POC studies (phase 2A) are often categorized as the first confirmatory trial in a drug development program, and it is not uncommon that the primary analysis is similar to the analyses used in the phase 3 trials.
We propose an adaptive design that allows us to expand an ongoing Phase 2 trial into a Phase 3 trial to expedite a drug development program with fewer patients.
This pooled analysis of four phase III clinical trials from the clinical development program has demonstrated that linagliptin significantly reduced albuminuria from baseline by 28% compared with placebo after 24 weeks of treatment.
Among some phase 2 and phase 3 trials in the dapagliflozin development program there was a small excess in event rates for male bladder cancer and female breast cancer over rates expected of the age-matched diabetic population [ 71, 78].
The efficacy and safety of dapagliflozin as monotherapy and as add-on/combination therapy with existing antidiabetic treatment in patients with diabetes mellitus has been established in a series of phase II and III trials in the clinical development program and is supported by five recently published comprehensive reviews or meta-analyses [ 37– 41].
Eight cases were reported during intermediate- and long-term trials in the liraglutide clinical development program.
The data used in the analysis were gathered across multiple clinical trials conducted during the clinical development program for ecallantide.
Aggregated safety data were pooled from the five Phase IIb and III trials which comprised the clinical development program for TPV/r.
The risks for renovascular effects in prior trials of the etoricoxib clinical development program were low with a shallow dose response and were generally similar to those found with naproxen or ibuprofen [ 16].
Collaboration among participating sites including the provision of registry data tailored to the planned development program will optimize trial conduct.
