Qualitative Methods in Early-Phase Drug Trials
| Autor: | David L. Copolov, Michael Berk, Ian Schapkaitz, Renée Otmar, Barbara Hanna, Fiona Katz, Kristy Kohlmann, Felicity Ng, Gin S Malhi, Olivia M Dean, Ahmed Munib, Philippe Conus, Murray Anderson-Hunt, Ashley I. Bush, S Jeavons |
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| Rok vydání: | 2010 |
| Předmět: |
Adult
Male medicine.medical_specialty Qualitative property Context (language use) Placebo law.invention 03 medical and health sciences 0302 clinical medicine Double-Blind Method Randomized controlled trial Rating scale law medicine Humans Psychiatry Psychiatric Status Rating Scales business.industry Data Collection Free Radical Scavengers Middle Aged medicine.disease Acetylcysteine 030227 psychiatry 3. Good health Clinical trial Psychiatry and Mental health Schizophrenia Female Schizophrenic Psychology business 030217 neurology & neurosurgery Qualitative research Clinical psychology |
| Zdroj: | The Journal of clinical psychiatry |
| ISSN: | 0160-6689 |
| DOI: | 10.4088/jcp.09m05741yel |
| Popis: | 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 analysis of clinical observations on the dataset of a randomized double blind placebo controlled trial of N acetylcysteine (NAC) in patients with DSM IV TR diagnosed schizophrenia (N = 140). Textual data on all participants deliberately collected for this purpose were coded using NVivo 2 and emergent themes were analyzed in a blinded manner in the NAC and placebo groups. The trial was conducted from November 2002 to July 2005. RESULTS The principal findings of the published trial could be replicated using a qualitative methodology. In addition significant differences between NAC and placebo treated participants emerged for positive and affective symptoms which had not been captured by the rating scales utilized in the quantitative trial. Qualitative data in this study subsequently led to a positive trial of NAC in bipolar disorder. CONCLUSIONS The use of qualitative methods may yield broader data and has the potential to complement traditional quantitative methods and detect unexpected efficacy and safety signals thereby maximizing the findings of early phase clinical trial research. TRIAL REGISTRATION www.anzctr.org.au Identifier: ACTRN12605000363684. |
| Databáze: | OpenAIRE |
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