Clinical Trials

More documents

Recommendations

Info

❘❙❚■ Chapter 13 | Bioequivalence <strong>Trials</strong>5. Hauck WW, Anderson S. A new statistical procedure for testing equivalence in two-groupcomparative bioavailability trials. J Pharmacokinet Biopharm 1984;12:83–91.6. Schuirmann DJ. A comparison of the two one-sided tests procedure and the power approach forassessing the equivalence of average bioavailability. J Pharmacokinet Biopharm 1987;15:657–80.7. Westlake WJ. Statistical aspects of comparative bioavailability trials. Biometrics 1979;35:273–80.130
■■❚❙❘Chapter 14Noninferiority <strong>Trials</strong>Sam Miller, Colin Neate, and Duolao WangA noninferiority trial aims to demonstrate that the effect of anew treatment is as good as, or better than, that of an activecomparator. This is assessed by demonstrating that the newtreatment is not worse than the comparator by more than aspecified margin (the noninferiority margin [δ]). In this chapter,we discuss in detail, using a recent trial, situations wherenoninferiority trials are appropriate, factors to be consideredwhen choosing an appropriate δ, methods for sample sizedetermination, and the issues involved in the analysis andevaluation of noninferiority.131
Page 8:
❘❙❚■ ContributorsStephen L
Page 11 and 12:
Clinical Trials: A Practical Guide
Page 13 and 14:
Page 15:
Page 19 and 20:
■■❚❙❘Chapter 1RandomizedC
Page 21 and 22:
Page 23 and 24:
Page 25 and 26:
Page 27 and 28:
Page 29 and 30:
Page 31:
Page 34 and 35:
❘❙❚■ Chapter 2 | Uncontroll
Page 36 and 37:
Page 38 and 39:
Page 41 and 42:
■■❚❙❘Chapter 3Protocol De
Page 43 and 44:
Page 45 and 46:
Page 47 and 48:
Page 49 and 50:
Page 51 and 52:
Page 53 and 54:
Page 55 and 56:
■■❚❙❘Chapter 4EndpointsAm
Page 57 and 58:
Page 59 and 60:
Page 61 and 62:
Page 63 and 64:
Page 65 and 66:
■■❚❙❘Chapter 5Patient Sel
Page 67 and 68:
Page 69 and 70:
Page 71 and 72:
Page 73 and 74:
■■❚❙❘Chapter 6Source and
Page 75 and 76:
Page 77 and 78:
Page 79 and 80:
Page 81 and 82:
Page 83 and 84:
■■❚❙❘Chapter 7Randomizati
Page 85 and 86:
Page 87 and 88:
Page 89 and 90:
Page 91:
Page 94 and 95:
❘❙❚■ Chapter 8 | BlindingBl
Page 96 and 97:
❘❙❚■ Chapter 8 | BlindingTh
Page 98 and 99: ❘❙❚■ Chapter 8 | BlindingAs
Page 100 and 101: ❘❙❚■ Chapter 9 | Sample Siz
Page 107: ■■❚❙❘Part IIAlternativeTr
Page 110 and 111: ❘❙❚■ Chapter 10 | Crossover
Page 118 and 119: 100
Page 120 and 121: ❘❙❚■ Chapter 11 | Factorial
Page 132 and 133: ❘❙❚■ Chapter 12 | Equivalen
Page 138 and 139: ❘❙❚■ Chapter 13 | Bioequiva
Page 150 and 151: ❘❙❚■ Chapter 14 | Noninferi
Page 160 and 161: ❘❙❚■ Chapter 15 | Cluster R
Page 170 and 171: 152
Page 172 and 173: ❘❙❚■ Chapter 16 | Multicent
Page 183 and 184: ■■❚❙❘Part IIIBasics ofSta
Page 185 and 186: ■■❚❙❘Chapter 17Types of D
Page 187 and 188: Clinical Trials: A Practical Guide
Page 199 and 200:
Page 201 and 202:
Page 203 and 204:
■■❚❙❘Chapter 18Significan
Page 205 and 206:
Page 207 and 208:
Page 209 and 210:
Page 211 and 212:
Page 213 and 214:
Page 215 and 216:
■■❚❙❘Chapter 19Comparison
Page 217 and 218:
Page 219 and 220:
Page 221 and 222:
Page 223 and 224:
Page 225 and 226:
Page 227 and 228:
Page 229 and 230:
Page 231 and 232:
Page 233 and 234:
Page 235 and 236:
■■❚❙❘Chapter 20Comparison
Page 237 and 238:
Page 239 and 240:
Page 241 and 242:
Page 243 and 244:
Page 245 and 246:
Page 247 and 248:
Page 249 and 250:
Page 251 and 252:
Page 253 and 254:
■■❚❙❘Chapter 21Analysis o
Page 255 and 256:
Page 257 and 258:
Page 259 and 260:
Page 261 and 262:
Page 263 and 264:
Page 265 and 266:
Page 267 and 268:
Page 269 and 270:
Page 271 and 272:
■■❚❙❘Part IVSpecial Trial
Page 273 and 274:
■■❚❙❘Chapter 22Intention-
Page 275 and 276:
Page 277 and 278:
Page 279 and 280:
Page 281 and 282:
Page 283 and 284:
■■❚❙❘Chapter 23Subgroup A
Page 285 and 286:
Page 287 and 288:
Page 289 and 290:
Page 291 and 292:
■■❚❙❘Chapter 24Regression
Page 293 and 294:
Page 295 and 296:
Page 297 and 298:
Page 299 and 300:
Page 301 and 302:
Page 303 and 304:
Page 305 and 306:
■■❚❙❘Chapter 25Adjustment
Page 307 and 308:
Page 309 and 310:
Page 311 and 312:
Page 313 and 314:
■■❚❙❘Chapter 26Confoundin
Page 315 and 316:
Page 317 and 318:
Page 319 and 320:
Page 321 and 322:
Page 323 and 324:
■■❚❙❘Chapter 27Interactio
Page 325 and 326:
Page 327 and 328:
Page 329 and 330:
Page 331 and 332:
Page 333 and 334:
Page 335 and 336:
■■❚❙❘Chapter 28RepeatedMe
Page 337 and 338:
Page 339 and 340:
Page 341 and 342:
Page 343 and 344:
Page 345 and 346:
Page 347 and 348:
■■❚❙❘Chapter 29Multiplici
Page 349 and 350:
Page 351 and 352:
Page 353 and 354:
Page 355 and 356:
Page 357 and 358:
■■❚❙❘Chapter 30Missing Da
Page 359 and 360:
Page 361 and 362:
Page 363 and 364:
Page 365 and 366:
Page 367 and 368:
Page 369 and 370:
Page 371 and 372:
■■❚❙❘Chapter 31Interim Mo
Page 373 and 374:
Page 375 and 376:
Page 377 and 378:
Page 379 and 380:
Page 381 and 382:
■■❚❙❘Chapter Part V32Repo
Page 383 and 384:
■■❚❙❘Chapter 32Overview o
Page 385 and 386:
Page 387 and 388:
Page 389 and 390:
Page 391 and 392:
Page 393 and 394:
Page 395 and 396:
■■❚❙❘Chapter 33Trial Prof
Page 397 and 398:
Page 399 and 400:
Page 401 and 402:
Page 403 and 404:
■■❚❙❘Chapter 34Presenting
Page 405 and 406:
Page 407 and 408:
Page 409 and 410:
■■❚❙❘Chapter 35Use of Tab
Page 411 and 412:
Page 413 and 414:
Page 415 and 416:
Page 417 and 418:
Page 419 and 420:
Page 421 and 422:
Page 423 and 424:
Page 425 and 426:
■■❚❙❘Chapter 36Use of Fig
Page 427 and 428:
Page 429 and 430:
Page 431 and 432:
Page 433 and 434:
Page 435 and 436:
Page 437 and 438:
Page 439 and 440:
Page 441 and 442:
Page 443 and 444:
Page 445 and 446:
■■❚❙❘Chapter 37Critical A
Page 447 and 448:
Page 449 and 450:
Page 451 and 452:
Page 453 and 454:
Page 455 and 456:
Page 457 and 458:
■■❚❙❘Chapter 38Meta-Analy
Page 459 and 460:
Page 461 and 462:
Page 463 and 464:
Page 465 and 466:
Page 467 and 468:
Page 469 and 470:
Page 471 and 472:
■■❚❙❘GlossaryGlossary453
Page 473 and 474:
Page 475 and 476:
Page 477 and 478:
Page 479 and 480:
■■❚❙❘AbbreviationsAbbrevi
Page 481 and 482:
Page 483 and 484:
Page 485 and 486:
■■❚❙❘IndexIndex467
Page 487 and 488:
Page 489 and 490:
Page 491 and 492:
Page 493 and 494:
Page 495 and 496:
Page 497 and 498:
show all

Clinical Trials

Create successful ePaper yourself

Delete template?

Save as template?