Cross-sector surveys assessing perceptions of key stakeholders towards barriers, concerns and facilitators to the appropriate use of adaptive designs in confirmatory trials

Trials

Volumn 16, Issue 1, 2015, Pages

  Dimairo, Munyaradzi ^a   Julious, Steven A ^a   Todd, Susan ^b   Nicholl, Jonathan P ^a   Boote, Jonathan ^a,c  

^a UNIVERSITY OF SHEFFIELD   (United Kingdom)

^b UNIVERSITY OF READING   (United Kingdom)

^c UNIVERSITY OF HERTFORDSHIRE   (United Kingdom)

Author keywords

Adaptive designs; Barriers; Clinical trials; Confirmatory trials; Early stopping; Flexible designs; Interim analyses; Phase 3; Surveys

Indexed keywords

CLINICAL TRIAL; CONSENSUS DEVELOPMENT; FUNDING; HUMAN; INFORMATION PROCESSING; INTERVIEW; LEARNING; MARKETING; MODEL; ORGANIZATION; PERCEPTION; RATING SCALE; SCIENTIST; ADVERTISING; ATTITUDE; CLINICAL COMPETENCE; CLINICAL TRIAL (TOPIC); CROSS-SECTIONAL STUDY; ECONOMICS; FINANCIAL MANAGEMENT; HEALTH PERSONNEL ATTITUDE; INTERNET; METHODOLOGY; PERSONNEL; PRIVATE SECTOR; PROCEDURES; PSYCHOLOGY; PUBLIC SECTOR; QUESTIONNAIRE; TIME FACTOR;

ADVERTISING AS TOPIC; ATTITUDE; ATTITUDE OF HEALTH PERSONNEL; CLINICAL COMPETENCE; CLINICAL TRIALS AS TOPIC; CROSS-SECTIONAL STUDIES; HUMANS; INTERNET; PERCEPTION; PRIVATE SECTOR; PUBLIC SECTOR; RESEARCH DESIGN; RESEARCH PERSONNEL; RESEARCH SUPPORT AS TOPIC; SURVEYS AND QUESTIONNAIRES; TIME FACTORS;

EID: 84951808541     PISSN: None     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/s13063-015-1119-x     Document Type: Article

References (31)

1. Thompson WR. On the likelihood that One unknown probability exceeds another in view of the evidence of Two samples. Biometrika. 1933;25:285-94.
2. Bauer P, Bretz F, Dragalin V, König F, Wassmer G. Twenty-five years of confirmatory adaptive designs: opportunities and pitfalls. Stat Med. 2015 Mar 16. doi: 10.1002/sim.6472
3. Todd S. A 25-year review of sequential methodology in clinical studies. Stat Med. 2007;26:237-52.
4. Morgan CC, Huyck S, Jenkins M, Chen L, Bedding a, Coffey CS, et al. Adaptive design: results of 2012 survey on perception and Use. Ther Innov Regul Sci. 2014;48:473-81.
5. Elsäßer A, Regnstrom J, Vetter T, Koenig F, Hemmings RJ, Greco M, et al. Adaptive clinical trial designs for European marketing authorization: a survey of scientific advice letters from the European medicines agency. Trials. 2014;15:383.
6. Quinlan J, Gaydos B, Maca J, Krams M. Barriers and opportunities for implementation of adaptive designs in pharmaceutical product development. Clin Trials. 2010;7:167-73.
7. Chow S-C, Corey R. Benefits, challenges and obstacles of adaptive clinical trial designs. Orphanet J Rare Dis. 2011;6:79.
8. Chang M, Chow S-C, Pong A. Adaptive design in clinical research: issues, opportunities, and recommendations. J Biopharm Stat. 2006;16:299-309. discussion 311-2.
9. Kairalla J a, Coffey CS, Thomann M a, Muller KE. Adaptive trial designs: a review of barriers and opportunities. Trials. 2012;13:145.
10. Coffey CS, Levin B, Clark C, Timmerman C, Wittes J, Gilbert P, et al. Overview, hurdles, and future work in adaptive designs: perspectives from a National Institutes of Health-funded workshop. Clin Trials. 2012;9:671-80.
11. Jaki T. Uptake of novel statistical methods for early-phase clinical studies in the UK public sector. Clin Trials. 2013;10:344-6.
12. Dimairo M, Boote J, Julious SA, Nicholl JP, Todd S. Missing steps in a staircase: a qualitative study of the perspectives of key stakeholders on the use of adaptive designs in confirmatory trials. Trials. 2015;16:430.
13. UKCRC Registered Clinical Trials Units Network. [ http://www.ukcrc-ctu.org.uk/ ] Date accessed 14 November 2014.
14. NIHR. NIHR Annual Report 2013/14. NIHR; 2015. [ http://www.nihr.ac.uk/documents/about-NIHR/NIHR-Publications/NIHR-Annual-Reports/NIHR%20Annual%20Report%202013_2014.pdf ]. Date accessed 1 June 2015.
15. Health Technology Assessment (HTA) Programme. [ http://www.nets.nihr.ac.uk/programmes/hta ]. Date accessed 20 August 2014.
16. NIHR HTA Programme: Our people. [ http://www.nets.nihr.ac.uk/programmes/hta/our-people ] Date accessed 20 August 2014.
17. Vagias, WM. (2006). Likert-type scale response anchors. Clemson International Institute for Tourism & Research Development, Department of Parks, Recreation and Tourism Management. Clemson University. [ https://www.clemson.edu/centers-institutes/tourism/documents/sample-scales.pdf ]. Date accessed 11 November 2013.
18. Andrich D. A rating formulation for ordered response categories. Psychometrika. 1978;43:561-73.
19. RUMM Laboratory Pty Ltd. RUMM2030. [ http://www.rummlab.com.au/ ] Date accessed 20 August 2014.
20. Bennett C, Khangura S, Brehaut JC, Graham ID, Moher D, Potter BK, et al. Reporting guidelines for survey research: An analysis of published guidance and reporting practices. PLoS Med. 2011;8:1-11.
21. NIHR Clinical Trials Unit (CTU) Support Funding. [ http://www.nets.nihr.ac.uk/programmes/ctu ] Date accessed 14 November 2014.
22. MRC Network of Hubs for Trials Methodology Research. [ http://www.methodologyhubs.mrc.ac.uk/ ] Date accessed 14 November 2014.
23. Montori VM, Devereaux PJ, Adhikari NKJ, Burns KEA, Eggert CH, Briel M, et al. Randomized trials stopped early for benefit: a systematic review. JAMA. 2005;294:2203-9.
24. Wilcox RA, Djulbegovic B, Moffitt HL, Guyatt GH, Montori VM. Randomized trials in oncology stopped early for benefit. J Clin Oncol. 2008;26:18-9.
25. Bassler D, Montori VM, Briel M, Glasziou P, Guyatt G. Early stopping of randomized clinical trials for overt efficacy is problematic. J Clin Epidemiol. 2008;61:241-6.
26. Detry M, Lewis R, Broglio K, Connor J. Standards for the design, conduct, and evaluation of adaptive randomized clinical trials. 2012.[ http://www.pcori.org/assets/Standards-for-the-Design-Conduct-and-Evaluation-of-Adaptive-Randomized-Clinical-Trials.pdf ]. Date accessed 12 July 2014
27. Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008;337:a1655.
28. FDA. Adaptive designs for medical device clinical studies: draft guidance for industry and Food and Drug Administration staff. 2015.[ http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm446729.pdf ]. Date accessed 20 May 2015.
29. Lin M, Lee S, Zhen B, Scott J, Horne A, Solomon G, Russek-Cohen E. CBER's experience with adaptive design clinical trials. Ther Innov Regul Sci. 2015:2168479015604181. [ http://dij.sagepub.com/content/early/2015/09/15/2168479015604181.abstract ].
30. Bower P, Brueton V, Gamble C, Treweek S, Smith CT, Young B, et al. Interventions to improve recruitment and retention in clinical trials: a survey and workshop to assess current practice and future priorities. Trials. 2014;15:399.
31. Tudur Smith C, Hickey H, Clarke M, Blazeby J, Williamson P. The trials methodological research agenda: results from a priority setting exercise. Trials. 2014;15:32.