data electronically to streamline and modernize clinical investigations. This guidance is intended to assist in ensuring the reliability, quality, integrity, and traceability of data from electronic sources to regulatory submissions.


Their guidance emphasizes that PROs offer crucial insights into treatment impacts that cannot be captured through traditional clinical measurements alone.


How does integrating eCOA with lab tests and wearables improve the data?

This integration creates a three-dimensional view of participant health. While wearables and lab tests provide crucial objective metrics—such as blood pressure, step counts, lung function, and blood composition—they don’t measure more subjective experiences like pain intensity, fatigue levels, or mental/emotional well-being as well as COAs might. eCOA bridges this gap by systematically documenting participants' lived experiences with their conditions and treatments.


By collecting data through multiple complementary approaches, we can develop a complete picture of treatment outcomes that encompasses both physical and psychological dimensions. Using eCOA in clinical research ensures we capture the crucial subjective aspects of participant experience that might otherwise go unrecorded and therefore unincorporated into a clinical data set submitted for the approval of a new therapy.


How do patient advocacy groups view eCOA?

Patient advocacy groups are proving to be strong proponents of eCOA implementation and actively collaborate with initiatives such as the Critical Path Institute’s (C-Path) consortia, including the PRO Consortium and the Rare Disease Clinical Outcome Assessment Consortium. These programs unite patient advocacy groups, industry leaders, and regulatory agencies to develop and validate clinical outcome assessments that accurately reflect participants’ daily realities.


By placing participant input at the heart of drug development, these collaborations help ensure that new treatments address clinical benchmarks, as well as the personal, lived experiences of participants. This approach aligns with FDA guidance emphasizing participant-centered care and underscores the vital role of participant advocacy in advancing therapies that meaningfully improve quality of life.


How is the eCOA market evolving, and what factors are contributing to its projected growth?

The eCOA market is experiencing significant growth, driven by the increasing adoption of digital solutions in clinical trials and the rising emphasis on participant-centric healthcare. As of 2024, the market was valued at between USD 1.8-2.24 billion and is projected to reach USD 3.9-4.5 billion by 2029, reflecting a compound annual growth rate (CAGR) of over 16.6% during this period.  


Several key factors are contributing to this robust growth:


  • Advancements in AI and Gene Therapy: The development of gene therapies has accelerated, with Artificial Intelligence (AI) playing a pivotal role in enhancing the design and delivery of these treatments at a pace not seen in the past.


  • Participant-Centric Approaches: There is a growing emphasis on incorporating participant-reported outcomes into clinical trials to ensure that new treatments address both clinical requirements and personal outcomes. This shift aligns with FDA guidance on participant-centered care and underscores the importance of participant input in drug development.


References
About Shae

Shae Wilkins is a recognized innovator in clinical research technology, bringing over 22 years of entrepreneurial leadership experience to his role as CEO of Tryal.


Connect with Shae on LinkedIn.

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