LEADER 00000cam  2200793 a 4500 
001    795687253 
003    OCoLC 
005    20200814214257.1 
006    m     o  d         
007    cr |n||||||||| 
008    120615s2013    mdu     obf   001 0 eng   
010    2012024931 
020    9781118422823|q(pdf) 
020    1118422821|q(pdf) 
020    9781118422793|q(epub) 
020    1118422791|q(epub) 
020    9781118422847|q(mobi) 
020    1118422848|q(mobi) 
020    9781118422878|q(electronic bk.) 
020    1118422872|q(electronic bk.) 
020    |z9781118218464|q(hardback) 
020    1118218469 
020    9781118218464 
035    (OCoLC)795687253|z(OCoLC)1148101441 
035    Ebook Central DDA Titles 
035    skip4alma 
040    DLC|beng|epn|cDLC|dYDX|dN$T|dEBLCP|dUIU|dYDXCP|dDG1|dUBY
042    pcc 
049    txum 
050 00 RM301.27eb 
072  7 MED|x023000|2bisacsh 
072  7 MED|x058170|2bisacsh 
072  7 MED|x071000|2bisacsh 
072  7 MED|x072000|2bisacsh 
100 1  Meinert, Curtis L. 
245 10 Clinical trials handbook :|bdesign and conduct /|cCurtis 
       L. Meinert. 
260    Baltimore, MD :|bWiley,|c©2013. 
300    1 online resource 
336    text|btxt|2rdacontent 
337    computer|bc|2rdamedia 
338    online resource|bcr|2rdacarrier 
500    "Written by an eminent epidemiologist and clinician, this 
       comprehensive book outlines and categorizes the required 
       methodological steps employed in the clinical trial 
       evaluation process. The author appropriately mixes the 
       scientific, logistical, ethical, psychological, behavioral,
       and administrative issues inherent in the field, while 
       also emphasizing conduct, performance, and protocol. With 
       questions posed to pique reader interest; concepts readily
       available through an organizational hierarchy; and 
       PowerPoint slide suggestions showcased throughout, this is
       a must-have book for all practicing clinicians and 
       teachers of clinical trials courses"--Provided by 
500    Machine generated contents note: Preface xiOn planning 
       xiiiExplanatory notes, focus, and conventions xvI. General
       31. Terminology 42. Definitions 63. Measurement units 84. 
       Trial type 95. Design and flow schematics 126. Design and 
       operating principles 137. Counting and analysis rules 148.
       Multi-study umbrella name 169. Study name 18II. Design 
       specifications 2110. Objective 2211. Specific aims 2412. 
       Experimental variable 2513. Treatment unit 2614. Primary 
       outcome 2815. Outcome measures 3116. Design synopsis 
       33III. Funding 3717. Type of funding initiative 3818. 
       Funding: Specifications 4019. Funding: Terminology 4220. 
       Funding: Type 5021. Funding: Initiative 5122. Funding: 
       Period 5323. Funding: Budget 5424. Funding: Mode 56IV. 
       Treatment groups/treatment administration 5925. Study 
       groups 6026. Comparison group 6227. Study treatments 6428.
       Test treatments 6629. Control/comparison treatment 6830. 
       Placebo treatment 7531. Sham treatment 8032. Treatment 
       modality 8233. Treatment schedule 8334. Treatment 
       compliance measures 8535. Protocol overrides 8836. 
       Protocol bailouts 90V. Masking 9337. Mask/masking: 
       Definitions 9438. Masking principles 9739. Masking, 
       censoring, and shielding specifications 9940. Drug masking
       procedure 10141. Drug packaging and labeling 10342. Drug 
       supply 10643. Masking safeguards 10844. Unmasking 
       treatment assignment 10945. Results blackouts 110VI. Bias 
       and variance control 11346. Bias control procedures 11447.
       Stratification 11748. Variance control procedures 12049. 
       Separations 122VII. Treatment assignment/randomization 
       12350. Assignment methods: Fixed vs adaptive 12451. 
       Treatment assignment: Random vs nonrandom 12652. 
       Randomization: Complete vs restricted 12953. Randomization
       unit 13254. Randomization: Procedures 134VIII. IRBs and 
       consents 13555. IRBs 13656. IRBs: Models and procedures 
       13857. Consent 14358. Consent: Checklist 15059. Consent: 
       Disclaimers and notifications 15360. Consent: Principles 
       and purpose 15561. Consent: Process 15762. Consent: Types 
       16063. Consent: Questions and answers 162IX. Enrollment 
       and followup 16764. Notation 16865. Timing conventions 
       17166. Required approvals, permissions, accesses, and 
       supplies 17367. Start-up design 17568. Start-up checklist 
       17969. Recruitment design 18070. Enrollment goals 18271. 
       Enrollment quotas 18472. Followup: Terminology 18973. 
       Followup: Method 19374. Followup: Length 19575. Closeout 
       design 19676. Missed visit 19977. Dropout 20078. Loss to 
       followup 20479. Study timetable 20780. Critical event path
       analysis 20981. Eligibility criteria 21282. Exclusions 
       from enrollment 21583. Eligibility and exclusions by 
       reason 219X. Sample size 22184. Sample size: Design 22285.
       Sample size: Specifications 22686. Sample size: 
       Calculation 22987. Fixed versus sequential sample size 
       designs 23188. Fixed versus adaptive designs 23389. 
       Designed subgroup comparisons 235XI. Data collection and 
       processing 23990. Contact schedule 24091. Examinations/
       visits 24192. Examination/clinic visit schedule 24593. 
       Data collection 24994. Data collection: Schedules and 
       procedures 25295. Data flow 25596. Data processing 
       procedures 25797. Laboratory tests 26098. Readings 26299. 
       Tissue repositories 266100. Form design: Principles and 
       procedures 268101. Time window specifications 272102. Data
       entry design 274103. Data sharing: Internal 280104. Data 
       sharing: External 283XII. Study centers 287105. Center 
       types 288106. Centers 291107. Center requirements 293XIII.
       Investigators/study staff 297108. Investigator 
       requirements 298109. Clinic staffing requirements 300110. 
       Research group/Investigators 302XIV. Committees 305111. 
       Key committees 306112. Standing and working committees 
       307113. Committee rules and procedures 308114. Study 
       officers 312115. Study chair/vice-chair 313116. Executive 
       committee 317117. Executive committee members 319118. 
       Steering committee 320119. Steering committee members 
       322120. Steering committee: Questions, answers, and 
       observations 324121. Steering committee representation 
       models 327XV. Treatment effects monitoring 331122. 
       Treatment effects monitoring 332123. Treatment effects 
       monitoring: Purpose 334124. Treatment effects monitoring: 
       Approach 336125. Treatment effects monitoring: Masking 
       338126. Stopping rules and guidelines 340127. Treatment 
       effects monitoring: Questions and answers 342128. 
       Treatment effects monitoring committee 345129. Treatment 
       effects monitoring committee: Questions and answers 
       347XVI. Quality control and assurance 351130. Quality 
       control and assurance procedures 352131. Performance 
       monitoring 356132. Training procedures 358133. Assurances 
       and certifications 359134. Site visiting procedures 
       361135. Audit procedures 364XVII. Data analysis 367136. 
       Analysis datasets 368137. Analysis questions regarding 
       study results publications 370138. Frequentist vs Bayesian
       analysis 372139. Final analysis 374140. Subgroup analysis 
       376XVIII. Publication/presentation 379141. Publication 
       380142. Publication policy 382143. Authorship 384144. 
       Credits 389145. Presentation policy 393XIX. Policies 
       395146. Policies 396147. Publicity policy 397148. Policy 
       on access to study documents 398149. Policy on access to 
       study data and results 400150. Policy on advertising for 
       patients 403151. Policy on incentive payments 404152. 
       Policy on payment of patient related travel expenses 
       406153. Ancillary study policy 407154. Policy on patient 
       care related payments 409155. Policy on conflicts of 
       interest 410156. Substudy policy 413XX. Adverse events 
       415157. Adverse events 416158. Adverse event reporting 
       procedures 420XXI. Miscellaneous 423159. Key study 
       documents 424160. Design synopsis 425161. Slide sets 
       426162. Study CV 427163. Study website 428164. Study 
       history log 429165. Landmark events and dates 431166. 
       Registration 433Appendices 435Appendix 1. Design summaries
       437Appendix 2. Sample design slide sets 457Appendix 3. 
       Template worksheets and slides 489References 505Index 516.
504    Includes bibliographical references and index. 
505 00 |gI.|tGeneral --|g1.|tTerminology --|g2.|tDefinitions --
       |g3.|tMeasurement units --|g4.|tTrial type --|g5.|tDesign 
       and flow schematics --|g6.|tDesign and operating 
       principles --|g7.|tCounting and analysis rules --|g8.
       |tMulti-study umbrella name --|g9.|tStudy name --|gII.
       |tDesign Specifications --|g10.|tObjective --|g11.
       |tSpecific aims --|g12.|tExperimental variable --|g13.
       |tTreatment unit --|g14.|tPrimary outcome --|g15.|tOutcome
       measures --|g16.|tDesign synopsis --|gIII.|tFunding --
       |g17.|tType of funding initiative --|g18.|tFunding: 
       Specifications --|g19.|tFunding: Terminology --|g20.
       |tFunding: Type --|g21.|tFunding: Initiative --|g22.
       |tFunding: Period --|g23.|tFunding: Budget --|g24.
       |tFunding: Mode --|gIV.|tTreatment Groups/Treatment 
       Administration --|g25.|tStudy groups --|g26.|tComparison 
       group --|g27.|tStudy treatments --|g28.|tTest treatments -
       -|g29.|tControl/comparison treatment --|g30.|tPlacebo 
       treatment --|g31.|tSham treatment --|g32.|tTreatment 
       modality --|g33.|tTreatment schedule --|g34.|tTreatment 
       compliance measures --|g35.|tProtocol overrides --|g36.
       |tProtocol bailouts --|gV.|tMasking --|g37.|tMask/masking:
       Definitions --|g38.|tMasking principles --|g39.|tMasking, 
       censoring, and shielding specifications --|g40.|tDrug 
       masking procedure --|g41.|tDrug packaging and labeling --
       |g42.|tDrug supply --|g43.|tMasking safeguards --|g44.
       |tUnmasking treatment assignment --|g45.|tResults 
       blackouts --|gVI.|tBias and Variance Control --|g46.|tBias
       control procedures --|g47.|tStratification --|g48.
       |tVariance control procedures --|g49.|tSeparations --
       |gVII.|tTreatment Assignment/Randomization --|g50.
       |tAssignment methods: Fixed vs. adaptive --|g51.
       |tTreatment assignment: Random vs. nonrandom --|g52.
       |tRandomization: Complete vs. restricted --|g53.
       |tRandomization unit --|g54.|tRandomization: Procedures --
       |gVIII.|tIRBs and Consents --|g55.|tIRBs --|g56.|tIRBs: 
       Models and procedures --|g57.|tConsent --|g58.|tConsent: 
       Checklist --|g59.|tConsent: Disclaimers and notifications 
       --|g60.|tConsent: Principles and purpose --|g61.|tConsent:
       Process --|g62.|tConsent: Types --|g63.|tConsent: 
       Questions and answers --|gIX.|tEnrollment and Followup --
       |g64.|tNotation --|g65.|tTiming conventions --|g66.
       |tRequired approvals, permissions, accesses, and supplies 
       --|g67.|tStart-up design --|g68.|tStart-up checklist --
       |g69.|tRecruitment design --|g70.|tEnrollment goals --
       |g71.|tEnrollment quotas --|g72.|tFollowup: Terminology --
       |g73.|tFollowup: Method --|g74.|tFollowup: Length --|g75.
       |tCloseout design --|g76.|tMissed visit --|g77.|tDropout -
       -|g78.|tLoss to followup --|g79.|tStudy timetable --|g80.
       |tCritical event path analysis --|g81.|tEligibility 
       criteria --|g82.|tExclusions from enrollment --|g83.
       |tEligibility and exclusions by reason --|gX.|tSample Size
       --|g84.|tSample size: Design --|g85.|tSample size: 
       Specifications --|g86.|tSample size: Calculation --|g87.
       |tFixed vs. sequential sample size designs --|g88.|tFixed 
       vs. adaptive designs --|g89.|tDesigned subgroup 
       comparisons --|gXI.|tData Collection and Processing --
       |g90.|tContact schedule --|g91.|tExaminations/visits --
       |g92.|tExamination/clinic visit schedule --|g93.|tData 
       collection --|g94.|tData collection: Schedules and 
       procedures --|g95.|tData flow --|g96.|tData processing 
       procedures --|g97.|tLaboratory tests --|g98.|tReadings --
       |g99.|tTissue repositories --|g100.|tForm design: 
       Principles and procedures --|g101.|tTime window 
       specifications --|g102.|tData entry design --|g103.|tData 
       sharing: Internal --|g104.|tData sharing: External --
       |gXII.|tStudy Centers --|g105.|tCenter types --|g106.
       |tCenters --|g107.|tCenter requirements --|gXIII.
       |tInvestigators/Study Staff --|g108.|tInvestigator 
       requirements --|g109.|tClinic staffing requirements --
       |g110.|tResearch group/Investigators --|gXIV.|tCommittees 
       --|g111.|tKey Committees --|g112.|tStanding and working 
       committees --|g113.|tCommittee rules and procedures --
       |g114.|tStudy officers --|g115.|tStudy chair/vice-chair --
       |g116.|tExecutive committee --|g117.|tExecutive committee 
       members --|g118.|tSteering committee --|g119.|tSteering 
       committee members --|g120.|tSteering committee: Questions,
       answers, and observations --|g121.|tSteering committee 
       representation models --|gXV.|tTreatment Effects 
       Monitoring --|g122.|tTreatment effects monitoring --|g123.
       |tTreatment effects monitoring: Purpose --|g124.
       |tTreatment effects monitoring: Approach --|g125.
       |tTreatment effects monitoring: Masking --|g126.|tStopping
       rules and guidelines --|g127.|tTreatment effects 
       monitoring: Questions and answers --|g128.|tTreatment 
       effects monitoring committee --|g129.|tTreatment effects 
       monitoring committee: Questions and answers --|gXVI.
       |tQuality Control and Assurance --|g130.|tQuality control 
       and assurance procedures --|g131.|tPerformance monitoring 
       --|g132.|tTraining procedures --|g133.|tAssurances and 
       certifications --|g134.|tSite visiting procedures --|g135.
       |tAudit procedures --|gXVII.|tData Analysis --|g136.
       |tAnalysis datasets --|g137.|tAnalysis questions regarding
       study results publications --|g138.|tFrequentist vs. 
       Bayesian analysis --|g139.|tFinal analysis --|g140.
       |tSubgroup analysis --|gXVIII.|tPublication/Presentation -
       -|g141.|tPublication --|g142.|tPublication policy --|g143.
       |tAuthorship --|g144.|tCredits --|g145.|tPresentation 
       policy --|gXIX.|tPolicies --|g146.|tPolicies --|g147.
       |tPublicity policy --|g148.|tPolicy on access to study 
       documents --|g149.|tPolicy on access to study data and 
       results --|g150.|tPolicy on advertising for patients --
       |g151.|tPolicy on incentive payments --|g152.|tPolicy on 
       payment of patient-related travel expenses --|g153.
       |tAncillary study policy --|g154.|tPolicy on patient-care-
       related payments --|g155.|tPolicy on conflicts of interest
       --|g156.|tSubstudy policy --|gXX.|tAdverse Events --|g157.
       |tAdverse events --|g158.|tAdverse event reporting 
       procedures --|gXXI.|tMiscellaneous --|g159.|tKey study 
       documents --|g160.|tDesign synopsis --|g161.|tSlide sets -
       -|g162.|tStudy CV --|g163.|tStudy website --|g164.|tStudy 
       history log --|g165.|tLandmark events and dates --|g166.
506    Available only to authorized UTEP users. 
588 0  Print version record and CIP data provided by publisher. 
650  0 Drugs|xTesting|vHandbooks, manuals, etc. 
650  0 Clinical trials|vHandbooks, manuals, etc. 
650 12 Clinical Trials 
650 22 Drug Evaluation|xmethods. 
650 22 Meta-Analysis 
655  7 Handbooks and manuals.|2fast|0(OCoLC)fst01423877 
776 08 |iPrint version:|aMeinert, Curtis L.|tClinical trials 
       handbook.|dBaltimore, MD : Wiley, ©2013|z9781118218464
       |w(DLC)  2012015097 
856 40 |uhttp://0-ebookcentral.proquest.com.lib.utep.edu/lib/utep
       /detail.action?docID=918276|zTo access this resource 
880    |6520-00/Hani|a"A systematic approach to all aspects of 
       designing and conducting clinical trials The success or 
       failure of clinical trials hinges on hundreds of details 
       that need to be developed, often under less than ideal 
       conditions. Written by one of the world''s leading 
       trialists, Clinical Trials Handbook: Design and Conduct 
       provides clinicians with a complete guide to designing, 
       conducting, and evaluating clinical trials䥡ching 
       them how to simplify the process and avoid costly 
       mistakes. The author draws on his extensive clinical 
       trials experience to outline all steps employed in setting
       up and running clinical trials, from budgeting and 
       fundraising to publishing the results. Along the way, 
       practical advice is offered while also addressing a mix of
       logistical, ethical, psychological, behavioral, and 
       administrative issues inherent to clinical trials. Topics 
       of coverage include: Protocols for drug masking, controls,
       and treatment randomization Consent, enrollment, 
       eligibility, and follow-up procedures Different types of 
       sample size design and data collection and processing 
       Working with study centers, research staff, and various 
       committees Monitoring treatment effects and performance, 
       and ensuring quality control Data analysis and access 
       policies for study data and documents Clinical Trials 
       Handbook is invaluable for practicing clinicians and 
       trialists who would like to learn more about or improve 
       their understanding of the design and execution of 
       clinical trials. The book is also an excellent supplement 
       for courses on clinical trials at the graduate level"--
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