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. Attached Files Name Description MIMEType Size Downloads Title The use of mixed methods in drug discovery: integrating qualitative methods into clinical trials Author(s) Berk, Michael orcid.org/0000-0002-5554-6946 Otmar, Renee Dean, Olivia orcid.org/0000-0002-2776-3935 Berk, Lesley orcid.org/0000-0002-3677-7503 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 methods pharmacology psychiatry qualitative 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 0124051707 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 Persistent URL http://hdl.handle.net/10536/DRO/DU:30081497 Document type: Book Chapter Collections: Faculty of Health School of Medicine Related Links Link Description Connect to published version Go to link with your DU access privileges     Unless expressly stated otherwise, the copyright for items in DRO is owned by the author, with all rights reserved. Versions Version Filter Type Fri, 19 Feb 2016, 13:42:15 EST Sat, 20 Feb 2016, 04:02:33 EST Sat, 20 Feb 2016, 05:11:02 EST Thu, 14 Apr 2016, 15:34:16 EST Thu, 14 Apr 2016, 15:37:56 EST Filtered Full Citation counts:   Cited 0 times in TR Web of Science Cited 2 times in Scopus Search Google Scholar Access Statistics: 708 Abstract Views, 3 File Downloads  -  Detailed Statistics Created: Fri, 19 Feb 2016, 13:42:15 EST

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