Artikel
Comparison of Planned and Actual costs related to Investigational Medical Products in Clinical Trials
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Autoren
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Ala Taji Heravi
- Department of Clinical Research, University of Basel, Schweiz
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Anne Henn
- Hospital Pharmacy, University of Basel, Schweiz
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Stefanie Deuster
- Hospital Pharmacy, University of Basel, Schweiz
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Victoria Gloy
- Department of Clinical Research, University of Basel, Schweiz
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Vera Mitter
- Division of gynaecological endocrinology and reproductive Medicine, University of Bern, Schweiz
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Matthias Briel
- Department of Clinical Research, University of Basel, Schweiz
| Veröffentlicht: | 12. Februar 2020 |
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Gliederung
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Background/research question: Conducting high quality randomized clinical trials (RCTs) is challenging and costly. Particularly investigator-initiated RCTs (IICTs) are often not completed as planned. The intervention under investigation is obviously an essential component of a clinical trial contributing to the overall costs to a varying degree. For IICTs in Switzerland, hospital pharmacies offer several services with respect to investigational medicinal products (IMPs) such as development, preparation, manufacturing, and storage etc. Empirical evidence on costs of IMPs for RCTs and the role of hospital pharmacies in the planning of RCTs is lacking. We started a mixed-methods project to compare empirically planned and actual costs related to IMPs in Swiss IICTs.
Methods: In the quantitative part, we include all IICTs that requested services with respect to IMPs at hospital pharmacies in Basel since January 2014. From included IICTs, we extract information on RCT and IMP characteristics in addition to planned and actual IMP costs. We will analyze data to investigate whether characteristics of RCTs and IMPs are associated with any differences between planned and actual IMP costs using statistical software R. In the qualitative part, we will conduct semi-structured interviews with investigators and hospital pharmacy staff to investigate underlying reasons for potential differences between planned and actual IMP costs and to explore specific needs and preferences of IICT investigators and hospital pharmacy staff. We will interview 5-10 principal investigators and three employees from the hospital pharmacy. We will carry out a content analysis of the transcribed interviews using software MAXQDA.
Results: At the conference, we will be able to present the results of our quantitative part including approximately 25 Swiss IICTs.
Conclusion: This project will provide more evidence-based methods to make clinical trials’ budgeting more reliable and efficient from an investigator’s and hospital pharmacy’s perspective. In addition, it will improve collaboration between investigators and hospital pharmacies by exploring the current practices, attitudes, values, needs and preferences of both parties. It will also help funding bodies to better estimate feasibility and costs of IMPs.
Competing interests: The authors declare no conflicts of interest.
