BRUSSELS, Belgium—The Innovative Medicines Initiative (IMI) has launched a new project called GetReal that will investigate new ways of integrating data from real life settings, such as clinics, into drug development. The goal is to assist healthcare decision makers when deciding how best to grant patients access to a new treatment and help pharmaceutical companies to make better decisions during drug development.
The GetReal consortium aims to improve the efficiency of the medicine development process by better incorporating estimates of relative effectiveness into drug development and to enrich decision-making by regulatory authorities and Health Technology Assessment (HTA) bodies through practices such as: Bringing together regulators, HTA bodies, academics, companies, patients and other societal stakeholders; assessing existing processes, methodologies, and key research issues; proposing innovative (and more pragmatic) trial designs and assessing the value of information; proposing and testing innovative analytical and predictive modeling approaches; assessing operational, ethical, regulatory issues and proposing and testing solutions; creating new decision-making frameworks and building open tools to allow for the evaluation of development programs and use in the assessment of the value of new medicines; sharing and discussing deliverables with, among others, pharmaceutical companies, regulatory authorities, HTA and reimbursement agencies, clinicians and patient organizations; and developing training activities for researchers, decision makers and societal stakeholders in the public and private sector in order to increase knowledge about various aspects of relative effectiveness.
In Europe, once a new drug has been developed, it must be reviewed by both the marketing authorization and HTA bodies. HTA organizations assess the drug’s ‘relative effectiveness,’ which is the extent to which a treatment does more good than harm when compared to one or more alternative treatments provided under normal healthcare circumstances.
Ideally, HTA organizations need data from real-life settings, yet there is little guidance on how to generate real-world data and integrate this into drug development before launch, notes the press statement from IMI introducing the GetReal program. This is a serious issue since insufficient evidence supporting relative effectiveness may delay or restrict patient access to new treatments. The challenge, therefore, is to incorporate innovative study designs into the earlier stages of drug research and development to ensure both regulators and HTA bodies get the data they need. This is where the GetReal project comes in.
The project aims to bring together for the first time all key stakeholders (industry, academia, regulatory agencies, health technology assessment bodies, healthcare budget holders, and patient groups) to share their perspectives and insights on how relative effectiveness can best be assessed in HTA decision-making processes, and so will pave the way for advancing the development of new approaches for incorporating real-life data into drug development.
Working together, these diverse partners (see sidebar, below) will analyze existing processes and methodologies for HTA. GetReal will also generate a decision-making framework to help pharmaceutical companies design drug development strategies. A significant part of the project is devoted to organizing training activities for researchers, healthcare decision makers and other stakeholders on relative effectiveness concepts and how they can be applied.
IMI Executive Director Michel Goldman said:”Collaboration between these diverse groups can be sensitive. By bringing them together in the safe harbor offered by IMI, GetReal is in a unique position to reach a greater consensus on these issues to improve the efficiency of R&D and the decision-making processes.”
GlaxoSmithKline Research and Development Ltd, UK
Amgen NV/SA, Belgium
AstraZeneca AB, Sweden
Bayer Pharma AG, Germany
Boehringer Ingelheim International GmbH, Germany
Bristol Myers Squibb EMEA sarl, US
Eli Lilly, UK
F. Hoffmann-La Roche AG, Switzerland
Janssen Pharmaceutica NV, Belgium
Merck KGaA, Germany
Merck Sharp & Dohme Corp., US
Novartis Pharma AG, Switzerland
Novo Nordisk A/S, Denmark
Sanofi-Aventis Research and Development, France
Takeda Development Centre Europe Ltd, UK
Universities, research organisations, public bodies, non-profit groups:
University Medical Center Utrecht, the Netherlands
University Medical Center Groningen, the Netherlands
College voor Zorgverzekeringen, the Netherlands
European Medicines Agency, UK
European Organisation for Research and Treatment of Cancer, Belgium
Haute Autorité de Santé, France
London School of Hygiene and Tropical Medicine, UK
National Institute for Health and Care Excellence, UK
Panepistimio Ioanninon, Greece
Universität Bern, Switzerland
University of Leicester, UK
Small and medium-sized enterprises (SMEs):
LA Santé Epidemiologie Evaluation et Recherche, France
International Alliance of Patients' Organizations, UK
Diederick E. Grobbee
The Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht