It’s been 50 years since Schwartz and Lellouch(1) first introduced the concept of pragmatic clinical trials (PCTs) and now major changes in the EU(2) and USA(3) regulations have made the conduct of these PCTs more favourable, but who, if anyone, is conducting them and what challenges are they facing?
Please take this short anonymous survey to help us understand how many PCTs are being conducted and what challenges you are encountering.
Deadline = Monday 17 April 2017
From challenges come solutions!
(1) Schwartz D, Lellouch J. Explanatory and pragmatic attitudes in therapeutical trials. J Chronic Dis. 1967 Aug;20(8):637-48.
(2) The European Clinical Trials Regulation – Regulation EU/536/2014: Refer to “Low Intervention Trials”
(3) The 21st Century Cures Act – H.R. 34 (114th): Refer to Section 3022