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Operational challenges and solutions with implementation of an adaptive seamless phase 2/3 study.
J Diabetes Sci Technol · 2012
Last updated 2026-05-28A diabetes drug study used an adaptive trial design, which required more planning and coordination than a standard study. The trial involved nine different drug doses across many global sites, needing careful management of drug supplies. Rapid data collection and analysis were also critical to the study's success.
AI summary of the abstract below.
| Journal | J Diabetes Sci Technol, 2012 |
|---|---|
| Citations | 14 |
| Relative citation ratio | 0.53 |
| NIH percentile | 31 |
| Molecules | — |
Abstract
A wide variety of operational issues were encountered with the planning and implementation of an adaptive, dose-finding, seamless phase 2/3 trial for a diabetes therapeutic. Compared with a conventional design, significant upfront planning was required, as well as earlier, more integrated cross-functional coordination. The existing infrastructure necessitated greater flexibility to meet the needs of the adaptive design. Rapid data acquisition, analysis, and reporting were essential to support the successful implementation of the adaptive algorithm. Drug supply for nine treatment arms had to be carefully managed across many sites worldwide. Details regarding these key operational challenges and others will be discussed along with resolutions taken to enable successful implementation of this adaptive, seamless trial.
Verbatim abstract via PubMed 23294774 ↗