eDiary Feasibility in Pediatric Seizure Trials: Findings Across Three Multi-Center Studies

Capturing accurate seizure data in pediatric rare disease trials presents unique challenges that can make or break endpoint integrity. A recent analysis of electronic seizure diary (eDiary) usage across three multi-center studies demonstrates that digital reporting is feasible in these complex populations and may offer advantages over traditional paper-based approaches. 

The Paper Diary Problem in Pediatric Seizure Trials 

Paper-based seizure diaries have long been the standard for capturing seizure episodes in clinical trials, but in pediatric populations, especially those with rare neurological conditions, they create significant burdens that compound quickly. 

The physical fragility of paper is a practical problem from the start. Diaries can be damaged, misplaced, or rendered unusable at precisely the moments they're needed most. For parents and caregivers already managing complex medication regimens, therapy appointments, and the unpredictable nature of seizures, the cognitive load of tracking events on paper is substantial. Seizures frequently occur at night or during high-stress situations when locating a diary and recording details are not realistic, particularly when the caregiver's priority is the child, not the record, which can often result in delayed or missed diary entries rather than true real‑time reporting. 

 The data quality consequences of paper seizure diaries are well documented. High eDiary completion rates in these pediatric epilepsy studies (average 92.3%) stand in sharp contrast to the much lower real‑world compliance typically seen with paper diaries 1,2, where retrospective ‘parking lot’ entry and associated recall bias remain persistent concerns. In rare disease trials, small sample sizes make every data point critical; incomplete or delayed entries can obscure true treatment effects and compromise endpoint reliability. Manual transcription of paper diaries into study databases introduces yet another avoidable source of error. 

Why This Matters for Rare Disease Drug Development 

The limitations of paper reporting have real implications for trial success. Near-real-time electronic capture with verifiable timestamps can enhance regulators’ confidence in seizure data, potentially reducing questions during review. Eliminating paper collection, transcription, and query resolution accelerate timelines, which matters enormously for rare disease trials where families are waiting for potential treatments. Further, reducing caregiver/eDiary keeper burden through intuitive digital tools can improve retention in studies where every enrolled patient represents significant recruitment effort. 

Electronic systems also shift workload away from site staff by automatically capturing and transmitting data, allowing study teams to focus on successful trial execution rather than data management under real‑world trial conditions. 

Why Electronic Diaries Are Different — Especially for Rare Pediatric Populations 

Signant Health's seizure eDiary was developed in collaboration with The Epilepsy Study Consortium, bringing decades of epilepsy research expertise into the design. This partnership informed the design of an eDiary that captures clinically meaningful seizure data while reducing eDiary keeper burden, which is critical for rare disease populations where recruitment is already challenging. 

Unlike paper, smartphones and similar devices are familiar tools that caregivers carry with them throughout the day. They are not easily damaged or truly lost, and—as later results show— eDiary keepers’ high completion rates and rapid entry times suggest that timely use poses no difficulty. A recent analysis examined eDiary performance across three multi-center studies in pediatric rare disease populations, including lysosomal storage disorders, to evaluate how electronic reporting holds up in even the most complex trial designs. 

Real-World Performance: What the Data Show 

The findings across all three studies were consistent and striking:

• eDiary compliance ranged from approximately 88% to 95%, with an average compliance of 92.3%, exceeding typical paper diary compliance rates reported in epilepsy studies.

• Median completion time was approximately 12 seconds, with a narrow interquartile range (~9-22 seconds), supporting the conclusion that ease of use translates directly to reduced caregiver burden.

• Caregivers in three pediatric epilepsy trials are expected to log over 70,000 days of seizure eDiary entries, showcasing just how powerfully engaged and reliable daily digital reporting can be at scale. 

The speed of entry is particularly telling. The usability of the electronic solution likely contributed to the high compliance rates observed; a meaningful finding for trial teams weighing digital implementation. 

Challenges in Pediatric Rare Neurology Trials 

The performance data above is especially significant given the environment in which these eDiaries were deployed. Rare pediatric neurological conditions present a convergence of trial design challenges that make reliable data collection unusually difficult. 

Patient populations are small and heterogeneous by nature. When pediatric age restrictions and specific neurological phenotypes are layered on top of a rare disease definition, enrollment becomes highly constrained, and every participant's data carries outsized importance. Seizure presentations in these disorders may also differ meaningfully in type, frequency, and severity from more common epilepsies, requiring caregivers to report nuanced details that are genuinely difficult to recall hours or days later. 

The caregiving context adds further complexity. Parents managing rare pediatric neurological conditions are often coordinating across multiple specialists, navigating complex medication schedules, and handling insurance and school accommodations — all while coping with the emotional weight of their child's condition. Regulators have increasingly scrutinized paper-based seizure reporting in this context, particularly when compliance cannot be verified, and recall bias is likely. The eDiary data from these three studies, with objectively timestamped entries and high day-level completion, speaks directly to that concern. 

Looking Ahead: Digital Solutions for Complex Populations 

The strong performance of seizure eDiaries in these pediatric rare disease trials challenges a persistent assumption: that complex or vulnerable populations require simpler, paper-based data collection. The evidence suggests the opposite. Thoughtfully designed digital tools can improve data quality and reduce burden compared to traditional approaches. 

For sponsors designing trials in pediatric epilepsy, rare neurological disorders, or other seizure-related indications, these findings support eDiary implementation as a strategy to strengthen endpoint integrity, de-risk seizure outcome measurement, and better support the families at the center of these studies. 

Why This Matters 

For sponsors, this combination of higher compliance, verifiable timestamps, and reduced site workload translates into stronger primary endpoints, fewer data queries, and more predictable trial timelines. 

View the Poster →

About the authors

Dr. Figueroa is a Clinical Scientist with the eCOA Science Team at Signant Health, where she leverages her extensive expertise in electronic Clinical Outcome Assessments (eCOA) across diverse therapeutic areas, including oncology, dermatology, and infectious diseases. With over a decade of translational research experience, Dr. Figueroa is dedicated to advancing the field of clinical trials and improving patient outcomes through innovative methodologies and strategic insights. Her work at Signant Health focuses on integrating cutting-edge eCOA technologies to enhance the accuracy and reliability of clinical data, ultimately contributing to more effective and patient-centric healthcare solutions.

Greta van Schoor, PhD provides scientific expertise and guidance relating to the implementation of electronic clinical outcome assessments (eCOAs) and has a special focus on eDiary design and accessibility of eCOA best practices. She completed her PhD in Physiological Sciences at Stellenbosch University, which focused on the bacterial and inflammatory involvement in colorectal carcinogenesis, and has 3+ years’ experience in the clinical research industry. She has given scientific consultation for projects across a wide range of therapeutic areas, including oncology, infectious disease, dermatology, and gastroenterology. 

Dr. Busner has over 35 years of experience as an academic psychiatric researcher, serving as Principal Investigator for 49 clinical trials and Sub-Investigator for 35 more. She has authored or co-authored over 140 peer-reviewed articles and presentations. Before joining Signant Health, she directed psychiatric clinical trials at two major medical schools and served on University IRBs for 20 years. Currently an Affiliate Associate Professor of Psychiatry at Virginia Commonwealth University, Dr. Busner leads studies at Signant on pediatric, rare, and psychiatric disorders, and has trained thousands of clinical trial investigators worldwide. 

Lewis M. Fredane, MD, is the Clinical Vice President at Signant Health, serving as the Therapeutic Area Leader for neurology. He oversees Signant’s eCOA, Rater Training, and Quality Assurance in this field. Previously, Dr. Fredane was a practicing neurologist and clinical assistant professor at Drexel University College of Medicine. He has experience in pharmaceutical drug development with companies like Sanofi/Genzyme and Meda Pharmaceuticals and has worked with CRO Omnicare Clinical Research.