During medicine development, two main drivers help to establish a body of evidence about a product’s safety and efficacy. The first of these is demand from regulators: evidence is needed as a result of regulations and other requirements. The second is the supply of evidence from pharmaceutical companies, generated as a result of their development plans.
An important question then arises – are these two drivers properly aligned? In many cases, there will be ways in which medicine development timelines can be shortened and costs reduced, while retaining standards of quality, safety and efficacy. Improvements can be made either to evidence requirements, or to the way in which evidence is generated and supplied by pharmaceutical companies, and such improvements will help to direct development towards meeting priority health care needs.
The following projects have addressed issues in this area:
- Biomarkers and assessment of drug efficacy in cardiovascular disease
- Biopharmaceuticals as Challenges to the Regulatory System
- Development of a practice-based drug monitoring approach for assessing appropriateness and outcomes of new drug prescribing
- The multiple parameter risk response outcome score
- Innovations in Post-Marketing Safety Research
- Lessons learned from Escher and CBG-MEB Regulatory Science Projects
- Methods to improve the efficiency of confirmatory clinical trials
- Non-inferiority trials: methodological and regulatory challenges
- Off-target effects of RAAS-inhibition
- Personalized Medicine