The current decade will bring an unprecedented change to the way drugs are brought to market. Fueled by changes to the clinical trial design and execution and how regulators assess drugs, the health technology assessments (HTAs) will evolve and consider the confluence of three areas: methods, data, and technology. Methods will have to account for the increased complexity of documenting the value of the drugs in more precisely defined indications and draw on more and more advanced statistical analyses and epidemiological and data science approaches. The appropriateness of the methods will be tested using more complex data, often leveraging information across health care systems. Data access and processing will be facilitated using technology and enabling rapid derivation of the insight at country level for compounds entering the market.

The presentation will focus on the interrelationship between methods, data and technology and, using a case study approach, showcase how we are already on the way towards the new HTA paradigm. The necessary conditions to ensure transparency of research and the HTA assessment will be described.

Learning Objectives:

Describe how the changes to clinical trial design and execution and the regulatory assessment process and how they will impact HTAs
Present key factors influencing the relationship between methods, data and technology in the HTA assessment process in the future.
Outline the roadmap towards the new data-driven HTA paradigm

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