This discussion emphasizes specification of subgroup analyses in the protocol and adjustment of the resulting p-values. The perspective is that of a statistician in the pharmaceutical industry. These comments are derived primarily from discussions with people from various companies, as well as the author's personal experience. These comments do not necessarily represent the philosophy of any past or present supervisors and/or colleagues.
YusufSWittesJProbstfieldJTyrolerHA. Analysis and Interpretation of Treatment Effects in Subgroups of Patients in Randomized Clinical Trials. JAMA. 1991;266(1):93–98.
2.
PocockSJ. Clinical Trials: A Practical Approach. New York: Wiley and Sons; 1983.
3.
SimonR. Patient Subsets and Variation in Therapeutic Efficacy. Br J Clin Pharm.1982;14: 473–482.
4.
SimonR. Statistical Tools for Subset Analysis in Clinical Trials. In BaumM.HayR.SchuerleinH., eds. Recent Results in Cancer Research. Heidelberg, Germany: Springer-Verlag; 1988.
5.
BulpittCJ. Subgroup Analysis. The Lancet. 1988;July 2:31–34.
6.
SimonR. Design, Analysis, and Reporting of Cancer Clinical Trails. In PeaceK., ed. Biopharmaceutical Statistics for Drug Development. New York: Marcel Dekker; 1988.
7.
Guideline For the Format and Content of the Clinical and Statistical Sections of New Drug Applications. Rockville, MD: U.S. Food and Drug Administration, Dept of Health and Human Services; 1988.
