We understand the significant challenges sponsors face with patient recruitment in their ulcerative colitis (UC) clinical studies. While the prevalence of UC is relatively high (~0.2% in North America, Oceania and much of Europe – and rising in urbanized/industrialized countries in Africa, Asia and Latin America1), recruitment rates into clinical …
Decentralized Clinical Trials (DCT) Monthly Blog – January 2021
What’s Next? In the aftermath of a turbulent 2020, in which the overall industry perception of the decentralized clinical trial (DCT) approach transitioned from being “promising but still largely experimental” to “a new-normal paradigm for the industry to adopt,” we have been considering “what’s next?”
Decentralized Clinical Trials (DCT) Monthly Blog – December 2020
Welcome to the December edition of the DCT blog. In our final edition for 2020, we look back on an eventful year. As we entered into the year, we had a plan for building on prior successes in patient-centric trial design. We had plans for client outreach and events to …
Is a different recruitment strategy required to enroll RA biosimilar studies? How to succeed despite increasing volume of RA biosimilar development programs
Introduction Although a range of regulatory definitions exist, a biosimilar drug is generally defined as \a biological compound that is highly similar to the reference drug, with no clinically meaningful differences in safety, purity and potency.1,2 In addition, biosimilars can be characterized as reducing healthcare costs while maintaining clinical efficacy …
Minimizing placebo effect in inflammatory bowel disease clinical studies
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 …
Inflammatory bowel disease clinical studies – where do we go from here?
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 …
Finding the Other 90%: Attracting Naïve Patients to RA Studies
A recent study by Tufts Center for the Study of Drug Development, based on a survey of 2,000 physicians and nurses primarily in the United States and Europe, found that 91% of physicians feel ‘somewhat’ or ‘very’ comfortable discussing the opportunity to participate in a clinical trial with patients, but …