Virtual Clinical Trials in IBD

Inflammatory Bowel Disease is an umbrella term that groups two disorders of the digestive tract that involve inflammation: Ulcerative Colitis and Crohn’s disease. These two diseases have a lot of symptoms in common like diarrhea, rectal bleeding, abdominal pain, fatigue and weight loss. In the most severe form, they can create life-threatening complications and in all the cases it has a very high impact on the sufferers.

Healint’s objective is to help patients live a better life. One of the ways to reach this goal is to help new treatments reach the market as soon as possible. We have built a platform that dramatically accelerates clinical trials at every stage: from design to report, from recruitment to query management, from compliance to data collection. The proportion of our 3 millions pool of patients that suffer from IBD is similar to the general population. We can recruit patients that fit the most with your protocol, wherever they are in the countries in which the study is conducted.

With regards to the study conduction, we have built a powerful data collection system that gathers Patient Reported Outcomes, but also data provided by the investigator. The logic-check and edit-checks performed by our algorithms increase the quality of the data, which is crucial, in a therapeutic area where the efficacy margin is sometimes small.

CDAI

(Composite: PRO+ClinRO+Lab)

The Crohn’s Disease Activity Index is the most used scale in clinical trials for this pathology. Patients have to record daily, for the past 24 hours, the number of bowel movements with liquid or very soft stool, the abdominal pain level (0 to 3) and the general well being (0 to 4). The scale also takes into account the hematocrit, the presence of related symptoms (arthritis, uveitis, fistula…), the weight, the anti-diarrheic intake. All these parameters are completed in a single eCRF for each patient. Our data collection tool automatically runs the calculation algorithm based on this input, in order to establish a CDAI score, which dramatically reduces the number of human errors in the calculation.

DAI/Mayo Score

(Composite: PRO+ClinRO+Lab)

The Disease Activity Index for Ulcerative Colitis is the most widely used scale in clinical trials for this pathology. It measures stool frequency compared to normal, rectal bleeding, and also the mucosal appearance at endoscopy. The physician rating of disease activity is also taken into account in the calculation. The algorithm is less prone to error than for the CDAI, since it is a simple sum, but our tool allows to gather all the elements in one place and dramatically reduce data reconciliation time by ensuring that all the data really correspond to the same patient.