Guidelines from the International Conference on Harmonization

Adding to this problem is the lack of unambiguous, scientifically valid guidelines from the International Conference on Harmonization (ICH) guidance (1). This leads to having to choose between what the user thinks the regulators want and the scientific approach. 

There are a number of Western publications, as well as materials from various conferences (Droujinine 1996 Loran et al. 1996 Sinackevich 1997), that address clinical trials in Russia. It is important to mention the appearance of the new Instructions. .. as well as adopting the International Conference on Harmonization Good Clinical Practice (ICH GCP) as the major guidelines for conducting clinical trials by the Russian MOH (12 August 1997). 

All chapters have been brought up to date in the new edition and in particular, there is extensive reference to various guidelines of the International Conference of Harmonization that have been issued since the first edition, in particular ICH E9, Statistical Principles for Clinical Trials. A new chapter on pharmaco-genetics has been added. For the reader in possession of a first edition who wishes to know whether to splash out on a second, Figure P.l may be helpful. (This is partly so that I can underline the fact that nothing in life, not even an author s preface, should be exempt from statistics ) This compares the two editions chapter by chapter in terms of their length in thousands of words. 

---