The management of interim analyses in drug development by Karen M. Facey and John A. Lewis, Statistics in Medicine, 17, 1801–1809 (1998)

✍ Scribed by James R. Anderson; David Harrington

• Publisher: John Wiley and Sons
• Year: 1999
• Tongue: English
• Weight: 49 KB
• Volume: 18
• Category: Article
• ISSN: 0277-6715
• DOI: 10.1002/(sici)1097-0258(19990815)18:15<2063::aid-sim189>3.0.co;2-w

✦ Synopsis

We read with interest the review by Facey and Lewis of procedures for the design and management of clinical trials involving interim analyses. The authors rightly emphasize the need for interim monitoring of studies of life-threatening illnesses, to allow early termination if compelling di!erences in outcome by treatment are identi"ed. However, we believe that interim monitoring by an external Data and Safety Monitoring Committee should be a part of all randomized comparative trials of e$cacy and that the present guidelines of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) are wrong to suggest that interim monitoring is only required when studying life-threatening diseases.

The ICH was organized by regulatory authorities and industry associations of the European Union, Japan and the United States of America in order to promote international harmonization of regulatory requirements for drug development.

ICH tripartite harmonized guideline, Statistical considerations in the design of clinical trials', was adopted in February 1998 and designed to address statistical principles of clinical research of investigational products, and facilitate the acceptance of analyses and conclusions from these trials by regulatory agencies. Some of the U.S. pharmaceutical industry use this guideline to direct the conduct of ongoing research.

Section 4.5 of this document (interim analysis and early stopping) states:

LETTER TO THE EDITOR