Advantages for all actors of the health care system
Advancements in the field of personalized cancer medicine can improve patient care and increase the success rate of the physicians. Furthermore, they can bring advantages to both the health care system and the co-insurers: they reduce the number of treatments given to the non-responders as well as of the supportive therapy for adverse drug reactions, and therefore lower the cost/performance ratio and the overall costs per patient.
These advancements also open up the following possibilities for the pharmaceutical industry:
- Biomarkers can increase the success rate of phase I and II studies in several ways. For example, by identifying the most suitable patients, by establishing the therapeutic dose range, and by testing the hypothesis on the mechanism of action.
- Biomarkers can serve as early indicators for safety and efficacy in phase I and II studies, thereby accelerating the decision for stopping or continuing a study.
- Biomarkers for responders of a phase II study can be valid as criterion for patient selection in the subsequent phase III study. This would increase the response rate of the phase III study and therefore reduce the required number of patients for this study.
These possibilities would increase the success rate of the clinical development and therefore reduce the overall costs of pharmaceutical research and development.