Medidata Blog
Improving Ulcerative Colitis Treatment Using the Mayo Score and Electronic Clinical Outcomes Assessment in Clinical Trials
The Mayo Score has been a long-established assessment tool within clinical trials designed to measure the severity of ulcerative colitis (UC). There is currently no known cure for UC, and patients that suffer from ulcerative colitis are often faced with managing a chronic condition that includes a number of symptoms, including abdominal pain, diarrhea, weight loss, and fatigue.
Four components go into calculating the Mayo Score. There are two patient-reported outcomes that study participants track via diary entries: 1) the number of daily stools compared to their norm during periods of remission and 2) the frequency of rectal bleeding. The other two components are: 3) the results of an endoscopic examination of the mucosa and 4) a physician’s assessment incorporating the first three components along with the patient’s condition and general ability to function.
In the United States, the Food and Drug Administration recommends that sponsors of clinical trials for ulcerative colitis treatments use assessment tools such as the Mayo Score, administered electronically, to document whether, and by how much, the treatment being tested is beneficial to patients.
Meaningful changes in the Mayo Score, such as a two-point improvement on the 12-point scale, are the primary endpoint for many clinical trials of ulcerative colitis treatments. During clinical trials, investigators can also use the Mayo Score to guide changes in participants’ medicine dosage or switch them to a different treatment arm, according to what the study protocol specifies for patients who are not benefiting or are experiencing serious side effects. Additionally, some studies use only two or three of the Mayo Score components, as some trial protocols don’t require all four.
When embarking on ulcerative colitis clinical trials, it’s important to consider the following key factors:
- Is your eCOA (electronic clinical outcome assessment) solution unified with your EDC (electronic data capture) system?
- Does your patient, clinic, and lab data all flow into a single location?
- How intuitive is the eCOA diary for patients to use?
- Do you have a long-term plan to incorporate patient (and potentially caregiver) reported outcomes into a broader decentralized clinical trial (DCT) strategy?
Medidata’s eCOA tool is the only eCOA solution that is unified with Medidata Rave EDC—the industry’s most advanced, robust, and secure EDC system for clinical trial site, patient, and lab data capture and clinical trial data management. With Medidata eCOA, there is no longer a need for duplicative data entry, data migrations, or harmonization efforts to enable quality clinical trial data capture and consistency in real time.
Whether running hybrid or fully decentralized clinical trials, engaging and retaining patients throughout the course of a trial is imperative to long-term success. That’s why Medidata ensures the electronic diaries in which participants enter their clinical outcomes assessments are easy to use and transmit directly to Rave EDC for investigator review. Selecting a DCT vendor that provides a single, turnkey experience is crucial. Only Medidata Patient Cloud® delivers an end-to-end experience that supports the entire patient journey from start to finish, making trials faster and more successful by reducing burdens for both patients and site staff.
How should you get started? When embarking on clinical trials for ulcerative colitis, be sure to consider these important points: The Mayo Score is a vital measure in the assessment of UC, and ultimately the measure of success for potential new treatments. While on the face of it, an assessment made up of only four components should be relatively straightforward, it’s important to keep in mind that these components are from disparate sources—patient, clinician, and lab. Thus, bringing together these data points in a timely and accurate manner is vital for a successful Mayo Score solution in a clinical trial. And, of course, making sure patients have a simple, low-friction e-diary for entering their daily data across the course of the study will lower burden and ultimately ensure a better trial for all stakeholders.