Incorporating real-life clinical data into drug development

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Project Title: Incorporating real-life clinical data into drug development
Project Number: CORDIS-203672
Project web address: Follow on CORDIS
Organization: Glaxosmithkline Research And Development Limited, United Kingdom, Stevenage
Collaborators: Bristol-Myers Squibb Company, US
University Of Manchester, GB
University Of Leicester, GB
University Of Bern, CH
London Sch/Hygiene &Tropical Medicine, GB
Janssen Pharmaceutica N.V., BE
Novo-Nordisk A/S, DK
Akademisch Ziekenhuis Groningen, NL
F. Hoffmann - La Roche Ltd., CH
European Organisation For Research & Treatment Of Cancer, BE
Eli Lilly Company Limited, GB
Merck Kommanditgesellschaft Auf Aktien, DE
Novartis Pharma Ag, CH
Astra Zeneca Ab, SE
Universitair Medisch Centrum Utrecht, NL
Bayer Pharma Ag, DE
Haute Autorite De Sante, FR
Panepistimio Ioanninon, GR
Sanofi-Aventis Recherche & Developpement, FR
Amgen Nv, BE
Takeda Development Centre Europe Ltd., GB
Boehriger Ingelheim International Gmbh, DE
European Medicines Agency, GB
La Sante Epidemiologie Evaluation Recherche Sarl (La-Ser), FR
International Alliance Of Patients' Organizations, GB
Merck Sharp And Dohme, Corp., US
National Institute For Health And Care Excellence, GB
Zorginstituut Nederland, NL
 
Project Description:
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
 
Project Terms:
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Project Title: Incorporating real-life clinical data into drug development
Project Number: CORDIS-203672
Project web address: Follow on CORDIS
Organization: Glaxosmithkline Research And Development Limited, United Kingdom, Stevenage
Collaborators: Bristol-Myers Squibb Company, US
University Of Manchester, GB
University Of Leicester, GB
University Of Bern, CH
London Sch/Hygiene &Tropical Medicine, GB
Janssen Pharmaceutica N.V., BE
Novo-Nordisk A/S, DK
Akademisch Ziekenhuis Groningen, NL
F. Hoffmann - La Roche Ltd., CH
European Organisation For Research & Treatment Of Cancer, BE
Eli Lilly Company Limited, GB
Merck Kommanditgesellschaft Auf Aktien, DE
Novartis Pharma Ag, CH
Astra Zeneca Ab, SE
Universitair Medisch Centrum Utrecht, NL
Bayer Pharma Ag, DE
Haute Autorite De Sante, FR
Panepistimio Ioanninon, GR
Sanofi-Aventis Recherche & Developpement, FR
Amgen Nv, BE
Takeda Development Centre Europe Ltd., GB
Boehriger Ingelheim International Gmbh, DE
European Medicines Agency, GB
La Sante Epidemiologie Evaluation Recherche Sarl (La-Ser), FR
International Alliance Of Patients' Organizations, GB
Merck Sharp And Dohme, Corp., US
National Institute For Health And Care Excellence, GB
Zorginstituut Nederland, NL
 
Project Categories:
Natural Sciences
 
Other Information:
Fiscal Year: 2013
Project Start Date: 1 October 2013
Project End Date: 31 December 2016
Project program: FP7-JTI
 
Project Funding Information:
Funding Mechanism: JTI-CP-IMI - Joint Technology Initiatives - Collaborative Project (IMI)
Year Funding Organization Total Funding, $
2013 European Research Council $18,079,961