#	Pagina
attuale pagina	/open-h2020/projects/217798/results.html

Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - GetReal Initiative (The GetReal Initiative)

Teaser

Summary

The GetReal Initiative wants to drive the standards for quality and innovation in real-world evidence (RWE) generation as well as embed the use of RWE in decision-making within industry, regulatory authorities and Health Technology Assessments (HTA) agencies with the ultimate goal of improving use in routine clinical practice and patient outcomes. The project wants to foster the sustainable adoption of tools, methodologies and best practices from IMI GetReal. All activities are done in a multi-stakeholder approach, since this is the only way to increase the quality of RWE generation in medicine development and regulatory/HTA processes across Europe.

Work performed

WP1 â€“ Think Tank
During the past period, the Think Tank (TT) worked with consortium partners to define the TTâ€™s structure, purpose, and mandate. They also considered and defined the roles, responsibilities and benefits associated with different types of membership in the Think Tank. The working group members defined the vision and objectives for the TT and shortlisted European and International experts who were considered suitable for TT core membership. Between December 2018 and May 2019, they established the TT core-group, with 24 members. Two preparatory calls were scheduled ahead of the first face to face meeting of the TT core-group and agreed on an agenda for the first call.

WP1 â€“ Task Force A and C
The original Task Force A and Task Force C have been merged their activities to avoid duplication and simplify the interaction of the respective sub-tasks. In this report, they are jointly referred to as Task Force A.

Over the last year, multiple activities have been carried out. The work included, but is not limited to, a literature review, surveys with relevant stakeholders, and carrying out in-depth follow-up interviews. Also, an overview of real-world evidence designs has been compiled to create a context for when the choice of a pragmatic trial design is most appropriate. To gain initial insights into the value, use and future of the PragMagic tool, interviews have been conducted with GetReal Initiative members. Furthermore, it was identified that there is a need for a marketing plan and value-proposition for the tool. This is taken on in the second year of the project. Concurrently, a PragMagic tool validation is carried out.

To identify statistical challenges with a pragmatic study designs, the first phase of a literature review has been completed. A study protocol for a Delphi analysis has been written which sets out the method to be employed in developing best practice guidelines for statistical approaches for pragmatic trials. This will include two face-to-face meetings, three rounds of surveys and expert comments on a set of best practice recommendations. Industry and academic experts on the subject of statistical approaches for pragmatic trials were approached to take part in the Delphi analysis to develop Best Practice Recommendations. Twelve experts agreed to take part in the study: five from Industry and seven from academia.

WP1 â€“ Task Force B
Task Force B (TFB) focused its efforts on three main objectives: 1. Improvement of ADDIS regarding usability, stability and marketability; 2. Education and outreach to promote knowledge and usage of ADDIS and NMA in general and 3. Working with our partners to identify the main requirements and avenues for ADDIS to begin generating revenue.
The documentation and process of deploying the software were greatly streamlined, and deployment documentation and guidance were also improved. Also, support for EUdraCT XML format has been added, as this is a great selling point for companies participating in the European regulatory process.
The Task Force gave several workshops for the Dutch Medicine Evaluation Board throughout year 1, as well as a workshop at the 34th International Conference on Pharmacoepidemiology (ICPE). Also, they organized two webinars about network meta-analysis in general, and how to perform an Network Meta-Analysis in ADDIS specifically.

WP2
The work package has focused on achieving milestones to ensure the long-term sustainability of the project. They have conducted market research to understand the environment/opportunities for sustainability after the course of the project. As part of this research, the likely funding streams and organisational models of other existing not-for-profit organisations have been mapped out and summarised. Furthermore, they proposed a strategy to achieve this sustainability. Lastly, WP2 developed the first draft version of the business plan and shared it with the consortium during the Annual Meeting.

WP3
Work p

Final results

The GetReal Initiative will enable interaction and research partnership on science and innovation in RWE involving regulators, HTA bodies, academia, patients, physicians and industry. This will facilitate researchers from across all sectors of the healthcare ecosystem to come together around key challenges facing the generation of RWE and its adoption into drug development, regulatory and HTA decision making as well as physician and patient treatment decisions. This level of multi-stakeholder partnership is unique and will be fundamental to creating solutions that are supported by, and of value to, each of the individual stakeholder groups. Through partnering with other organisations, the GetReal Initiative will play a prominent role in increasing the quality and standard of RWE research as well as bringing understanding and transparency to the methodologies used.

Our future business plan will translate this partnership into a sustainable platform. On the long term, by improving the quality and increasing the utilisation of Real World Data and Real World Evidence early in medicines development, the tools and methodological approaches established by the GetReal Initiative will offer the opportunity to increase efficiency and decrease the costs of drug development.