Attitudes and opinions regarding confirmatory adaptive clinical trials: A mixed methods analysis from the Adaptive Designs Accelerating Promising Trials into Treatments (ADAPT-IT) project

Trials

Volumn 17, Issue 1, 2016, Pages

  Meurer, William J ^a   Legocki, Laurie ^a   Mawocha, Samkeliso ^a   Frederiksen, Shirley M ^a   Guetterman, Timothy C ^a   Barsan, William ^a   Lewis, Roger ^b   Berry, Donald ^c   Fetters, Michael ^a  

^a UNIVERSITY OF MICHIGAN MEDICAL SCHOOL   (United States)

^b HARBOR UCLA MEDICAL CENTER   (United States)

^c UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

Author keywords

Adaptive clinical trials; Bayesian statistics; Clinical trials; Emergency medicine; Mixed methods research; Neurology

Indexed keywords

CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; DOCTOR PATIENT RELATION; EDUCATION; EMERGENCY MEDICINE; HUMAN; INFORMATION PROCESSING; NEUROLOGY; PERCEPTION; PHASE 3 CLINICAL TRIAL; SCIENTIST; STATISTICS; TRUST; VALIDITY; VELOCITY; VISUAL ANALOG SCALE; ADULT; ATTITUDE; CLINICAL TRIAL (TOPIC); CULTURAL ANTHROPOLOGY; FEMALE; FOOD AND DRUG ADMINISTRATION; MALE; METHODOLOGY; MIDDLE AGED; UNITED STATES;

ADULT; ATTITUDE; CLINICAL TRIALS AS TOPIC; CULTURE; FEMALE; FOCUS GROUPS; HUMANS; MALE; MIDDLE AGED; RESEARCH DESIGN; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION; VISUAL ANALOG SCALE;

EID: 84979680959     PISSN: None     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/s13063-016-1493-z     Document Type: Article

References (30)

1. Meurer WJ, Lewis RJ, Tagle D, Fetters MD, Legocki L, et al. An overview of the Adaptive Designs Accelerating Promising Trials Into Treatments (ADAPT-IT) project. Ann Emerg Med. 2012;60:451-7.
2. Chow S-C, Chang M. Adaptive design methods in clinical trials - a review. Orphanet J Rare Dis. 2008;3:11-1.
3. Food and Drug Administration. Guidance for industry: adaptive design clinical trials for drugs and biologics. 2010. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM201790.pdf. Accessed 25 Apr 2010.
4. Gallo P, Chuang-Stein C, Dragalin V, Gaydos B, Krams M, et al. Adaptive designs in clinical drug development - an executive summary of the PhRMA Working Group. J Biopharm Stat. 2006;16:275-83. discussion 285-91, 293-8, 311-2.
5. Hung HMJ, O'Neill RT, Wang S-J, Lawrence J. A regulatory view on adaptive/flexible clinical trial design. Biom J. 2006;48:565-73.
6. Kairalla J, Coffey C, Thomann M, Muller K. Adaptive trial designs: a review of barriers and opportunities. Trials. 2012;13:1-9.
7. Orloff J, Douglas F, Pinheiro J, Levinson S, Branson M, et al. The future of drug development: advancing clinical trial design. Nat Rev Drug Discov. 2009;8:949-57.
8. Coffey CS, Levin B, Clark C, Timmerman C, Wittes J, 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.
9. Mahajan R, Gupta K. Food and drug administration's critical path initiative and innovations in drug development paradigm: Challenges, progress, and controversies. J Pharm Bioallied Sci. 2010;2:307-13.
10. Zerhouni E. The NIH Roadmap. Science. 2003;302:63-72.
11. Morgan CC, Huyck S, Jenkins M, Chen L, Bedding A, et al. Adaptive design: results of 2012 survey on perception and use. Ther Innov Regul Sci. 2014;48:473-81.
12. 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.
13. Greenbaum TL. The handbook for focus group research, vol. xvi. Thousand Oaks: Sage Publications; 1998. p. 262.
14. Krueger RA, Casey MA. Focus groups: a practical guide for applied research. Thousand Oaks: Sage Publications; 2009.
15. Legocki LJ, Meurer WJ, Frederiksen S, Lewis RJ, Durkalski VL, et al. Clinical trialist perspectives on the ethics of adaptive clinical trials: a mixed-methods analysis. BMC Med Ethics. 2015;16:27.
16. Guetterman TC, Fetters MD, Legocki LJ, Mawocha S, Barsan WG, et al. Reflections on the adaptive designs accelerating promising trials into treatments (ADAPT-IT) process-findings from a qualitative study. Clin Res Regul Aff. 2015;32:121-30.
17. Tong A, Sainsbury P, Craig J. Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups. Int J Qual Health Care. 2007;19:349-57.
18. Cearnal L. The birth of the NETT: NIH-funded network will launch emergency neurological trials. Ann Emerg Med. 2006;48:726.
19. Connor JT, Broglio KR, Durkalski V, Meurer WJ, Johnston KC. The Stroke Hyperglycemia Insulin Network Effort (SHINE) trial: an adaptive trial design case study. Trials. 2015;16:72.
20. Connor JT, Elm JJ, Broglio KR, Investigators A-I ESETT. Bayesian adaptive trials offer advantages in comparative effectiveness trials: an example in status epilepticus. J Clin Epidemiol. 2013;66:S130-7.
21. Muhr T. ATLAS.ti 6.0 (Version 6). Berlin: ATLAS.ti Scientific Software Development GmbH; 2004.
22. Miles MB, Huberman AM. Qualitative data analysis: an expanded sourcebook, vol. xiv. Thousand Oaks: Sage Publications; 1994. p. 338.
23. Fetters MD, Curry LA, Creswell JW. Achieving integration in mixed methods designs-principles and practices. Health Serv Res. 2013;48:2134-56.
24. Hay M, Thomas DW, Craighead JL, Economides C, Rosenthal J. Clinical development success rates for investigational drugs. Nat Biotech. 2014;32:40-51.
25. DiMasi JA, Feldman L, Seckler A, Wilson A. Trends in risks associated with new drug development: success rates for investigational drugs. Clin Pharmacol Ther. 2010;87:272-7.
26. Kaitin KI, DiMasi JA. Pharmaceutical innovation in the 21st century: new drug approvals in the first decade, 2000-2009. Clin Pharmacol Ther. 2011;89:183-8.
27. Kola I, Landis J. Can the pharmaceutical industry reduce attrition rates? Nat Rev Drug Discov. 2004;3:711-5.
28. Lara PN, Redman MW. The hazards of randomized phase II trials. Ann Oncol. 2012;23:7-9.
29. Simon R. How large should a phase II trial of a new drug be? Cancer Treat Rep. 1987;71:1079-85.
30. Dragalin V. Adaptive designs: terminology and classification. Drug Inf J. 2006;40:425-35.