This article describes guidelines for interim data review for industry-sponsored clinical trials. Interim data review includes all types of data review during the progress of a clinical trial that do not affect the statistical design (type I error adjustments) or statistical conduct (such as decisions to stop for futility or superiority based on hypothesis tests) of the trial. A set of levels of interim data review are described and procedures are given for documentation of the interim data review by the sponsor. A discussion of sponsor risks related to interim data review is included in the article along with recommendations for sponsor conduct of interim data review.
PMA Biostatistics and Medical Ad Hoc Committee on Interim Analysis. Interim analysis in the pharmaceutical industry. Control Clin Trials. 1993;14:160–173.
2.
JennisonCTurnbullBW. Group Sequential Methods With Applications to Clinical Trials. Boca Raton, FL: Chapman and Hall/CRC; 2002.
3.
ChowS-CChangM. Adaptive Design Methods in Clinical Trials. Boca Raton, FL: Chapman and Hall/CRC; 2007.
4.
International Conference on Harmonization. Statistical Principles for Clinical Trials, E9. 1998. Available at: http://www.fda.gov/cder/guidance.
5.
GellerNLPocockSJ. Interim analysis in randomized clinical trials: ramifications and guidelines for practitioners. Biometrics. 1987;43:213–223.
6.
FaceyKMLewisJA. The management of interim analyses in drug development. Stat Med. 1998;17:1801–1809.
7.
O'NeillRT. Regulatory perspectives on data monitoring. Stat Med. 2002;21:2831–2842.
