Alimentiv has an over 30-year successful history in the design and conduct of early to late phase inflammatory bowel disease (IBD) clinical trials.
The global prevalence of IBD is increasing. Although major therapeutic advances have been made in IBD, no one therapy is effective for all patients, and a large unmet need remains for more efficacious treatments with favorable safety profiles for both Crohn’s disease (CD) and ulcerative colitis (UC). Historically, therapeutic efficacy has been measured by an improvement in disease symptoms, however clinical remission alone does not reduce the risk of long-term complications, such as surgery and hospitalizations. This contrasts with therapies that induce endoscopic mucosal healing, an objective measure of disease activity that along with patient reported outcomes, is recognized by regulatory agencies as a critical component of drug approval trials. Additional objective outcomes, including histopathology, are near future therapeutic targets.
Alimentiv continues to expand our IBD therapeutic expertise and can support your clinical development program through our:
- Vast global network of IBD clinical investigators
- Highly trained and experienced central endoscopy, histopathology, and radiology readers with expertise in IBD
- Global research consortium focused on operationalizing translational medicine research in multicentre clinical trials
- Experienced team of clinical research associates
- Suite of standard IBD-specific electronic case report forms
- Biostatisticians whose expertise in clinical trials ensures high quality and clinically relevant results
Alimentiv’s history and experience extends beyond the design and conduct of IBD clinical trials. Our academic research has shaped the clinical trial environment. Some of the highlights of this research include:
- Systematic evaluation of the operating properties of endoscopic, histologic and radiologic outcomes for both UC and CD
- Publication of multiple consensus recommendations and standardized scoring conventions for the most valid and reliable indices for assessing UC and CD disease activity in collaboration with internationally recognized experts
- Conclusive evidence for the role of central endoscopy reading to decrease placebo rates and increase the statistical efficiency of clinical trials
- Development of novel patient-reported outcome measures for UC and CD
- Development and validation of the Robarts Histopathology Index, an outcome measure that is routinely used in current drug development programs to assess histologic mucosal healing in UC
- Development of the UC-100, a composite (clinical, endoscopic and histologic) disease activity index intended for early drug development in UC
- Development and validation of MAGNIFI-CD, a magnetic resonance-based outcome measure for radiologic assessment of peri-anal fistulizing CD activity
Click here to learn more about our past and ongoing medical research and development efforts as well as the people who accelerate our client’s clinical development programs.