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Cancer Clinical Trials: Proactive Strategies
von: Stanley P. L. Leong
Springer-Verlag, 2007
ISBN: 9780387332253 , 320 Seiten
Format: PDF
Kopierschutz: Wasserzeichen
Preis: 149,79 EUR
CONTENTS
6
CONTRIBUTORS
8
FOREWORD
13
PREFACE
16
ACKNOWLEDGEMENT
17
HISTORICAL PERSPECTIVE AND EVOLVING CONCERNS FOR HUMAN RESEARCH
18
CANCER TRIALS AND THE INSTITUTIONAL REVIEW BOARD ( IRB)
28
NCI'S CANCER THERAPY EVALUATION PROGRAM: A COMMITMENT TO TREATMENT TRIALS
48
THE ROLE OF THE FDA IN CANCER CLINICAL TRIALS
68
THE ROLE OF COOPERATIVE GROUPS IN CANCER CLINICAL TRIALS
127
THE ADVOCATE ROLE IN CLINICAL STUDY DEVELOPMENT AND PARTNERING WITH PATIENT ADVOCATES IN YOUR LOCAL INSTITUTION
146
THE NATIONAL BREAST CANCER COALITION: SETTING THE STANDARD FOR ADVOCATE COLLABORATION IN CLINICAL TRIALS
157
THE ROLE OF THE PRINCIPAL INVESTIGATOR IN CANCER CLINICAL TRIALS
171
THE AUDIT PROCESS AND HOW TO ENSURE SUCCESSFUL AUDIT
192
THE PRIVACY RULE (HIPAA) AS IT RELATES TO CLINICAL RESEARCH
211
THE COMMISSION ON CANCER, AMERICAN COLLEGE OF SURGEONS' RESPONSE TO HIPAA
220
ETHICAL AND LEGAL ISSUES IN THE CONDUCT OF CANCER CLINICAL TRIALS
229
THE ROLE OF THE OFFICE OF RESEARCH INTEGRITY IN CANCER CLINICAL TRIALS
240
STRATEGIES FOR THE ADMINISTRATION OF A CLINICAL TRIALS INFRASTRUCTURE: LESSONS FROM A COMPREHENSIVE CANCER CENTER
249
THE CLINICAL RESEARCH PROCESS: BUILDING A SYSTEM IN HARMONY WITH ITS USERS
283
CANCER RESEARCH AND CLINICAL TRIAL IN ACTION: AN IMPORTANT EXERCISE BEFORE YOU EMBARK ON YOUR STUDY
299
INDEX
318
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