What Is Needed for Laboratory Data in Multi-Regional Clinical Trials
Osamu, K.
Rinsho Byori. Japanese Journal of Clinical Pathology 64(5): 555-557
2016
ISSN/ISBN: 0047-1860 PMID: 30695367 Document Number: 688659
Laboratory data are used to check patient eligibility, judge a change in medication, and evaluate the efficacy and safety of a test drug, and they comprise an important part of clinical trial data. Although a central labora- tory model has been adopted since the early 1990s to minimize inter-site variability, local laboratories are still important and often necessary for many reasons. Because it is not rare for many countries to participate in multi-regional clinical trials, "whether data from different countries or different sites could be handled as if those data were obtained from a single site" is a challenge in such clinical trials. Here, it is very important for sites to be ready to state that their laboratory has no problems with pre-analysis, analysis, or record stor- age to-a third party. [Review].