DELTA2 guidance on choosing the target difference and undertaking and reporting the sample size calculation for a randomised controlled trial.

Jonathan Alistair CookSteven A JuliousWilliam SonesLisa V HampsonCatherine HewittJesse A BerlinDeborah AshbyRichard EmsleyDean A FergussonStephen J WaltersEdward C F WilsonGraeme MaclennanNigel StallardJoanne C RothwellMartin BlandLouise BrownCraig R RamsayAndrew CookDavid ArmstrongDoug AltmanLuke D Vale

Published in: Trials (2018)

The key messages from the DELTA2 guidance on determining the target difference and sample size calculation for a randomised caontrolled trial are presented. Recommendations for the subsequent reporting of the sample size calculation are also provided.

Keyphrases

clinical trial
study protocol
monte carlo
adverse drug
open label
randomized controlled trial
double blind
placebo controlled
electronic health record