Quantifying the magnitude and cost of collecting nice-to-have clinical trial data

摘要

In 2013, Getz et al demonstrated that biopharmaceutical companies are implementing protocol procedures that do not support the primary and key secondary endpoints of the clinical study. The research results indicated that between 18% and 24% of all procedures supported supplemental secondary, tertiary, exploratory or no (i.e. non-core) endpoints. More granular information about non-core procedures, however, was not collected in the 2013 study. That study also did not assess whether those procedures supporting primary endpoints were collected excessively. As a follow-up, between June and October 2013, the Tufts Center for the Study of Drug Development conducted a study among a working group of eight pharmaceutical companies in which a total of 11,923 individual protocol procedures were analyzed. Results indicate that 36.0% (standard error 5.1%) of all procedures supporting non-core endpoints cannot be tied to a specific reason for being in the protocol. 1.4% of all procedures collected to support core endpoints are collected in excess.