Author: Jill V. Platko PhD, Vice President, Scientific Services
Snapshot:
- Advantages of Timely Data Capture: Accessible reporting methods, that reduce memory-based biases and inaccuracies, are important tools to capture fluctuations in chronic symptoms.
- Calculating Accurate Composite Scores: eCOA provides a single-entry point for diverse data collection, simplifying the site user experience and improving the accuracy of composite scoring in GI Trials.
This post is the third in a three-part series exploring how Electronic Clinical Outcome Assessments (eCOA) streamline the clinical trial process and improve data collection in the fields of oncology, dermatology, and gastroenterology.
Gastrointestinal (GI) diseases encompass a wide range of conditions affecting the digestive tract, from irritable bowel syndrome (IBS) to Crohn’s disease and ulcerative colitis. The complexity and variability of these conditions present specific challenges in clinical trials. Electronic Clinical Outcome Assessments (eCOA) offer advantages for addressing the complexities of GI studies.
Challenges Specific to GI Studies
GI disorders often involve chronic symptoms that fluctuate in intensity and frequency, such as abdominal pain, bloating, diarrhea, and constipation. These symptoms can significantly impact a patient’s quality of life. Paper data collection methods don’t reliably capture accurate data, so site personnel can more effectively get the information they need by using eCOA technology.
Detailed Data Collection from Patients, Clinicians, and Lab Scores
eCOA systems enable detailed tracking of GI symptoms, allowing patients to log their experiences regularly rather than relying on memory to report symptoms later. Patients can use mobile devices to report the severity and frequency of symptoms like abdominal pain and bowel movements.
Beyond patient-reported symptoms, the complex nature of GI disorders means that data is collected from diverse sources at different times. For example, trials for Crohn’s disease may need to collect lab values such as hematocrit from blood samples and physical assessments like mucosal appearance during an endoscopy. This data capture is crucial for GI studies, providing a more accurate picture of the disease and its response to treatment.
Advanced Data Integration
Diverse data sources must then be integrated in order to calculate composite scores, a process that can be cumbersome and error-prone when conducted manually. Suvoda eCOA was designed to respond to this challenge and ease the site experience by being a single-entry point and source of truth for composite score calculations.
Site personnel can harness an eCOA solution to inform study eligibility, patient randomization, or handle shifts in patient status during the course of a trial. This is especially true when eCOA and Interactive Response Technology (IRT) are united on a single technology platform. For example, the Suvoda platform can help facilitate the changes that occur based on whether the patient is responding to treatment.
A Single Source for Data Collection and Calculations
By pulling together diverse data types into a single, reliable source for data collection, calculations, and reference, an eCOA platform becomes an even more powerful tool for organizing data and decision-making. eCOA technology can help enhance data accuracy and overall trial efficiency.
Adopting eCOA isn’t just an upgrade—it can improve the quality of GI clinical trials by enabling accurate patient reporting and high-quality data to assess the effectiveness of experimental therapies.
Author
Jill V. Platko PhD
Vice President,
Scientific Services
Suvoda
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