RWE 201 – Latvia – Making Early Strides to Implement RWE and RWD Initiatives

 

Latvia is actively working on initiatives to implement Real-World Evidence (RWE) and Real-World Data (RWD) in its healthcare system, with a focus on improving healthcare decision-making and enhancing the use of health technology assessment.

The Innovative Medicines Initiative (IMI) has set up the GetReal Initiative project to drive the adoption of RWE in healthcare decision-making across Europe, including Latvia. This initiative aims to tackle challenges related to data discoverability, quality, and accessibility, and bridge the gap between RWE and conventional randomised controlled trial approaches. It also offers education and training resources through the GetReal Academy.

In Latvia, there is no formal requirement for RWD submission within the reimbursement dossier. The evidence required for the decision-making process should be collected through randomized controlled clinical trials and is considered for decisions only when the results are published. However, RWD can be a supportive argument for decision-makers. The Center of Disease Prevention and Control (CDPC) is the main institution responsible for collecting and summarizing all health-related data in Latvia.

The European Commission is supporting Latvia with projects in the areas of development of public sector innovation and digitalisation, including improving the use of health technology assessment in decision-making. This support has addressed a broad range of policy areas, including healthcare, better governance and public administration, and justice.

Latvia could still stand to increase the use of real-world healthcare data to inform biomedical research and evaluation. A “learning healthcare system” based on electronic health records and other routinely collected data holds large promises for facilitating medical research and improving effective and efficient use of medicines, is at an early stage in Latvia.

In conclusion, while Latvia has made strides in implementing RWE and RWD initiatives, there is still room for growth and development in this area. The country is actively participating in European-wide initiatives and projects to enhance the use of RWE and RWD in healthcare decision-making and is working towards a learning healthcare system that leverages these data sources.

Share this story...
UK – NICE – RWE Framework

October 14, 2023|2023, RWE 201|

RWE 201 - UK – NICE – RWE Framework  NICE RWE Framework: https://www.nice.org.uk/corporate/ecd9/chapter/overviewReal-world data (RWD) encompasses various types of information on patient health, care delivery, and experiences collected outside [...]

UK – MHRA – Randomised Controlled Trials Using Real World Data

October 14, 2023|2023, RWE 201|

RWE 201 - UK – MHRA – Randomised Controlled Trials Using Real World Data   MHRA RWD Guidance: https://www.gov.uk/government/publications/mhra-guidance-on-the-use-of-real-world-data-in-clinical-studies-to-support-regulatory-decisions/mhra-guideline-on-randomised-controlled-trials-using-real-world-data-to-support-regulatory-decisions The MHRA guideline focuses on sponsors planning to [...]

UK – MHRA – Use of RWD to Support Regulatory Decisions

October 14, 2023|2023, RWE 201|

RWE 201 - UK – MHRA – Use of RWD to Support Regulatory Decisions   MHRA RWD Guidance: https://www.gov.uk/government/publications/mhra-guidance-on-the-use-of-real-world-data-in-clinical-studies-to-support-regulatory-decisions/mhra-guidance-on-the-use-of-real-world-data-in-clinical-studies-to-support-regulatory-decisions The MHRA (Medicines and Healthcare products Regulatory Agency) [...]

Real World Evidence (RWE) 201 – France – Haute Autorité de Santé (HAS) – Real World Study Guide

September 4, 2023|2023, RWE 201|

RWE 201 - France – Haute Autorité de Santé (HAS) – Real World Study Guide  HAS Real World Stidy Guide: https://www.has-sante.fr/upload/docs/application/pdf/2021-06/real-world_studies_for_the_assessment_of_medicinal_products_and_medical_devices.pdfThe Haute Autorité de Santé (HAS), France's National Authority [...]