Masterarbeit

The role of animal studies in declining efficiency of pharmaceutical research and development from the regulatory perspective ***

Dr. Petra Starck-Lantová (2018)

Summary
Language: English
Currently, pharmaceutical research and development are branded by declining efficiency. The costs to develop and gain marketing approval for a new prescription drug average at US$ 2.6 billion and exceed costs for research and development.  Such situation creates pressure on the industry to achieve more predictive efficacy and safety, with less time, staff and resources. In result – instead of the perception of clinical need – it is the enormous costs and high risk that shape the market and make it increasingly difficult to obtain capital to fund innovation. When looking for reasons of this declining efficiency factors like expectations on safety, high failure rates in early drug discovery, and high attrition rates in clinical research caused by rising protocol complexity, long development timelines and low translational value of nonclinical research can be identified. Among these factors animal studies turned out to play a major role.
The use of animal studies has a long tradition in pharmaceutical development, but doubts about their value are growing. Many stakeholders call therefore for developing new paradigms that would reduce reliance on traditional models and re-direct the testing towards state-of-the-art alternative methods. Animal studies are frequently conducted in early phases of medicine development, especially for safety/toxicity reasons, improving their quality and translational value has therefore a great potential for increasing the efficiency of the whole developmental process. Because entering the clinical phase with unreliable data bears the risk of immense costs and the health of trial participants, the quality of nonclinical research should have at least as high priority for investigators and regulators as the quality of clinical research.
This thesis summarizes regulatory requirements for animal use, presents different types of animal models, and provides numerous examples illustrating the limitations and flaws of animal experimentation in its current form. It advocates the use of validated alternative approaches and improved study designs, and it reviews quality standards/good practices that are rarely considered. Because progress in methodical aspects of animal research or in the use of alternative methods can contribute to improved efficiency of pharmaceutical discovery, suggestions on integrating requirements of quality standards in regulatory guidelines are made.
Pages: 59