Abstract
Since 2000 the investments of biotech and pharmaceutical companies required for one successful drug launch have increased by more than 50% to about $1,7 Bill. The main reason was found to lie in the prolongation of the "Critical path" between the discovery of a new drug candidate and the final approval whereas only about 8% of all candidates entering preclinical development reach the market. Demonstrating medical utility of a new drug, i.e. appropriate patient safety and treatment efficacy, takes a considerable amount of budget and time. The aim of the Master Thesis was to provide a comprehensive overview about ePRO solutions as logical extension of EDC systems as well as to give an estimation about the economic impact on clinical trials. The work is addressed to managers within the biotech and pharmaceutical industry responsible for the definition and management of clinical trials. Typical clinical indications utilising ePRO solutions, requirements for regulatory compliance, and the impact on biometric planning have been elaborated comprehensively. Because of the specifications have to match with the requirements of the protocol and the abilities of the study subjects major challenges and obstacles are mentioned giving advice to select the best fitting technology. The results of a cost/benefit analysis performed on estimates for Phase III trials gives evidence that the consequent utilisation of ePRO could save up to 50% of overall trial budget compared to conservative paper based trials.
Originalsprache | Englisch |
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Gradverleihende Hochschule |
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Publikationsstatus | Veröffentlicht - 2005 |
Research Field
- Nicht definiert