Use of the equivalence approach in reproduction health clinical trials

Statistics in Medicine

Volumn 20, Issue 23, 2001, Pages 3571-3578

  Piaggio, Gilda ^a   Pinol, Alain P Y ^a  

^a WORLD HEALTH ORGANIZATION   (Switzerland)

Author keywords

[No Author keywords available]

Indexed keywords

ADULT; ARTICLE; CALCULATION; CLINICAL RESEARCH; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DATA ANALYSIS; FEMALE; HUMAN; HYPOTHESIS; INTERMETHOD COMPARISON; METHODOLOGY; PUBLICATION; REPRODUCTIVE HEALTH; STANDARD; STATISTICAL ANALYSIS; TECHNIQUE; TREATMENT OUTCOME; CONFIDENCE INTERVAL; CONTRACEPTION; LOW BIRTH WEIGHT; NEWBORN; PHARMACOKINETICS; PREGNANCY; PRENATAL CARE; RANDOMIZED CONTROLLED TRIAL; REPRODUCTION; SAMPLE SIZE; STATISTICS; UTERUS BLEEDING;

LEVONORGESTREL; MISOPROSTOL; OXYTOCIC AGENT;

CONFIDENCE INTERVALS; CONTRACEPTION; FEMALE; HUMANS; INFANT, LOW BIRTH WEIGHT; INFANT, NEWBORN; LEVONORGESTREL; MISOPROSTOL; OXYTOCICS; PREGNANCY; PRENATAL CARE; RANDOMIZED CONTROLLED TRIALS; REPRODUCTIVE MEDICINE; SAMPLE SIZE; STATISTICS; THERAPEUTIC EQUIVALENCY; UTERINE HEMORRHAGE;

EID: 0035892614     PISSN: 02776715     EISSN: None     Source Type: Journal    
DOI: 10.1002/sim.1078     Document Type: Article

References (50)

1. Significance testing to establish equivalence between treatments with special reference to data in the form of 2 × 2 tables
2. Sample size requirements for evaluating a conservative therapy
3. Proving the null hypothesis in clinical trials
4. Test statistics and sample size formulae for comparative binomial trials with null hypothesis of non-zero risk difference or non-unity relative risk
5. Sample sizes for bioequivalence studies
6. General design issues in efficacy, equivalency and superiority trials
7. Comparison of tests and sample size formulae for proving therapeutic equivalence based on the difference of binomial probabilities
8. Trials to assess equivalence: The importance of rigorous methods
9. Therapeutic equivalence investigations: Statistical considerations
10. Practical issues in equivalence trials
11. Sequential designs for equivalence studies
12. Methodological considerations in the design of the WHO Antenatal Care Randomized Controlled Trial
13. Equivalence and non-inferiority trials
14. Design and interpretation of clinical trials
15. Planning and monitoring of equivalence studies
16. WHO antenatal care randomized trial for the evaluation of a new model of routine antenatal care
17. The WHO multicentre double-blind randomized controlled trial to evaluate the use of misoprostol in the management of the third stage of labour
18. The between orally administered misoprostol and standard management
19. Comparative study of the effects of two once-a-month injectable steroidal contraceptives (Mesigyna and Cyclofem ®) on lipid and lipoprotein metabolism
20. Prostaglandins for prevention of postpartum haemorrhage (Cochrane Review)
21. A randomized clinical trial comparing oral Misoprostol with synthetic oxytocin or Syntometrine in the third stage of labour
22. Misoprostol compared with methylergometrine Prostaglandins for the prevention of postpartum haemorrhage: A double-blind randomized trial
23. A double-blind placebo controlled randomized trial of misoprostol and oxytocin in the management of the third stage of labour
24. A multicentre randomized controlled trial of oral misoprostol and i.m syntometrine in the management of the third stage of labour
25. Randomized comparison of rectal misoprostol with syntometrine for management of third stage of labour
26. WHO systematic review of randomized controlled trials of routine antenatal care
27. Alternative prenatal care: Impact of reduced visit frequency, focused visits and continuity of care
28. A study of two antenatal care models in a rural setting in Zimbabwe
29. Effect of frequency of prenatal care visits on perinatal outcome among low-risk women
30. Randomised controlled trial of a reduced-visits programme of antenatal care in Harare, Zimbabwe
31. A randomized controlled trial comparing two schedules of antenatal visits: The antenatal care project
32. Interventions for emergency contraception (Cochrane Review)
33. A prospective randomized comparison of levonorgestrel with the Yuzpe regimen in post-coital contraception
34. Randomised controlled trial of levonorgestrel versus the Yuzpe regimen of combined oral contraceptives for emergency contraception
35. Comparison of three single doses of mifepristone as emergency contraception: A randomized trial
36. A clinical study on 600 cases of mifepristone for emergency contraception
37. Clinical observation of three lower doses of mifepristone for emergency contraception
38. Low doses of mifepristone for emergency contraception
39. Similar, the same or just not different: A guide for deciding whether treatments are clinically equivalent
40. A multiple testing procedure for clinical trials
41. Designs for group sequential tests
42. Interim analyses in randomized clinical trials
43. Statistical and ethical issues in monitoring clinical trials
44. A trial of shortened zidovudine regimens to prevent mother-to-child transmission of human immunodeficiency virus type 1
45. Group sequential methods in the design and analysis of clinical trials
46. Discrete sequential boundaries for clinical trials