Integrating new approaches for clinical development: translational research and relative effectiveness.

Translational research and relative effectiveness are being incorporated into drug development programs to meet the demands for more robust evidence generation to support the value of new therapies. Translational research includes translating basic research into clinical practice, controlled clinical trials into potential clinical implications, evidence-based guidelines into routine clinical practice and standard practices into population health. These research concepts link with real-world outcomes, and feed into each other to improve the efficiency of research.

Integrating scientific and real-world evidence within and beyond the drug development process.

Newly developed healthcare treatments face a complex environment with many stakeholders who can accelerate or decelerate adoption, most notably the healthcare system payers. Understanding and integrating their needs earlier in clinical development will ensure a smoother transition from bench to bedside. This paper describes a new approach to shaping a more effective complementary process of 'value' evidence generation both in and outside the clinical drug development process.

A framework for pharmaceutical value-based innovations.

The rapidity of change and increasing complexity of today's healthcare environment dictates that pharmaceutical companies refine their drug development process to ensure that products provide maximal value to consumers. Innovation should receive the support and encouragement it deserves but the balance between cost of therapy and enhanced benefits to the end users, the patients, must not be compromised. The health or quality-of-life outcomes that therapies are likely to achieve need to be clearly stated for patients so they know what to expect before beginning treatment.

[Design and birth of drugs].

Today the design of new clinical entities uses highly sophisticated techniques. This design is a step by step procedure: first selection and validation of the therapeutic targets, where the contribution of genomics is very important; then, setting up the different screening tests. This step permits to detect the potentially active molecules, which will be optimised, before being tested in healthy volunteers and then in patients.