PLoS Medicine
(Accessed 16 June 2012)
http://www.plosmedicine.org/article/browse.action?field=date

Protecting Clinical Trial Participants and Protecting Data Integrity: Are We Meeting the Challenges?
Susan S. Ellenberg
Essay, published 12 Jun 2012
doi:10.1371/journal.pmed.1001234

Summary Points
– Although there is substantial consensus regarding the need for interim monitoring of certain types of trials, there is controversy about specific aspects of data monitoring.

– Approaches to ensuring independence of those who perform the interim monitoring and confidentiality of interim data vary substantially by type of trial and trial funder.

– The “independent statistician” model, involving a separate statistician to analyze interim data and report to the data monitoring committee (DMC), remains controversial but provides important protections of data integrity.

– Early stopping guidelines should be clearly understood and accepted by all parties, and only deviated from if there are unexpected findings that confound the overall benefit-risk assessment at interim analysis.

– Liability of DMC members is an important concern that has not been dealt with adequately by either commercial or government trial sponsors.