This study uses the data from many of the mandatory fields in ClinicalTrials.gov to examine changes, possibly leading to more complexity in the design and execution of commercially sponsored phase 3 clinical trials.
Methods:
In this analysis we compare baseline year 2008 data, when a broad number of the protocol/study design and execution variables became mandatory, with the data from the last full year of results, 2013.
Results:
There has been relatively little change in the protocol and study design over the years covered in this study. The most pronounced change is associated with single-patient duration: there is a significant increase in the period of time a patient is treated in the study protocol. The study also highlights an important methodological issue: many of the claims in print about complexity have yet been substantiated through the use of peer-reviewed data or in settings where others can interrogate the results.
Conclusions:
In general, there is limited evidence for significant increases in the study and protocol design and execution of phase 3 clinical trials sponsored by pharmaceutical companies.
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