Clinical Research in Oral Health

Clinical Research in Oral Health......Page 5
Contents......Page 9
Contributors......Page 15
Preface......Page 19
Acknowledgments......Page 21
1 Clinical and translational research: implications in the promotion of oral health......Page 25
1.1 Challenges to the translation of clinical research to clinical practice......Page 27
1.2 Health technology assessments—identifying research priorities for oral health research......Page 30
1.3 Comparative-effectiveness research (CER)......Page 31
2.1 Introduction......Page 35
2.2 Ethical foundations......Page 36
2.3 Is it human subjects research?......Page 38
2.4 Federal regulations......Page 39
2.5 The Institutional and Ethical Review Board (IRB) for studies related to oral health......Page 40
2.6 Informed consent......Page 49
2.7 Vulnerable populations......Page 52
2.9 Oral health clinical research......Page 55
2.10 Conclusion......Page 57
3 Responsibilities of institutions and individuals in clinical research in the oral health sciences......Page 59
3.1 Governmental and institutional regulations, policies, and guidelines......Page 60
3.2 Educational responsibilities of institutions......Page 63
3.3 Financial responsibilities of institutions......Page 65
3.4 Responsibilities of investigators for FDA-regulated clinical research......Page 66
3.5 Intellectual property and clinical research......Page 67
3.6 Authorship......Page 68
3.7 Scientific misconduct......Page 70
3.8 Conflicts of interest (COI)......Page 72
3.9 Concluding remarks......Page 73
4 Regulatory process for the evaluation of dental drugs, devices, and biologics......Page 77
4.1 Mission of FDA......Page 78
4.3 Different pathways to approval......Page 80
4.4 Approved and nonapproved dental-related products......Page 95
4.5 Regulatory processes in Canada, Europe, and other countries......Page 97
4.6 Summary......Page 98
5.1 Introduction and chapter overview......Page 101
5.2 Funding sources and opportunities......Page 102
5.3 Grant-writing basics and developing research proposals......Page 110
5.4 Oversight of funded clinical research......Page 120
5.5 Conclusion......Page 121
6.1 Introduction......Page 125
6.2 Developing a data management plan......Page 126
6.3 Defining variables......Page 127
6.4 Preparing the database for data entry......Page 133
6.5 Using the database for data collection......Page 136
6.6 Using the data for analyses......Page 143
7.1 Introduction......Page 145
7.2 How can hypothesis testing lead to an overabundance of false-positive leads?......Page 146
7.3 Quantifying the false-positive rates; the theory......Page 148
7.4 Minimizing false-positive conclusions;  , registries, surrogates, randomization......Page 152
7.5 Conclusion......Page 155
8.1 Introduction......Page 159
8.2 Classification of outcomes......Page 160
8.3 Measurements of outcomes......Page 162
8.4 Dental and oral health outcomes in clinical research......Page 169
8.5 Outcomes and causal pathways......Page 174
8.6 Final comments......Page 175
9.1 Rationale......Page 181
9.3 Components of assessment......Page 182
9.4 Bleeding on probing......Page 184
9.5 Probing pressure and probe angulation......Page 185
9.6 Patterns of examiner bias......Page 187
9.7 Subjects for examiner training......Page 188
9.8 Standardization versus calibration......Page 189
9.10 Intra-examiner variability......Page 190
9.12 Needs for reporting......Page 193
10.1 Introduction......Page 199
10.2 Rationale and value of observational studies......Page 200
10.3 Concepts, principles, and methods......Page 201
10.4 Types of observational study designs......Page 207
10.5 Final comments......Page 217
11.1 Introduction......Page 221
11.2 Phase 1 clinical trials—drugs......Page 222
11.3 Medical devices—pilot and prepivotal studies......Page 225
11.4 Phase 2 clinical trials—drugs......Page 226
11.5 Sample study designs......Page 229
11.6 Summary and conclusion......Page 233
12 Phase III pivotal clinical trials: clinical decision making......Page 235
12.1 Where do phase III trials fit into the grand scheme?......Page 236
12.2 Clinical trial or not: a decision-making overview......Page 237
12.3 Clinical trials and their phases......Page 239
12.4 Phase III trials: organizational complexity......Page 241
12.5 Key elements of a phase III clinical trial......Page 244
12.6 Recruitment and retention of participants in phase III trials......Page 260
12.7 Oversight of the phase III trial: shared responsibilities......Page 262
12.8 Concluding comment......Page 265
13.2 Definitions......Page 269
13.4 Burden......Page 270
13.5 Need for pharmacoepidemiology and pharmacosurveillance: how a drug or class III medical device is approved for use (premarket)......Page 272
13.6 History......Page 273
13.7 Legislation and regulations in the United States......Page 274
13.8 Monitoring ADE after drug approval......Page 276
13.9 Monitoring medical devices......Page 280
13.11 International issues......Page 281
13.12 Future challenges......Page 282
14.1 Introduction to dental practice-based research networks (PBRN)......Page 287
14.2 Network infrastructure development and governance including fiscal issues......Page 288
14.3 Practice-based research in large group dental practices......Page 290
14.4 Recruitment and retention strategies for practice-based research network investigators......Page 291
14.5 Study idea acquisition, prioritization, and development......Page 294
14.6 Study deployment, implementation, and coordination......Page 298
14.7 Data acquisition and analysis......Page 303
14.8 Participant protection and scientific peer review in dental PBRN......Page 305
14.9 Translation of research into practice......Page 310
15.1 Introduction......Page 317
15.2 The technology transfer premise......Page 319
15.3 The technology transfer process in academic institutions......Page 321
15.4 What is the role of the scientist in the process of technology transfer?......Page 322
15.5 The role of the technology transfer officer at academic institutions......Page 323
15.6 University start-up companies......Page 324
15.7 Licensing to existing companies......Page 325
15.8 Innovations in dentistry......Page 326
16.1 The problem?......Page 327
16.2 The scurvy problem......Page 328
16.3 Why the failure to adopt?......Page 329
16.5 A current example......Page 330
16.8 Persuasion to adopt......Page 331
16.9 Deciding......Page 332
16.11 Reinvention......Page 333
16.13 Adoption and current practices......Page 334
16.15 Dental sealants......Page 335
16.16 Periodontal maintenance......Page 337
16.17 Implant adoption......Page 338
16.18 Concluding remarks......Page 341
17.1 Planning for publication......Page 343
17.2 Selecting a target journal......Page 347
17.3 Writing the draft manuscript......Page 350
17.4 Manuscript submission and revision......Page 358
18 The evidence base for oral health......Page 363
18.1 The Cochrane Collaboration......Page 365
18.2 The Cochrane Oral Health Group......Page 366
18.3 Statistical methods......Page 369
18.4 COHG reviews......Page 371
18.5 Non-RCT reviews......Page 372
18.6 Summary......Page 374
Index......Page 379