Ethics in clinical trial regulation : ethically relevant issues from EMA inspection reports
| Autor: | G. J. M. W. van Thiel, C. C. Gispen-de Wied, J.J.M. van Delden, Nancy S. Breekveldt, Rosemarie D. L. C. Bernabe |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2019 |
| Předmět: |
media_common.quotation_subject
education 030204 cardiovascular system & hematology GCP non-compliance findings Marketing authorization GCP inspection Research ethics 03 medical and health sciences 0302 clinical medicine Clinical trials Medicine Humans 030212 general & internal medicine media_common Medicine(all) Clinical Trials as Topic Ethical issues business.industry Marketing authorization application fungi food and beverages General Medicine Deliberation Ethically relevant findings Clinical trial Engineering ethics business |
| Zdroj: | Current Medical Research and Opinion, 35(4), 637. Informa Healthcare |
| ISSN: | 0300-7995 |
| Popis: | Background: Within the EU, regulators are obliged to take ethical issues into consideration during marketing authorization deliberation. The goal of this manuscript is to identify what kinds of ethical issues regulators encounter during marketing authorization application deliberations, and the incidence of these ethical issues. Methods: This study used an EMA-provided Excel file that contains all the GCP non-compliance findings from all inspection reports from 2008–2012. There were 112 medicinal products and a total of 288 clinical trial sites. There were a total of 4014 GCP non-compliance findings. The findings that were ethically relevant were extracted using NVivo 10.0 and categories for the ethically relevant findings (ERFs) were created. Note was taken of the incidence of ERFs for each category and the inspectors’ gradings of these findings were extracted. This study also looked at the mean and the maximum number of ERFs per grading per medicinal product application, as well as the number of medicinal products with at least one ERF and those with at least major ERFs. Results: With multiple coding, there were 1685 ERFs. ERFs were present in almost all of the medicinal products (97.3%). The majority of ERFs were graded as major. At least major ERFs were present in almost all medicinal products with ERFs. The categories with the highest number of ERFs were protocol issues, patient safety, and professionalism issues. In terms of the density of combined critical and major findings, monitoring and oversight, protocol issues, and respect for persons top the list. This study also showed that, on average, there were 7.54 major and 2.95 critical ERFs per medicinal product application, although ERFs can increase to 30 major and 12 critical. Conclusion: Regulators regularly encounter ERFs that at least “might adversely affect the rights, safety or well-being of the subjects”. It remains to be explored how regulators respond to these ethical issues. |
| Databáze: | OpenAIRE |
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