Multiplicity: Discussion points from the Statisticians in the Pharmaceutical Industry multiplicity expert group

Pharmaceutical Statistics

Volumn 12, Issue 5, 2013, Pages 255-259

  Phillips, Alan ^a   Fletcher, Chrissie ^b   Atkinson, Gary ^c   Channon, Eddie ^d   Douiri, Abdel ^e   Jaki, Thomas ^f   Maca, Jeff ^g   Morgan, David ^h   Roger, James Henry ^i,j   Terrill, Paul ^k  

^a ICON CLINICAL RESEARCH   (United States)

^b AMGEN LTD   (United Kingdom)

^c PFIZER INC   (United States)

^d Chirostat Statistical Consulting   (United Kingdom)

^e KING'S COLLEGE LONDON   (United Kingdom)

^f LANCASTER UNIVERSITY   (United Kingdom)

^g IQVIA   (United States)

^h IPSEN   (France)

ⁱ Livedata (UK) Ltd CHINNOR   (United Kingdom)

^j LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE   (United Kingdom)

^k MDSL International   (United Kingdom)

more..

Author keywords

hypothesis tests; multiplicity; secondary endpoints; simultaneous CIs; type I error

Indexed keywords

ARTICLE; CLINICAL TRIAL (TOPIC); CONFIDENCE INTERVAL; CONSENSUS; DRUG DEVELOPMENT; DRUG INDUSTRY; STATISTICAL ANALYSIS; STRATEGIC PLANNING;

HYPOTHESIS TESTS; MULTIPLICITY; SECONDARY ENDPOINTS; SIMULTANEOUS CIS; TYPE I ERROR;

CLINICAL TRIALS AS TOPIC; CONFIDENCE INTERVALS; DRUG INDUSTRY; HUMANS; RESEARCH DESIGN; RESEARCH PERSONNEL;

EID: 84883809891     PISSN: 15391604     EISSN: 15391612     Source Type: Journal    
DOI: 10.1002/pst.1584     Document Type: Article

References (17)

1. CPMP points to consider document. Multiplicity, (2002). Available at http://www.emea.europa.eu/docs/en\-GB/document\-library/Scientific\-guideline/ 2009/09/WC500003640.pdf (accessed 09.07.2013).
2. Concept paper on the need for a guideline on multiplicity issues in clinical trials. Available at http://www.ema.europa.eu/docs/en\-GB/document\- library/Scientific\-guideline/2012/05/WC500127901.pdf (accessed 09.07.2013).
3. ICH E9 Expert Working Group. Statistical principles for clinical trials: ICH harmonized tripartite guideline. Statistics in Medicine 1999; 18: 1905-1942.
4. Storey JD, Tibshirami R,. Statistical significance for genome wide studies. Proceedings of the National Academy Of Science 2003; 100 (16): 9440-9445. (Pubitemid 37033947)
5. Dmitrienko A, Tamhane A, Wiens B,. General multistage gatekeeping procedures. Biometrical Journal 2008; 50: 667-677.
6. Dmitrienko A, Wiens BL, Tamhane AC, Wang X,. Tree-structured gatekeeping tests in clinical trials with hierarchically ordered multiple objectives. Statistics in Medicine 2007; 26: 2465-2478. (Pubitemid 46784205)
7. Bretz F, Maurer W, Brannath W, Posch M,. A graphical approach to sequentially rejective multiple test procedures. Statistics in Medicine 2009; 28: 586-604.
8. Burman CF, Sonesson C, Guilbaud O,. A recycling framework for the construction of Bonferroni-based multiple tests. Statistics in Medicince 2009; 28: 739-761.
9. Klokars A, Sax G,. Multiple comparisons. Sage Publications: Beverly Hills, 1986.
10. Dmitrienko A, Tamhane AC, Bretz F,. Multiple testing problems in pharmaceutical statistics. Biometrical Journal 2012; 54 (4): 579-580.
11. Glimm E, Maurer W, Bretz F,. Hierachical testing of multiple endpoints in group sequential trials. Statistics in Medicine 2009; 29: 219-228, DOI: 10.1002/sim.3784.
12. Tamhane AC, Mehta CR, Liu L,. Testing a primary and a secondary endpoint in a group sequential design. Biomterics 2010; 66: 1174-1184.
13. Dmitrienko A, D'Agostino RB, Huque MF,. Key multiplicity issues in clinical drug development. Statistics in Medicine 2012; 32: 1079-1111, DOI: 10.1002/sim.5642.
14. Posch M, Koenig F, Branson M, Brannath W, Dunger-Baldauf C, Bauer P,. Testing and estimation in flexible group sequential designs with adaptive treatment selection. Statistics in Medicine 2005; 24: 3697-3714. (Pubitemid 43115726)
15. Bauer P, Röhmel J, Maurer W, Hothorn L,. Testing strategies in multi-dose experiments including active control. Statistics in Medicine 1998; 17 (18): 2133-2146. (Pubitemid 28442020)
16. Hayter AJ, Hsu JC,. On the relationship between stepwise decision procedures and confidence sets. Journal of the American Statistical Association 1994; 89 (425): 128-136.
17. Channon EJ, McEntegart DJ,. Confidence intervals and p-values for Williams' and other step-down multiple comparison tests against control. Journal of Biopharmaceutical Statistics 2001; 11 (1-2): 45-63. (Pubitemid 32642828)