About the HTA ESIG

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Purpose

1. Empower HTA statisticians, through a platform for sharing and co-developing best practicesShape a platform where HTA statisticians can exchange insights, share experiences, and collaboratively develop best practices, enhancing their role and fostering leadership.
2. Foster interdisciplinary and intradisciplinary scientific dialogue on HTA statistical mattersHarness our collective skills and experience to deliver expert advice to influence HTA and regulatory policy-making.
3. Utilize our collective HTA statistical expertise to provide influential input to policy-makingFoster discussions within the statistician community and across other disciplines to deepen the understanding of HTA statistical matters and foster collaboration.
4. Promote education and awareness about the importance and applications of HTA statisticsBroaden awareness of HTA statistics by leading educational initiatives such as webinars or short courses, highlighting the role and significance of HTA statistics.

 

The HTA ESIG is sponsored by PSI (Statisticians in the Pharmaceutical Industry) and EFSPI (European Federation of Statisticians in the Pharmaceutical Industry).

 

 

Objectives 2024

PurposeObjective
1. Empower HTA statisticians, through a platform for sharing and co-developing best practices
  • Deepen SIG dialogue around EU HTA readiness & strategic role of statisticians
2. Foster interdisciplinary and intradisciplinary scientific dialogue on HTA statistical matters

  • Review and comment on methods and procedural guidelines for HTA

  • Strengthen Social Media communication on HTA statistics/role of HTA statisticians

3. Utilize our collective HTA statistical expertise to provide influential input to policy-making

  • Successful ½d HTA addition to the EFSPI Regulatory Workshop 2024

  • High SIG visibility at PSI 2024 and ISPOR EU 

  • Publish 3 position papers pertaining to EU HTA

  • Strengthen relationship with ISPOR Statistical Methods SIG (Martin) & visibility of technical subgroups

4. Promote education and awareness about the importance and applications of HTA statistics

  • Update HTA handbook

  • Training course (to be delivered in 2025)

  • ITC webinar + PICOs follow-up webinar

 

Upcoming Events

Joint PSI/EFSPI Vaccine SIG Webinar: Statistical and Mechanistic Models for Correlates of Protection

This webinar will explore two different approaches to Correlates of Protection in vaccine development.

Joint PSI/EFSPI Visualisation SIG 'Wonderful Wednesday' Webinars

Our monthly webinar explores examples of innovative data visualisations relevant to our day to day work. Each month a new dataset is provided from a clinical trial or other relevant example, and participants are invited to submit a graphic that communicates interesting and relevant characteristics of the data.

PSI Webinar: Drug Development in Women's Health

The event will open with an overview on drug development in women’s health from a clinician perspective. This talk is followed by talks about statistical challenges when planning IVF studies and analysing the menstrual cycles.

PSI Webinar: Surrogacy

This webinar will provide an overview of surrogacy for licensing and reimbursement. In turn, the need of extensions of the SPIRIT and CONSORT statement will be defined and outlined, with case studies to support.

Joint PSI/EFSPI Pre-Clinical SIG Webinar: Virtual Control Groups in Toxicity Studies

Lea Vaas will present how replacement of concurrent control animals by Virtual Control Groups (VCGs) in systemic toxicity studies may help in contributing to the 3R's principle of animal experimentation: Reduce, Refine, Replace.

Joint PSI/EFSPI Data Science SIG Webinar: Developing Digital Measures (Digital Biomarkers) in Drug Development – insights from Mobilise D consortium

We will share a brief overview of what Mobilise D is and why it is an important step stone in the development of digital biomarkers, and how Mobilise D outputs can be relevant for you.

PSI Career Young Virtual Event (Q2 2024)

This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.

PSI Webinar: Development of Gene Therapies: Strategic, Scientific, Regulatory and Access Considerations

This webinar will cover the history of cell/gene therapy, major regulatory advances, the role of quantitative scientists in drug development of these novel therapeutics, and discuss opportunities for innovation and product advancement.

PSI Career Young Virtual Event (Q3 2024)

This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.

PSI Introduction to Industry Training (ITIT) Course - 2024/2025

An introductory course giving an overview of the pharmaceutical industry and the drug development process as a whole, aimed at those with 1-3 years' experience. It comprises of six 2-day sessions covering a range of topics including Research and Development, Toxicology, Data Management and the Role of a CRO, Clinical Trials, Reimbursement, and Marketing.

PSI Career Young Virtual Event (Q4 2024)

This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.

Latest Jobs

Statistician, Data Science

We have exciting new opportunities available for Study Statisticians, Support Statisticians and Exploratory Statisticians at various levels.