The use of mixed methods in drug discovery: integrating qualitative methods into clinical trials

Berk, Michael, Otmar, Renee, Dean, Olivia, Berk, Lesley and Michalak, Erin 2015, The use of mixed methods in drug discovery: integrating qualitative methods into clinical trials. In Tohen, Mauricio, Bowden, Charles L., Nierenberg, Andrew A. and Geddes, John R. (ed), Clinical trial design challenges in mood disorders, Elsevier, Amsterdam, The Netherlands, pp.59-73, doi: 10.1016/B978-0-12-405170-6.00006-3.

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Title The use of mixed methods in drug discovery: integrating qualitative methods into clinical trials
Author(s) Berk, MichaelORCID iD for Berk, Michael
Otmar, Renee
Dean, OliviaORCID iD for Dean, Olivia
Berk, LesleyORCID iD for Berk, Lesley
Michalak, Erin
Title of book Clinical trial design challenges in mood disorders
Editor(s) Tohen, Mauricio
Bowden, Charles L.
Nierenberg, Andrew A.
Geddes, John R.
Publication date 2015
Chapter number 6
Total chapters 11
Start page 59
End page 73
Total pages 15
Publisher Elsevier
Place of Publication Amsterdam, The Netherlands
Keyword(s) clinical trials
drug discovery
Summary Contemporary methods in clinical trials are pivoted around hypothesis confirmation, not generation. This is a problem for new drug discovery, since the pharmacokinetic or receptor profile of most novel agents do not link to pathophysiology, which is very poorly understood. Therefore, it is difficult to impute the therapeutic potential of a candidate agent. Most psychotropic agents were discovered serendipitously, either through careful clinical observation or by researchers finding unexpected associations in datasets. Methods that increase the ability to detect latent signals in data are needed. These include mixed methods that incorporate qualitative methods into randomized controlled trials.

This chapter proposes a methodology for the integration of mixed methods in clinical trials, fusing qualitative and quantitative methods, and presents an exemplar using this approach.

Mixed methods show potential for signal detection, hypothesis generation, and associations that may be otherwise undetected in traditional clinical trials.
ISBN 9780124051706
Language eng
DOI 10.1016/B978-0-12-405170-6.00006-3
Field of Research 111599 Pharmacology and Pharmaceutical Sciences not elsewhere classified
Socio Economic Objective 970111 Expanding Knowledge in the Medical and Health Sciences
HERDC Research category B1 Book chapter
ERA Research output type B Book chapter
Copyright notice ©2015, Elsevier
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Document type: Book Chapter
Collections: Faculty of Health
School of Medicine
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