Before a clinical trial can commence a protocol - a plan of exactly how a trial will be conducted - will be formulated. As part of the planning, the individuals undertaking the trial will calculate approximately how many patients need to take part for the results

http://www.helenjaques.co.uk/blog/2008/are-researchers-fudging-clinical-...

Discrepancies in sample size calculations and data analyses reported in randomised trials: comparison of publications with protocols. Chan AW (2008) BMJ.
Bias, spin, and misreporting: time for full access to trial protocols and results. Chan AW (2008) PLoS Med.
December 12, 2008