Technological developments and advances in medical knowledge affect the evolution of how disease activity can and should be measured. In the clinical trial setting, decisions regarding the method, modality, and timing for assessment of disease activity have fundamental consequences on both trial efficiency and outcome.
In the current era, emphasis is further placed on the need for both objective disease measures as well as those that are relevant to patients. A contemporary dilemma facing trials in many disease areas, including gastrointestinal diseases, is the gap between this need and validated instruments that achieve these goals. Bridging this gap in inflammatory disease has involved a substantial research investment and has been a long-term academic focus at Alimentiv. We are pioneers in the development and validation of both the outcome measures and technology that are shaping the evolving clinical trial landscape for multiple indications.
We have created major research consortiums in collaboration with internationally recognized therapeutic experts, to identify disease-activity measures that are relevant to the underlying disease pathobiology, as well as those that are critical to patients. Together we are working towards standardizing and validating these measures as outcomes that will provide meaningful long-term consequences for patients, their treatment, and for society. Our findings are operationalized into superior clinical trial methodology for our clients that is in-line with emerging regulatory standards.
Our ongoing collaborative research is addressing unmet needs for numerous indications (Crohn’s disease [including pediatric and adult perianal fistulizing disease, as well as fibrostenosing and post-operative disease], ulcerative colitis [including pouchitis], eosinophilic esophagitis, non-alcoholic steatohepatitis) and is focused on multiple modalities (clinical, endoscopic, histologic, radiologic) for assessment, and the potential for development of core outcomes sets.