Volume 150, Issue 5, Pages 1061-1066 (May 2016) How Failure Can Fuel Improvements in Early Drug Development for Inflammatory Bowel Diseases  Stefan Schreiber  Gastroenterology  Volume 150, Issue 5, Pages 1061-1066 (May 2016) DOI: 10.1053/j.gastro.2016.03.011 Copyright © 2016 AGA Institute Terms and Conditions

Figure 1 Exemplary relationship between exposure (blood levels) and efficacy for biological investigational medicinal products. Trough levels of golimumab in patients with ulcerative colitis represented by quartiles and their association with response (left) and remission (right).4 Gastroenterology 2016 150, 1061-1066DOI: (10.1053/j.gastro.2016.03.011) Copyright © 2016 AGA Institute Terms and Conditions

Figure 2 Re-randomization (A) versus treat through design (B). Re-randomization designs (A) require an early read for response, which will interrupt the further comparison with the original placebo populations. The early read for response may be too early to assess objective parameters like mucosal healing. Treat-through designs (B) are easier to include step up algorithms for dosing. Objective assessments of efficacy can be made at any time point as no re-randomization disturbs the flow of patients. Treat-through designs can use an active comparator instead of placebo. Gastroenterology 2016 150, 1061-1066DOI: (10.1053/j.gastro.2016.03.011) Copyright © 2016 AGA Institute Terms and Conditions