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OVERVIEW

Introduction
ClinicalTrials.gov: An Introduction to Clinical Trials
ClinicalTrials.gov: Links to General Information on Clinical Trials

Clinical Trials and Regulation
FDA: Clinical Trials
FDA: Good Clinical Practice (PDF)
FDA: Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions (PDF)
FDA: Guidance for Institutional Review Boards and Clinical Investigators

Clinical Trials and Payment
CMS: Medicare Coverage ~ Clinical Trials (PDF)

Journals
Clinical Trials
Contemporary Clinical Trials
Applied Clinical Trials

News on Clinical Trials
ClinicalTrials.gov: Clinical trial news

Societies
Society for Clinical Trials

METHODS

Introduction
ClinicalTrials.gov: Types of Clinical Trials
King's College: Cross-=sectional Studies, Cohort Studies, Risk Factors, Prognostic Factors

Glossary of Terms
ClinicalTrials.gov: Glossary of Clinical Trial Terms
ClinicalStudyResults.org: Glossary of Terms

Clinical Trial Design
FDA: Good Clinical Practice in FDA-Regulated Clinical Trials
FDA Guidance: Choice of Control Group and Related Issues in Clinical Trials (PDF)
CEBM: Study Design

Statistical Methods
MJA: Statistical methods in clinical trials (PDF)
BMJ: Statistics at Square One: study design and choosing a statistical test
FDA: Statistical Guidance for Clinical Trials of Non-Diagnostic Medical Devices

Interpretation of Results
FDA: Considerations on Strength and Consistency of Evidence

Clinical Practice Guidelines
AHRQ: Clinical Practice Guidelines Online

APPLICATIONS

Introduction

Clinical Trial Databases
ClinicalTrials.gov: Focused Clinical Trial Search
Clinical Trials.gov: Browse Trials by Disease Heading
ClinicalTrials.gov: Browse Trials Alphabetically
Centerwatch: Clinical Trials Listing Service

Clinical Trial Registration
Ottawa Statement on Clinical Trial Registration

Clinical Study Results
ClinicalStudyResults.org

Monitoring of Clinical Studies
FDA: Guide for the Monitoring of Clinical Invesitgations

Payment of Clinical Studies
CMS: Medicare Learning Network (Medlearn)
Clinical Trials and Medicare

CMS: Coverage Issues Manual
CMS: Medicare Coverage Routine Costs of Beneficiaries in Clinical Trials




last updated on 3/13/2007 at 12:58:06.0 PM by 171.65.102.151
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