In dermatology trials, the stakes are uniquely high. Measures of disease severity are inherently subjective and require trained clinical judgment, consistent interpretation, and precise scoring across diverse sites and geographies.
When a biotechnology company approached us to support their Phase 2b atopic dermatitis trial, spanning 110+ sites across more than 10 countries, we knew that maintaining endpoint reliability would be paramount to the success of their trial.
What began as a data analytics engagement evolved into something more comprehensive – a true partnership that demonstrated the power of integrating real-time data quality monitoring with targeted rater training to achieve successful trial outcomes.
The Starting Point: Recognizing the Data Quality Imperative
The sponsor engaged Signant to implement PureSignal Analytics, our clinical outcome assessment (COA) data analytics solution, to monitor data quality throughout their multinational trial.
With over 350 patients, 10 COAs, and assessments conducted in more than 10 languages, the complexity was substantial. The sponsor understood that proactive monitoring would be essential to identify and address data quality risks before they could impact the trial endpoints.
As data began flowing in from sites worldwide, PureSignal Analytics provided both a macro-level overview of the data, coupled with a granular clinical review to detect emerging patterns and clinical significance. Ultimately, these findings would eventually reshape our approach to this trial.
When Data Speaks: Identifying the Training Gap
Real-time monitoring revealed that anomalous data patterns were appearing across multiple sites over time. By analyzing data systematically, we identified inconsistencies in how raters were applying scoring conventions and discordances between scales, that were clinically significant.
Various options were considered on how to rectify these data anomalies. One course of action was to have raters review the original training and re-certify. Prior to the start of the trial, raters were trained by a third-party vendor by accessing remote slide decks.
However, it was decided that a more interactive approach was needed in this case. Raters needed interactive, evidence-based training that would help them understand not just how to score, but also why their scoring decisions mattered.
This is where our partnership with the sponsor deepened. Rather than simply flagging issues, we proposed expanding our scope to include Signant's Rater Training & Qualification solution. This approach enabled us to address the potential data quality issues we were observing in real-time.
Building a Solution Together: The Power of Collaboration
What made this engagement successful wasn't just our technology or training expertise; it was the collaborative approach we took with the sponsor. Together, we designed a targeted training program that addressed the most common data issues identified through our data monitoring.
Our clinical experts developed content that went far beyond generic materials. The training emphasized the differences and relationships between scales, incorporated real-life examples of discordant data (from the trial itself), and helped raters understand the direct impact of accurate scoring on study outcomes. This wasn't theoretical; it was grounded in the actual challenges sites were facing.
We also recognized that timing and accessibility were crucial. High-quality training content had to be developed and deployed quickly to influence ongoing data collection. Some sites couldn't attend investigator meetings, so we offered over 20 online training sessions, ensuring broad coverage across all high-recruiting sites.
The Holistic Approach: Where Analytics Meet Education
What truly set this engagement apart was the integration of two powerful capabilities working in concert.
PureSignal Analytics enabled frequent, systematic monitoring of data that allowed for near real-time detection of data quality issues. This wasn't about catching errors after the fact; it was about identifying opportunities for improvement as they emerged. Our collaborative remediation discussions were tailored to address the specific needs of individual sites or raters before issues could compound or impact broader study outcomes.
Meanwhile, the rater training reinforced these efforts by addressing patterns we observed across the trial. Raters received not just instruction, but understanding – the kind of insight that transforms how assessments are conducted and ultimately strengthens inter-rater reliability.
The Outcome: From Data Quality to Development Success
The results speak to the value of this integrated approach. By combining proactive data quality monitoring with evidence-based rater training, we achieved more than just improved consistency and accuracy in COA scoring. We helped strengthen the foundation of endpoint reliability that the entire trial rested upon.
The sponsor successfully met their primary and key secondary endpoints, advancing their drug candidate to Phase 3. While many factors contribute to trial success, the role of reliable, high-quality endpoint data cannot be overstated, particularly in dermatology, where subjective assessments must be rigorously standardized. The Lesson: Flexibility and Integration Matter
This case reinforces something we see repeatedly in clinical development: the most successful trials are those where sponsors and solution providers work together flexibly, responding to data signals and adapting strategies as needed.
Data quality monitoring isn't just about identifying problems; it's about creating opportunities for intervention. And training isn't just about initial qualification; it's about continuous support that responds to the real challenges emerging in your trial.
When these elements work together, supported by close collaboration between sponsor and provider, the path to proof becomes clearer, more reliable, and ultimately more successful.
Are you facing data quality challenges in your dermatology or other clinician-rated endpoint trials? Our integrated approach to data analytics and rater training can help ensure your endpoints deliver the reliability your development program demands.
Meet the authors
Maria Visser, PhD is a Clinical Scientist at Signant Health, specializing in Phase 3-4 dermatology clinical trials, with a focus on atopic dermatitis, pruritis, and vitiligo. With a Ph.D. in Physiological Sciences and a background in clinical research, Maria leverages their analytical and critical thinking skills to solve complex problems. Known for their effective interpersonal communication, they engage seamlessly with both internal and external stakeholders.
Todd Everhart, MD, FACP is the internal medicine leader at Signant. Dr. Everhart is board-certified in internal medicine and a fellow of the American College of Physicians with over 23 years of experience in the practice of medicine and over 12 years of experience in clinical development. Prior to joining Signant, Dr. Everhart held positions of Vice President, Medical Affairs and Vice President, Medical Informatics at Chilltern and Covance, and consulted independently in the areas of medical monitoring, medical data review, data analytics, and physician adoption of technology. He has worked in all phases of clinical development in numerous therapeutic areas including allergy & immunology, cardiovascular, hematology & oncology, infectious disease & HIV, neurology, ophthalmology, psychiatry, respiratory, and rheumatology.
Marcela Roy, MA, is Executive Director, Clinical Science & Medicine at Signant Health. She has been with Signant for over 15 years and has over 20 years of clinical and research experience. Her focus is Mood Disorders and Endpoint Reliability quality monitoring. She provides strategic direction in the organization, as well as team leadership and business development support.
Dr. Alan Kott is the Practice Leader for Data Analytics at Signant Health, with both academic and industry experience in clinical trials. He has led the development of Signant’s Data Analytics Program, overseeing data analytics in over 200 clinical trials across multiple indications. Prior to joining Signant, Dr. Kott was an Assistant Professor at Charles University and a house officer in psychiatry at General Teaching Hospital in Prague. He holds a Medicinae Universae Doctor (MUDr.) from Charles University.
