Research

The three pillars of CIRS activities

Metrics

Evidence-driven insights into company and agency performance

Quality

Improving decision-making processes

Alignment

Converging stakeholder priorities and processes to accelerate patient access

CIRS provides unique insights and an independent viewpoint on the performance of companies, regulatory and HTA agencies through its metrics programmes. Data are collected and analysed to give a better understanding of regulatory and HTA assessment times and evidentiary requirements. This form of benchmarking details regulatory and HTA processes and practices, identifies where improvements can be made and informs company and agency strategies.

CIRS works with companies and agencies to evaluate the quality of their processes, identify challenges, and implement best practices. Tools developed from these projects support decision-making practices and their documentation in general or are specific to areas such as benefit-risk assessment. The aim is to foster learning and improve transparency, predictability and consistency of critical decisions during development, regulatory review and HTA.

Through collaborative research projects and multi-stakeholder workshops, CIRS promotes harmonisation and alignment across HTA and regulatory agencies, as well as between HTAs and regulators themselves. Not only does this facilitate capacity building but also helps to enable more efficient and effective development of medicines.

These three pillars form the foundation of CIRS’ research agenda, which is reviewed every three years.

Frequently asked questions (FAQs)

Metrics help pharmaceutical companies, regulators and HTA agencies to benchmark their performance and identify where improvements can be made. Through its metrics research programmes—such as OpERA, HTADock and GEMM —CIRS supports agencies and companies in using data to enable evidence-based decision making, strengthen regulatory and HTA processes, and accelerate patient access to medicines globally.

CIRS has developed and validated several tools in collaboration with companies and agencies to assess the quality of decision-making practices:

  • Assessing Good Review Practices – survey & scorecard
  • Quality of Decision Making Orientation Scheme (QoDoS) tool
  • UMBRA benefit-risk framework & template

More information on these tools can be found in CIRS R&D Briefing 87. If you have any questions, please email us at cirs@cirsci.org

Alignment between regulators and HTA agencies helps to enable more efficient and effective development of medicines. By coordinating regulatory and HTA evidentiary requirements and timelines, pharmaceutical companies can deliver safe, effective and valuable treatments to patients.

CIRS facilitates this alignment by providing a neutral platform for multi-stakeholder dialogue and research that promotes cross-learning and identification of best practices.