Pichler get real at ht ai- introduction
1 like1,989 views
This document discusses research supported by the Innovative Medicines Initiative Joint Undertaking to develop methods for incorporating real-world clinical data into drug development strategies earlier in the process. The research is conducted by a partnership between universities, research organizations, companies, and other groups. The goal is to address demands from health technology assessment bodies and payers for evidence of a drug's effectiveness in real-world settings prior to approval, to better inform reimbursement and pricing decisions. Several work packages are developing methods like clinical trial simulations, pragmatic trial designs, using real-world data to supplement randomized controlled trial results, and evidence synthesis techniques.
![The research leading to these results has received support from the Innovative Medicines Initiative Joint Undertaking under grant
agreement no [115303], resources of which are composed of financial contribution from the European Union’s Seventh Framework
Programme (FP7/2007-2013) and EFPIA companies’ in kind contribution.
www.imi.europa.eu
INCORPORATING REAL-LIFE
CLINICAL DATA INTO DEVELOPMENT
STRATEGIES](https://image.slidesharecdn.com/pichlergetrealathtai-introduction-150619143118-lva1-app6892/85/Pichler-get-real-at-ht-ai-introduction-1-320.jpg)
![The research leading to these results has received support from the Innovative Medicines Initiative Joint Undertaking under grant
agreement no [115303], resources of which are composed of financial contribution from the European Union’s Seventh Framework
Programme (FP7/2007-2013) and EFPIA companies’ in kind contribution.
www.imi.europa.eu
IMI – Public-Private
Partnership
Nat Med 2014;20:5.](https://image.slidesharecdn.com/pichlergetrealathtai-introduction-150619143118-lva1-app6892/85/Pichler-get-real-at-ht-ai-introduction-2-320.jpg)
![The research leading to these results has received support from the Innovative Medicines Initiative Joint Undertaking under grant
agreement no [115303], resources of which are composed of financial contribution from the European Union’s Seventh Framework
Programme (FP7/2007-2013) and EFPIA companies’ in kind contribution.
www.imi.europa.eu
Universities, research organisations, public bodies, non-profit groups
Universitair Medisch Centrum Utrecht, the Netherlands
Academisch Ziekenhuis Groningen, the Netherlands
Zorginstituut Nederland, the Netherlands
European Medicines Agency, UK
European Organisation for Research and Treatment of Cancer, Belgium
Haute Autorité de Santé, France
University of Manchester, 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
Patients’ organisations
International Alliance of Patients' Organizations, UK
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
EFPIA companies
GetReal Partners](https://image.slidesharecdn.com/pichlergetrealathtai-introduction-150619143118-lva1-app6892/85/Pichler-get-real-at-ht-ai-introduction-3-320.jpg)
![The research leading to these results has received support from the Innovative Medicines Initiative Joint Undertaking under grant
agreement no [115303], resources of which are composed of financial contribution from the European Union’s Seventh Framework
Programme (FP7/2007-2013) and EFPIA companies’ in kind contribution.
www.imi.europa.eu
Introduction
HTAi 2015](https://image.slidesharecdn.com/pichlergetrealathtai-introduction-150619143118-lva1-app6892/85/Pichler-get-real-at-ht-ai-introduction-4-320.jpg)
![The research leading to these results has received support from the Innovative Medicines Initiative Joint Undertaking under grant
agreement no [115303], resources of which are composed of financial contribution from the European Union’s Seventh Framework
Programme (FP7/2007-2013) and EFPIA companies’ in kind contribution.
www.imi.europa.eu
Introduction
What is driving the need for effectiveness at launch?
• Currently: efficacy at launch is the prime source for HTA, some epidemiology and
economic data is used for assumptions for budget impact and c/e models where
required; but effectiveness studies are considered for post-launch.
• This paradigm is under pressure as decision-makers respond to budget constraints by
aiming to identify the ‘right place’ for new treatments. Ideally this is will be informed by
a better understanding of value rather than through cost containment.
• Emerging focus on how best to understand real-world effectiveness pre launch not just
post launch
– R&D companies are willing to consider generating more information pre launch
– Regulators/HTA bodies are willing explore how evidence is used in decision-
making.
• Options?
– More informative trials; phase 3 designs and new 3b studies
– Better methods of evidence synthesis; more robust integration of results from
efficacy studies and real world data
• BUT Uncertainty in R&D decision-making is affecting uptake of new approaches](https://image.slidesharecdn.com/pichlergetrealathtai-introduction-150619143118-lva1-app6892/85/Pichler-get-real-at-ht-ai-introduction-5-320.jpg)
![The research leading to these results has received support from the Innovative Medicines Initiative Joint Undertaking under grant
agreement no [115303], resources of which are composed of financial contribution from the European Union’s Seventh Framework
Programme (FP7/2007-2013) and EFPIA companies’ in kind contribution.
www.imi.europa.eu
Background
RWE on
disease,
treatments,
care pathways,
unmet need
etc
Post Launch
RWE on: use of
new medicine,
relative
effectiveness,
longer term
outcomes
Potential Value Confirm Value
Comparative Trials. Pragmatic Trials, giving
information on effectiveness
More Focussed Context for current care and
outcomes to inform initial assessments
Evidence Synthesis to combine all sources of
information: RCT + PCT + OBS
Predict Value of new Medicine
How much can be done pre-launch?
Or should we get to Post-Launch sooner?
Before phase3 During phase3 After Launch](https://image.slidesharecdn.com/pichlergetrealathtai-introduction-150619143118-lva1-app6892/85/Pichler-get-real-at-ht-ai-introduction-6-320.jpg)
![The research leading to these results has received support from the Innovative Medicines Initiative Joint Undertaking under grant
agreement no [115303], resources of which are composed of financial contribution from the European Union’s Seventh Framework
Programme (FP7/2007-2013) and EFPIA companies’ in kind contribution.
www.imi.europa.eu
R&D Decision Making
Needs?
Feasibility & Cost?
Acceptability?
Other Portfolio?
HTA Decision Making
Gaps?
Scientific Validity?
Acceptability?
Other?
Scientific Advice
Needs?
Feasibility?
Acceptability?
Other?
Submission
Relative Efficacy or
Effectiveness?
Gaps and plans?](https://image.slidesharecdn.com/pichlergetrealathtai-introduction-150619143118-lva1-app6892/85/Pichler-get-real-at-ht-ai-introduction-7-320.jpg)
![The research leading to these results has received support from the Innovative Medicines Initiative Joint Undertaking under grant
agreement no [115303], resources of which are composed of financial contribution from the European Union’s Seventh Framework
Programme (FP7/2007-2013) and EFPIA companies’ in kind contribution.
www.imi.europa.eu
WP1
Acceptability
Decision
Frameworks
Policy Agenda
WP2
Understanding the
efficacy-effectiveness
gap
simulation of trials to
improve design
WP3
Overcoming
practical barriers to
running real-world
studies pre launch
WP4
Identifying best
practice and creating
new methods for
evidence synthesis and
predictive modellingScientific Dissemination
Useful Tools
Slide 8
R&D decisions on development
HTA Guidance and Acceptability
Joint Scientific Advice
MAPPS
Training and Education](https://image.slidesharecdn.com/pichlergetrealathtai-introduction-150619143118-lva1-app6892/85/Pichler-get-real-at-ht-ai-introduction-8-320.jpg)
![The research leading to these results has received support from the Innovative Medicines Initiative Joint Undertaking under grant
agreement no [115303], resources of which are composed of financial contribution from the European Union’s Seventh Framework
Programme (FP7/2007-2013) and EFPIA companies’ in kind contribution.
www.imi.europa.eu
WP1 Case Study
Projects
Case study Challenge/Method Lead
Multiple
Sclerosis
Network Meta Analysis including RWD: comparative data
Trial simulation and risk stratification
NICE
Novartis
Metastatic
Melanoma
Generalising from trials using registry (RWD) data.
Value of non-traditional data and patient perspective
Trial Populations; Comparators; QoL Measurement
ZIN
BMS
NSCLC Propensity weighting methods using RWE to re-weight trial data -
generalisability
ULeic
Lilly
Rheumatoid
Arthritis
Network Meta Analysis including RWD: comparative data
Treatment sequencing
ULeic
Amgen
Diabetes
(TBC)
Indirect comparison, comparative data
Pragmatic trial design with dose escalation,
Value of patient collected data; outcome measures
NICE
Novo
COPD Pragmatic controlled trials: efficacy vs effectiveness NICE
GSK
IMI GetReal Mid-term Review 09Jun15
WP1 Summary Slide 9](https://image.slidesharecdn.com/pichlergetrealathtai-introduction-150619143118-lva1-app6892/85/Pichler-get-real-at-ht-ai-introduction-9-320.jpg)
![The research leading to these results has received support from the Innovative Medicines Initiative Joint Undertaking under grant
agreement no [115303], resources of which are composed of financial contribution from the European Union’s Seventh Framework
Programme (FP7/2007-2013) and EFPIA companies’ in kind contribution.
www.imi.europa.eu
• Identification of drivers of effectiveness (case studies & SLR)
– Antipsychotic drugs in SCZ patients
– Anticoagulant drugs
– Anti-hypertensive drugs
– Anti-diabetes drugs
– Hodgkin’s lymphoma
WP2 Case Study Projects
• Assessment of design parameters and analytical tools to be
used in pre-launch trials / pragmatic trials (simulation
studies)
– Pragmatic trials (TwiCS cohort design, cluster-randomized trials)
– Pre-launch RCTs: how to mitigate between the need for homogeneous
population and more “representative” trial samples](https://image.slidesharecdn.com/pichlergetrealathtai-introduction-150619143118-lva1-app6892/85/Pichler-get-real-at-ht-ai-introduction-10-320.jpg)
![The research leading to these results has received support from the Innovative Medicines Initiative Joint Undertaking under grant
agreement no [115303], resources of which are composed of financial contribution from the European Union’s Seventh Framework
Programme (FP7/2007-2013) and EFPIA companies’ in kind contribution.
www.imi.europa.eu
WP2 teams
Teams
Team 1
Lead: LASER, Sanofi
Participation: Takeda, AstraZeneca and Lilly
Team 2
Lead: UMCU and Novo-Nordisk
Participation: Merck
Team 3
Lead: EORTC and Sanofi
Participation: BMS
Team 4
Lead: UniMan
Participation: Sanofi, Novartis, Merck
Team 5
Lead: HAS
Participation: Amgen](https://image.slidesharecdn.com/pichlergetrealathtai-introduction-150619143118-lva1-app6892/85/Pichler-get-real-at-ht-ai-introduction-11-320.jpg)
![The research leading to these results has received support from the Innovative Medicines Initiative Joint Undertaking under grant
agreement no [115303], resources of which are composed of financial contribution from the European Union’s Seventh Framework
Programme (FP7/2007-2013) and EFPIA companies’ in kind contribution.
www.imi.europa.eu
WP3 Leads: UMCU; Lilly](https://image.slidesharecdn.com/pichlergetrealathtai-introduction-150619143118-lva1-app6892/85/Pichler-get-real-at-ht-ai-introduction-12-320.jpg)
![The research leading to these results has received support from the Innovative Medicines Initiative Joint Undertaking under grant
agreement no [115303], resources of which are composed of financial contribution from the European Union’s Seventh Framework
Programme (FP7/2007-2013) and EFPIA companies’ in kind contribution.
www.imi.europa.eu
Team Academic Lead(s) Industry Lead(s)
Case Study: Schizophrenia University of Ioannina Lilly
Case Study: Depression University Medical Center
Utrecht
MSD
Case Study: Rheumatoid
Arthritis
University of Bern Roche, Amgen, Janssen
Case Study: Cancer
(Hogkin’s Lymphoma)
University of Bern, EORTC Roche
Software Development University Medical Centre
Groningen
Amgen, Lilly
Introducing WP4 - Teams
13](https://image.slidesharecdn.com/pichlergetrealathtai-introduction-150619143118-lva1-app6892/85/Pichler-get-real-at-ht-ai-introduction-13-320.jpg)
![The research leading to these results has received support from the Innovative Medicines Initiative Joint Undertaking under grant
agreement no [115303], resources of which are composed of financial contribution from the European Union’s Seventh Framework
Programme (FP7/2007-2013) and EFPIA companies’ in kind contribution.
www.imi.europa.eu
Team Academic Lead(s)
Case Study:
Schizophrenia
assess existing methodology and develop new methods for
combining IPD and AD from randomized trials as well as IPD from
observational studies in a network meta-analysis
Case Study:
Depression
describe and compare approaches for individual-level
patient data meta-analysis (IPD-MA) of multiple treatments
Case Study:
Rheumatoid Arthritis
Assessment of efficacy-effectiveness gaps,
Combination of results from different study and data types,
and use of mathematical modelling to predict real-world
effectivenessCase Study: Cancer
(Hogkin’s Lymphoma)
Software Development ADDIS-2
14
WP2 Case Study Projects](https://image.slidesharecdn.com/pichlergetrealathtai-introduction-150619143118-lva1-app6892/85/Pichler-get-real-at-ht-ai-introduction-14-320.jpg)
![The research leading to these results has received support from the Innovative Medicines Initiative Joint Undertaking under grant
agreement no [115303], resources of which are composed of financial contribution from the European Union’s Seventh Framework
Programme (FP7/2007-2013) and EFPIA companies’ in kind contribution.
www.imi.europa.eu
R&D Decision Making
Needs?
Feasibility & Cost?
Acceptability?
Other Portfolio?
HTA Decision Making
Gaps?
Scientific Validity?
Acceptability?
Other?
Scientific Advice
Needs?
Feasibility?
Acceptability?
Other?
Submission
Relative Efficacy or
Effectiveness?
Gaps and plans?
Adopt GetReal framework, methodology and tools in:
Emerging Scientific Advice Processes
Emerging REA at market Authorisation and National HTA
MAPPS
Disease specific IMI2 projects
Training and Education Programmes
R&D drug Development processes
SUSTAINABILITY](https://image.slidesharecdn.com/pichlergetrealathtai-introduction-150619143118-lva1-app6892/85/Pichler-get-real-at-ht-ai-introduction-15-320.jpg)
Pichler get real at ht ai- introduction
- 1. The research leading to these results has received support from the Innovative Medicines Initiative Joint Undertaking under grant agreement no [115303], resources of which are composed of financial contribution from the European Union’s Seventh Framework Programme (FP7/2007-2013) and EFPIA companies’ in kind contribution. www.imi.europa.eu INCORPORATING REAL-LIFE CLINICAL DATA INTO DEVELOPMENT STRATEGIES
- 2. The research leading to these results has received support from the Innovative Medicines Initiative Joint Undertaking under grant agreement no [115303], resources of which are composed of financial contribution from the European Union’s Seventh Framework Programme (FP7/2007-2013) and EFPIA companies’ in kind contribution. www.imi.europa.eu IMI – Public-Private Partnership Nat Med 2014;20:5.
- 3. The research leading to these results has received support from the Innovative Medicines Initiative Joint Undertaking under grant agreement no [115303], resources of which are composed of financial contribution from the European Union’s Seventh Framework Programme (FP7/2007-2013) and EFPIA companies’ in kind contribution. www.imi.europa.eu Universities, research organisations, public bodies, non-profit groups Universitair Medisch Centrum Utrecht, the Netherlands Academisch Ziekenhuis Groningen, the Netherlands Zorginstituut Nederland, the Netherlands European Medicines Agency, UK European Organisation for Research and Treatment of Cancer, Belgium Haute Autorité de Santé, France University of Manchester, 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 Patients’ organisations International Alliance of Patients' Organizations, UK 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 EFPIA companies GetReal Partners
- 4. The research leading to these results has received support from the Innovative Medicines Initiative Joint Undertaking under grant agreement no [115303], resources of which are composed of financial contribution from the European Union’s Seventh Framework Programme (FP7/2007-2013) and EFPIA companies’ in kind contribution. www.imi.europa.eu Introduction HTAi 2015
- 5. The research leading to these results has received support from the Innovative Medicines Initiative Joint Undertaking under grant agreement no [115303], resources of which are composed of financial contribution from the European Union’s Seventh Framework Programme (FP7/2007-2013) and EFPIA companies’ in kind contribution. www.imi.europa.eu Introduction What is driving the need for effectiveness at launch? • Currently: efficacy at launch is the prime source for HTA, some epidemiology and economic data is used for assumptions for budget impact and c/e models where required; but effectiveness studies are considered for post-launch. • This paradigm is under pressure as decision-makers respond to budget constraints by aiming to identify the ‘right place’ for new treatments. Ideally this is will be informed by a better understanding of value rather than through cost containment. • Emerging focus on how best to understand real-world effectiveness pre launch not just post launch – R&D companies are willing to consider generating more information pre launch – Regulators/HTA bodies are willing explore how evidence is used in decision- making. • Options? – More informative trials; phase 3 designs and new 3b studies – Better methods of evidence synthesis; more robust integration of results from efficacy studies and real world data • BUT Uncertainty in R&D decision-making is affecting uptake of new approaches
- 6. The research leading to these results has received support from the Innovative Medicines Initiative Joint Undertaking under grant agreement no [115303], resources of which are composed of financial contribution from the European Union’s Seventh Framework Programme (FP7/2007-2013) and EFPIA companies’ in kind contribution. www.imi.europa.eu Background RWE on disease, treatments, care pathways, unmet need etc Post Launch RWE on: use of new medicine, relative effectiveness, longer term outcomes Potential Value Confirm Value Comparative Trials. Pragmatic Trials, giving information on effectiveness More Focussed Context for current care and outcomes to inform initial assessments Evidence Synthesis to combine all sources of information: RCT + PCT + OBS Predict Value of new Medicine How much can be done pre-launch? Or should we get to Post-Launch sooner? Before phase3 During phase3 After Launch
- 7. The research leading to these results has received support from the Innovative Medicines Initiative Joint Undertaking under grant agreement no [115303], resources of which are composed of financial contribution from the European Union’s Seventh Framework Programme (FP7/2007-2013) and EFPIA companies’ in kind contribution. www.imi.europa.eu R&D Decision Making Needs? Feasibility & Cost? Acceptability? Other Portfolio? HTA Decision Making Gaps? Scientific Validity? Acceptability? Other? Scientific Advice Needs? Feasibility? Acceptability? Other? Submission Relative Efficacy or Effectiveness? Gaps and plans?
- 8. The research leading to these results has received support from the Innovative Medicines Initiative Joint Undertaking under grant agreement no [115303], resources of which are composed of financial contribution from the European Union’s Seventh Framework Programme (FP7/2007-2013) and EFPIA companies’ in kind contribution. www.imi.europa.eu WP1 Acceptability Decision Frameworks Policy Agenda WP2 Understanding the efficacy-effectiveness gap simulation of trials to improve design WP3 Overcoming practical barriers to running real-world studies pre launch WP4 Identifying best practice and creating new methods for evidence synthesis and predictive modellingScientific Dissemination Useful Tools Slide 8 R&D decisions on development HTA Guidance and Acceptability Joint Scientific Advice MAPPS Training and Education
- 9. The research leading to these results has received support from the Innovative Medicines Initiative Joint Undertaking under grant agreement no [115303], resources of which are composed of financial contribution from the European Union’s Seventh Framework Programme (FP7/2007-2013) and EFPIA companies’ in kind contribution. www.imi.europa.eu WP1 Case Study Projects Case study Challenge/Method Lead Multiple Sclerosis Network Meta Analysis including RWD: comparative data Trial simulation and risk stratification NICE Novartis Metastatic Melanoma Generalising from trials using registry (RWD) data. Value of non-traditional data and patient perspective Trial Populations; Comparators; QoL Measurement ZIN BMS NSCLC Propensity weighting methods using RWE to re-weight trial data - generalisability ULeic Lilly Rheumatoid Arthritis Network Meta Analysis including RWD: comparative data Treatment sequencing ULeic Amgen Diabetes (TBC) Indirect comparison, comparative data Pragmatic trial design with dose escalation, Value of patient collected data; outcome measures NICE Novo COPD Pragmatic controlled trials: efficacy vs effectiveness NICE GSK IMI GetReal Mid-term Review 09Jun15 WP1 Summary Slide 9
- 10. The research leading to these results has received support from the Innovative Medicines Initiative Joint Undertaking under grant agreement no [115303], resources of which are composed of financial contribution from the European Union’s Seventh Framework Programme (FP7/2007-2013) and EFPIA companies’ in kind contribution. www.imi.europa.eu • Identification of drivers of effectiveness (case studies & SLR) – Antipsychotic drugs in SCZ patients – Anticoagulant drugs – Anti-hypertensive drugs – Anti-diabetes drugs – Hodgkin’s lymphoma WP2 Case Study Projects • Assessment of design parameters and analytical tools to be used in pre-launch trials / pragmatic trials (simulation studies) – Pragmatic trials (TwiCS cohort design, cluster-randomized trials) – Pre-launch RCTs: how to mitigate between the need for homogeneous population and more “representative” trial samples
- 11. The research leading to these results has received support from the Innovative Medicines Initiative Joint Undertaking under grant agreement no [115303], resources of which are composed of financial contribution from the European Union’s Seventh Framework Programme (FP7/2007-2013) and EFPIA companies’ in kind contribution. www.imi.europa.eu WP2 teams Teams Team 1 Lead: LASER, Sanofi Participation: Takeda, AstraZeneca and Lilly Team 2 Lead: UMCU and Novo-Nordisk Participation: Merck Team 3 Lead: EORTC and Sanofi Participation: BMS Team 4 Lead: UniMan Participation: Sanofi, Novartis, Merck Team 5 Lead: HAS Participation: Amgen
- 12. The research leading to these results has received support from the Innovative Medicines Initiative Joint Undertaking under grant agreement no [115303], resources of which are composed of financial contribution from the European Union’s Seventh Framework Programme (FP7/2007-2013) and EFPIA companies’ in kind contribution. www.imi.europa.eu WP3 Leads: UMCU; Lilly
- 13. The research leading to these results has received support from the Innovative Medicines Initiative Joint Undertaking under grant agreement no [115303], resources of which are composed of financial contribution from the European Union’s Seventh Framework Programme (FP7/2007-2013) and EFPIA companies’ in kind contribution. www.imi.europa.eu Team Academic Lead(s) Industry Lead(s) Case Study: Schizophrenia University of Ioannina Lilly Case Study: Depression University Medical Center Utrecht MSD Case Study: Rheumatoid Arthritis University of Bern Roche, Amgen, Janssen Case Study: Cancer (Hogkin’s Lymphoma) University of Bern, EORTC Roche Software Development University Medical Centre Groningen Amgen, Lilly Introducing WP4 - Teams 13
- 14. The research leading to these results has received support from the Innovative Medicines Initiative Joint Undertaking under grant agreement no [115303], resources of which are composed of financial contribution from the European Union’s Seventh Framework Programme (FP7/2007-2013) and EFPIA companies’ in kind contribution. www.imi.europa.eu Team Academic Lead(s) Case Study: Schizophrenia assess existing methodology and develop new methods for combining IPD and AD from randomized trials as well as IPD from observational studies in a network meta-analysis Case Study: Depression describe and compare approaches for individual-level patient data meta-analysis (IPD-MA) of multiple treatments Case Study: Rheumatoid Arthritis Assessment of efficacy-effectiveness gaps, Combination of results from different study and data types, and use of mathematical modelling to predict real-world effectivenessCase Study: Cancer (Hogkin’s Lymphoma) Software Development ADDIS-2 14 WP2 Case Study Projects
- 15. The research leading to these results has received support from the Innovative Medicines Initiative Joint Undertaking under grant agreement no [115303], resources of which are composed of financial contribution from the European Union’s Seventh Framework Programme (FP7/2007-2013) and EFPIA companies’ in kind contribution. www.imi.europa.eu R&D Decision Making Needs? Feasibility & Cost? Acceptability? Other Portfolio? HTA Decision Making Gaps? Scientific Validity? Acceptability? Other? Scientific Advice Needs? Feasibility? Acceptability? Other? Submission Relative Efficacy or Effectiveness? Gaps and plans? Adopt GetReal framework, methodology and tools in: Emerging Scientific Advice Processes Emerging REA at market Authorisation and National HTA MAPPS Disease specific IMI2 projects Training and Education Programmes R&D drug Development processes SUSTAINABILITY