Objetivo
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 (PASS, PAES, Reimbursement with Evidence Generation), and wide variability in access to medicines between countries.
The subsequent uncertainty relating to the reimbursement, and thus market implementation of new medication once approved by regulatory authorities, is negatively affecting the value of the drug development pipeline. The costly clinical developments to get to market approval, no longer seem to be a guarantee for market entry. This new risk presents a serious additional hurdle for drug developers that already face pipeline attrition. It also affects the speed and level of patient access, and therefore the extent to which patients and society might benefit from new medicines.
In recent years there has been considerable attention paid to the post-authorisation evaluation of treatments in real world clinical practice: study design and analytical methodology for assessing relative effectiveness; and use of registries and electronic healthcare data. It may be possible to improve the value of information available at initial market authorisation by incorporating these techniques into pre-authorisation drug development. HTA bodies, regulators, will become able to make better-informed decisions, and developers of new medicines will be able to direct development efforts to areas where value is most likely to be delivered to patients and health care systems, improving the efficiency of the whole medicine development chain.
However, the adoption of real world / relative effectiveness objectives in a pre-authorisation development strategy has many operational, methodological, regulatory, and ethical issues and Pharmaceutical R&D organisations need more certainty as to: the impact of development choices on the regulatory review process; the value of different programmes to HTA bodies and other decision makers; the best balance of pre-launch and post-launch effectiveness research and the coordination of various post-authorisation commitments. There is little guidance on how to incorporate alternative study designs into a development programme to optimally meet the needs of all stakeholders over time.
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 through:
• Bringing together regulators, HTA bodies, 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 modelling 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 programmes and use in the assessment of the value of new medicines;
• Sharing and discussing deliverables with, among others, Pharmaceutical companies, regulatory authorities, HTA / reimbursement agencies, clinicians and patient organizations;
• Developing trai
Ámbito científico
Convocatoria de propuestas
IMI-JU-07-2012
Consulte otros proyectos de esta convocatoria
Régimen de financiación
JTI-CP-IMI - Joint Technology Initiatives - Collaborative Project (IMI)Coordinador
TW89GS Brentford
Reino Unido
Ver en el mapa
Participantes (29)
3584 CX Utrecht
Ver en el mapa
1112 ZA DIEMEN
Ver en el mapa
LE1 7RH Leicester
Ver en el mapa
3012 Bern
Ver en el mapa
1200 Bruxelles / Brussel
Ver en el mapa
75015 Paris
Ver en el mapa
93218 Saint Denis La Plaine Cedex
Ver en el mapa
1083 HS Amsterdam
Ver en el mapa
La participación finalizó
SE1 7QY London
Ver en el mapa
La participación finalizó
WC1E 7HT London
Ver en el mapa
45110 Ioannina
Ver en el mapa
M1 4BT Manchester
Ver en el mapa
9713 GZ Groningen
Ver en el mapa
94250 GENTILLY
Ver en el mapa
RG21 4FA Basingstoke
Ver en el mapa
08889 Whitehouse Station Nj
Ver en el mapa
55218 Ingelheim
Ver en el mapa
2340 Beerse
Ver en el mapa
1831 Diegem
Ver en el mapa
10154 New York
Ver en el mapa
13353 Berlin
Ver en el mapa
151 85 Sodertaelje
Ver en el mapa
2880 Bagsvaerd
Ver en el mapa
4070 Basel
Ver en el mapa
4056 Basel
Ver en el mapa
64293 DARMSTADT
Ver en el mapa
WC2B 4AE London
Ver en el mapa
M13 9PL Manchester
Ver en el mapa
N1 6AH LONDON
Ver en el mapa