Clinicians and researchers face a unique set of challenges during the development for the treatment of Gastroenterology disorders. One of these challenges is the rigorous requirements imposed by regulatory bodies on all phases of drug development. Due to exploding trial activity in this arena, competition for subjects has increased, particularly for those with unique clinical characteristics. Patient retention can be difficult in long-term studies. Sizeable placebo response rates have been observed in psoriasis, rheumatoid arthritis (RA), and ulcerative colitis (UC) trials. Patient-reported outcomes (PROs) are receiving broader attention across IMIDs. For example, the FDA is focusing more on PROs for inflammatory bowel disease.
Worldwide’s key areas of Gastroenterology specialty include:
Worldwide Clinical Trials’ team of experts can guide you through regulatory requirements, development of complex study and protocol designs, and recruitment of eligible patients to implement the study protocol. Our team of therapeutic experts have extensive experience with global, pivotal gastroenterology Phase I – IV studies across multiple indications.