LEADER 05386nam 2200661Ia 450 001 9910829980403321 005 20230607213139.0 010 $a1-280-26999-5 010 $a9786610269990 010 $a0-470-32228-4 010 $a0-470-85415-4 010 $a0-470-85416-2 035 $a(CKB)111056485598020 035 $a(EBL)139831 035 $a(OCoLC)53879180 035 $a(SSID)ssj0000135040 035 $a(PQKBManifestationID)11148982 035 $a(PQKBTitleCode)TC0000135040 035 $a(PQKBWorkID)10058408 035 $a(PQKB)10124994 035 $a(MiAaPQ)EBC139831 035 $a(EXLCZ)99111056485598020 100 $a20020711d2002 uy 0 101 0 $aeng 181 $ctxt 182 $cc 183 $acr 200 10$aData monitoring committees in clinical trials$b[electronic resource] $ea practical perspective /$fSusan S. Ellenberg, Thomas R. Fleming, David L. DeMets 210 $aChichester ;$aHoboken, NJ $cWiley$dc2002 215 $a1 online resource (209 p.) 225 1 $aStatistics in practice 300 $aDescription based upon print version of record. 311 0 $a0-471-48986-7 320 $aIncludes bibliographical references and index. 327 $aData Monitoring Committees in Clinical Trials A Practical Perspective; Contents; Preface; 1 Introduction; 1.1 Motivation; 1.2 History of data monitoring committees in government-sponsored trials; 1.3 Data monitoring committees in trials sponsored by the pharmaceutical industry; 1.4 Statistical methods for interim monitoring; 1.5 When are data monitoring committees needed?; 1.6 Where we are today; 1.7 Fundamental principles of data monitoring; References; 2 Responsibilities of the data monitoring committee and motivating illustrations; 2.1 Fundamental charges 327 $a2.2 Specific tasks of the data monitoring committee 2.2.1 Initial review; 2.2.1.1 Review of the study protocol; 2.2.1.2 Review of procedures to ensure quality of study conduct; 2.2.2 Evaluating the quality of ongoing study conduct; 2.2.3 Assessing safety and efficacy data; 2.2.3.1 Termination due to favorable benefit-to-risk; 2.2.3.2 Termination due to unfavorable benefit-to-risk; 2.2.3.3 Termination due to inability to answer trial questions; 2.2.3.4 Continuation of ongoing clinical trials; 2.2.3.5 Consideration of the overall picture: primary and secondary analyses 327 $a2.2.3.6 Modifying sample sizes based on ongoing assessment of event rates 2.2.4 Reviewing the final results; 2.3 The data monitoring committee charter; References; 3 Composition of a data monitoring committee; 3.1 Introduction; 3.2 Required areas of expertise; 3.3 Other relevant characteristics of committee members; 3.4 Committee size; 3.5 Selecting the committee chair; 3.6 Responsibility for appointing committee members; 3.7 Representation of other study components on the committee; 3.8 Preparation for service on a committee; References 327 $a4 Independence of the data monitoring committee: avoiding conflicts of interest 4.1 Introduction; 4.2 Rationale for independence; 4.3 Financial independence; 4.3.1 Sponsors; 4.3.2 Academic investigators; 4.4 Intellectual independence; 4.5 Emotional conflicts; 4.6 Individuals without conflicts; References; 5 Confidentiality issues relating to the data monitoring committee; 5.1 Rationale; 5.2 Limits of confidentiality; 5.2.1 Interim analysis reports; 5.2.2 Access to aggregate data on efficacy and safety outcomes; 5.2.3 The steering committee and maintaining confidentiality 327 $a5.2.4 Settings and procedures allowing broader unblinding 5.2.5 Some illustrations of broader unblinding; 5.2.6 Indirect challenges to confidentiality; 5.3 The need for the data monitoring committee to review unblinded data; References; 6 Data monitoring committee meetings; 6.1 Introduction; 6.2 Specific objectives and timing of meetings; 6.2.1 Organizational meeting; 6.2.2 Early safety/trial integrity reviews; 6.2.3 Formal interim efficacy analyses; 6.2.4 End-of-trial debriefing; 6.3 Preparation of meeting reports; 6.4 Format for meetings; 6.4.1 The closed session; 6.4.2 The open session 327 $a6.4.3 The final closed session 330 $aThere has been substantial growth in the use of data monitoring committees in recent years, by both government agencies and the pharmaceutical industry. This growth has been brought about by increasing recognition of the value of such committees in safeguarding trial participants as well as protecting trial integrity and the validity of conclusions. This very timely book describes the operation of data monitoring committees, and provides an authoritative guide to their establishment, purpose and responsibilities.* Provides a practical overview of data monitoring in clinical trials.* 410 0$aStatistics in practice. 606 $aClinical trials 606 $aMedical ethics committees 615 0$aClinical trials. 615 0$aMedical ethics committees. 676 $a610/.72/4 676 $a615.190072 700 $aEllenberg$b Susan Smith$01657793 701 $aFleming$b Thomas R$0103526 701 $aDeMets$b David L.$f1944-$01659683 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910829980403321 996 $aData monitoring committees in clinical trials$94014446 997 $aUNINA