With 93 Crohn’s Disease
(CD) and 168 Ulcerative Colitis (UC) Phase I-III industry-sponsored studies planned
and open to enrollment, there is a significant focus on research into new
therapies for inflammatory bowel disease (IBD)1.
Remission is the main aim of IBD therapy, but IBD studies often face challenges with minimizing the placebo effect2,3,4. Placebo effect can be categorized into placebo response/benefit (patients demonstrating an improvement) or placebo remission (patients achieving remission). Factors believed to impact the level of placebo effect can be contradictory depending upon whether a study’s focus is upon placebo response/benefit or placebo remission5.
Inflammatory bowel disease (IBD), incorporating Crohn’s disease (CD) and ulcerative colitis (UC), is a chronic relapsing-remitting inflammatory disorder of the gastrointestinal tract.1 There is currently no cure for IBD and available treatments (e.g. aminosalicylates, immunosuppressant, biologics) have variable degrees of efficacy and tolerance. As a consequence, there is a large focus upon the development of new drugs for the treatment of IBD. While this is undoubtedly a welcome fact for patients and their families, the current level of research activity brings logistical challenges when conducting clinical trials. Continue reading
Facing ever-increasing costs of running a clinical trial, sponsors must ensure they are properly directing their budget and resolving the areas of highest risk while maintaining patient safety and data integrity.
How can sponsors implement a robust process to allow earlier identification of emerging risks during the course of a trial? This article covers five tips for defining risk levels, categorizing risk and maintaining oversight to ensure that risks and responses are appropriately identified, documented, tracked and managed throughout the life cycle of a study. Continue reading
Rheumatoid arthritis (RA) is an autoimmune disease primarily affecting the musculoskeletal system with typical symptoms including swollen and painful joints, joint stiffness and loss of function, ultimately leading to disability if untreated. RA also produces significant systemic affects such as fatigue and depression that may appreciably impact quality of life for many patients. Prevalence varies between 0.3 – 1.0% and is more common in women and in developed countries.1