title: Controversies about sponsor initiated re-analyses of clinical trial data in the licensing process.
abstract: I present my experience with sponsor initiated re-analyses as a response to the regulatory agency's 'Mängelbericht', and the difficulties which arose from the fact that the regulatory agency was not involved in the plans for correcting mistakes or irregularities in the data and for the (re-)analysis of them. I also discuss the related problem when there are major discrepancies between the planned procedures laid down in the protocol and the actually applied procedures in the study report. I give examples for poor planning of a clinical study (sample size, statistical analysis, target variable(s)) and how this reduces the strength and value of a study. I introduce the phrase 'neutral party' as a means to resolve regulatory concerns about partiality in the sponsor's decisions, for example, introduction of new statistical models, different from the one planned, change in the order of the target variables, or dropping variables from the list of target variables.
authors.affiliation: Federal Institute for Drugs and Medical Devices, Seestrasse 10, 13353 Berlin, Germany.
authors.forename: J
authors.initials: J
authors.lastname: Röhmel
mesh_terms: D002986:Clinical Trials as Topic / Q000706:statistics & numerical data*; D003627:Data Interpretation, Statistical; D017277:Drug Approval / Q000331:legislation & jurisprudence / Q000379:methods / Q000706:statistics & numerical data*; D005858:Germany; D006801:Humans; D008954:Models, Biological; D015337:Multicenter Studies as Topic; D018401:Sample Size