Preface

Introduction

The use and importance of observational data—such as naturalistic real-world trials, patient registries, and health care claims database analyses—have grown in recent years. Observational research produces real-world data—information on how treatments or policies work in practice—that is critical to consumers interested in actual practice information. Such data are now commonly used by researchers and health care decision-makers to assess treatment strategies and make policy decisions. However, techniques and standards for statistical analysis are less well-developed for observational data compared with randomized clinical trials. Quality analyses of observational data are more challenging due to such issues as selection ...

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