Small Clinical Trials: Issues and Challenges Book

	Executive Summary	1
1	Introduction	12
	When the Standard Approach to Clinical Trials Is Not Feasible	13
	A Search for Alternative	15
	IOM Committee Process and Statement of Task	18
	Organization of the Report	19
2	Design of Small Clinical Trials	20
	Key Concepts in Clinical Trial Design	21
	Traditional Clinical Trial Designs	37
	Special Design Issues for Small Trials	41
3	Statistical Approaches to Analysis of Small Clinical Trials	60
	Sequential Analysis	61
	Hierarchical Models	67
	Bayesian Analysis	71
	Decision Analysis	73
	Statistical Prediction	77
	Meta-Analysis: Synthesis of Results of Independent Studies	80
4	General Guidelines	91
	References	94
	App. A: Study Methods	105
	App. B: Glossary of Statistical and Clinical Trials Terms	130
	App. C: Selected Bibliography on Small Clinical Trials	177
	App. D: Committee and Staff Biographies	201