Affiliations: [a]
School of Social Work, College of Health and Human Sciences, Colorado State University, Fort Collins, CO, USA
| [b]
Luskin School of Public Affairs, University of California, Los Angeles, CA, USA
| [c] Milwaukee, WI, USA
Correspondence:
[*]
Address for correspondence: Shannon Hughes, Assistant Professor, School of Social Work, Colorado State University, 1586 Campus Delivery, Fort Collins, CO 80523, USA. Tel.: +1 970 491 5654; Fax: +1 970 491 7280; E-mail: [email protected].
Abstract: BACKGROUND: Actual assessment methods for identifying adverse events (AEs) in clinical trials have received less scrutiny than underreporting of AEs. OBJECTIVE: To investigate whether AE assessment has changed over time for three psychotropic drugs with turbulent histories of safety concerns since their U.S. approval. METHODS: From industry-funded published trials of atomoxetine, duloxetine, and olanzapine retrieved from PubMed for 1996–2004 (n = 33) and 2009–2014 (n = 40), verbatim AE assessment and numbers of words describing efficacy and safety assessment were extracted. RESULTS: Closest to drug approval (1996–2004), 77.8% of atomoxetine trials used open-ended questioning only, 50% of duloxetine trials used spontaneous self-report or clinician observation only, and 66.7% of olanzapine trials used a scale (primarily for extrapyramidal symptoms) and one former method. Recent studies (2009–2014) showed less rigor and transparency: 35.3% of atomoxetine and 64.7% of duloxetine studies reported no AE assessment method and 50% of olanzapine studies no longer used scales. Overall, the mean number of words describing efficacy assessment increased from 202 to 309 but decreased from 83 to 63 for safety. CONCLUSION: Trial methodology for assessing psychotropic drug safety remains an underdeveloped area with major public health implications.
Keywords: Drug safety, clinical trial methodology, psychotropic drugs, adverse events
