Journal article
Qualitative methods in early-phase drug trials: Broadening the scope of data and methods from an RCT of N-acetylcysteine in schizophrenia
M Berk, A Munib, O Dean, GS Malhi, K Kohlmann, I Schapkaitz, S Jeavons, F Katz, M Anderson-Hunt, P Conus, B Hanna, R Otmar, F Ng, DL Copolov, AI Bush
Journal of Clinical Psychiatry | Published : 2011
Abstract
Objective: The pharmacokinetic profile of a drug often gives little indication of its potential therapeutic application, with many therapeutic uses of drugs being discovered serendipitously while being studied for different indications. As hypothesis-driven, quantitative research methodology is exclusively used in early-phase trials, unexpected but important phenomena may escape detection. In this context, this study aimed to examine the potential for integrating qualitative research methods with quantitative methods in early-phase drug trials. To our knowledge, this mixed methodology has not previously been applied to blinded psychopharmacologic trials. Method: We undertook qualitative data..
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Awarded by Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung
Funding Acknowledgements
[ "Dr Berk has received grant/research support from the Stanley Medical Research Foundation, MBF, National Health and Medical Research Council, Beyond Blue, Geelong Medical Research Foundation, Bristol-Myers Squibb, Eli Lilly, GlaxoSmithKline, Organon, Novartis, Mayne Pharma, Servier, and AstraZeneca; has been a paid consultant for AstraZeneca, Bristol-Myers Squibb, Eli Lilly, GlaxoSmithKline, Janssen-Cilag, Lundbeck, Servier, and Pfizer; and has been a paid speaker for AstraZeneca, Bristol-Myers Squibb, Eli Lilly, GlaxoSmithKline, Janssen-Cilag, Lundbeck, Organon, Pfizer, sanofi synthelabo, Servier, Solvay, and Wyeth. Dr Bush is a shareholder and consultant for Prana Biotechnology Ltd and a shareholder in Cogstate Ltd. Drs Munib, Dean, Mali, Schapkaitz, Jeavons, Anderson-Hunt, Conus, Hanna, Ng, and Copolov and Mss Kohlmann, Katz, and Otmar have no personal affiliations or financial relationships with any commercial interest to disclose relative to the article.", "The research team would like to thank the Stanley Medical Research Institute for providing funding for this trial." ]