Our current work on ADDIS is part of the GetReal Initiative project. The initial creation of ADDIS was funded by IMI GetReal. The ADDIS Desktop project was funded by TI Pharma’s Escher project. Additional funding for the further development of the MCDA user interface was received from the IMI PROTECT project.
GetReal Initiative (IMI, 2018-2020)
Launched in June 2018, the GetReal Initiative is a two-year project of the Innovative Medicines Initiative (IMI), a EU public-private consortium consisting of pharmaceutical companies, academia, HTA agencies and regulators, patient organisations and SMEs.
The GetReal Initiative brings together partners from the original IMI GetReal project with the ultimate goal to sustainably drive the adoption of tools, methodologies and best practices from IMI GetReal and increase the quality of real-world evidence (RWE) generation in medicines development and regulatory/HTA processes across Europe.
GetReal (IMI, 2013 - 2017)
Incorporating real-life clinical data into drug development
When a new medicine reaches the market, it is accompanied by an extensive data package that provides information about the safety and efficacy of the medicine in a clinical trial setting. However, assessing the expected future value of the medicines when used in “real world” clinical practice requires additional information next to traditional (pre-authorisation) clinical trials. Regulatory, HTA agencies and other healthcare decision makers have to make decisions on authorisation and access under conditions of uncertainty. Currently, data packages which aim to minimise uncertainty on safety and efficacy may leave significant uncertainty in assessments of real world effectiveness of new medicines. This results in further research commitments required post-authorisation, and wide variability in access to medicines between countries.
The GetReal consortium aims to improve the efficiency of the medicine development process by better incorporating real-life clinical data into drug development and to enrich decision-making by regulatory authorities and HTA bodies. GetReal is a public-private partnership between key European stakeholders and leading research groups. These include the EMA, the Dutch reimbursement body CvZ that is a member of the EUnetHTA network in which the various reimbursement bodies throughout Europe are bundling their expertise on Health Technology Assessment, and the International Alliance of Patients’ Organizations (IAPO) that covers patient organizations all over the world. GetReal creates impact by developing a set of tools, decision frameworks, methods and insights to include real clinical data in drug development.
The ADDIS project is part of work package 4, promoting best practice in evidence synthesis and predictive modelling of relative effectiveness. Methodological issues to be addressed focus on the combination of data from the mix of randomised and observational studies that are typically available at the launch of a new medicine. We will develop and promote user-friendly software to support evidence synthesis and predictive modelling of pharmaceutical therapies.
Escher Project (TI Pharma, 2008 - 2013)
Science-driven drug regulation
Our work on ADDIS Desktop was funded by the Dutch Top Institute Pharma, specifically through the Escher Project workpackage 3.2. The goal of the Escher project was to “engergize pharmaceutical R&D by identifying, evaluating and removing regulatory barriers to bring effacious and safe medicines to patients in an efficient and timely fashion.”
In workpackage 3.2, we created evidence-based drug information repositories in which drug efficacy and safety questions can be answered in an efficient, transparent and accountable way. Comparisons within and across medicinal products can now be made in a more automated and, hence, more efficient way.
The following resources were funded by Escher WP 3.2:
- Dr. Tommi Tervonen, post-doc researcher (2008-09 - 2010-08)
- Gert van Valkenhoef, PhD student (2009-04 - 2012-12)
- Software development (1-3 part-time developers, 2009-10 - 2013-06)
Through the commissioned project “industry requirements and a data standard for ADDIS”
- Hans van Leeuwen
- Prof. dr. Jozef Aerts
Through the commissioned project “decision support for benefit-risk assessment with imprecise preference information”
- Dr. Gert van Valkenhoef, post-doc researcher (2013-01 - 2013-06)