Translational Orthopedics

ISBN-13: 9780323856638 / Miękka / 2024 / 450 str.

Spis treści

PART I: PRE-CLINICAL: DISCOVERY & DEVELOPMENT 1 Defining the problem to solve 2 Types of problems 3 Drug discovery 4 Device discovery 5 Device classification 6 Other product types 7 Drug safety 8 Device prototyping 9 Device testing PART II: CLINICAL: FUNDAMENTALS 10 Introduction to clinical research 11 The question 12 Study population 13 Outcome measurements 14 Presenting data 15 Common issues in analysis 16 Basic statistical principles 17 Distributions 18 Hypotheses and error types 19 Power 20 Regression 21 Continuous variable analyses 22 Categorical variable analyses 23 Analysis of variance 24 Correlation 25 Biases 26 Basic science statistics 27 Sample forms and templates PART III: CLINICAL: STUDY TYPES 28 Design principles 29 Case series 30 Case-control study 31 Cohort study 32 Cross-section study 33 Clinical trials 34 Meta-analysis 35 Cost effectiveness study 36 Diagnostic test evaluation 37 Reliability study 38 Database studies 39 Surveys and questionnaires 40 Qualitative methods and mixed methods PART IV: CLINICAL TRIALS 41 Randomized control 42 Nonrandomized control 43 Historical control 44 Cross-over 45 Withdrawal studies 46 Factorial design 47 Group allocation 48 Hybrid design 49 Large, pragmatic 50 Equivalence and noninferiority 51 Adaptive 52 Randomization 53 Blinding 54 Multicenter considerations 55 Registries - added chapter per reviewer suggestion PART V: CLINICAL: PREPARATION 56 Optimizing the question 57 Meaningful outcome 58 Sample size 59 Budgeting 60 Ethics and review boards 61 Regulatory considerations for new drugs and devices 62 Funding approaches 63 Subject recruitment 64 Data management 65 Quality control 66 Report forms 67 Subject adherence 68 Survival analysis 69 Monitoring committee in clinical trials PART VI: REGULATORY 70 FDA Overview 71 New drug application 72 Device pathways 73 Non-US regulatory 74 Post-market drug safety monitoring 75 Post-market device safety monitoring APPENDIX 76 Patent basics 77 Venture pathways