a paradigm shift in clinical trials
TRANSCRIPT
INTERNATIONAL CONFERENCE
European Clinical Trial day, the future of clinicalresearch: is the 536/14 regulation enough?
Regulatory Authorities, Ethic Committees, Sponsors, Researchers, Sites and Patients
A Paradigm Shift in Clinical Trials
Prof. Claude Farrugia, President EIPG 13th October 2017
Milan, Palazzo Lombardia
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Final selection compound
Phase Ia40‐60 healthy
subjects$300,0006 months
Phase Ib30‐50 healthy
subjects$300,000
6 months – 1 year
Phase IIa50‐200 patients$750,000
9 months – 2 years
Phase IIb200‐500 patients$3,500,0002‐3 years
Phase III 500‐1000+ patients
$6,000,0002‐5+ years
Phase IV 10000+ patients
$10,000,000+2‐4+ years
Early clinical development(Exploratory)
Full development(Confirmatory)
Launch(Obligatory)
A look to the past..
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“The Committee’s decided to ban further researchuntil it can be proven your ‘wheel’ poses no
threat to the environment, society or public health”
…and its precautionary principle
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The winds of changeMore clinical trials registered
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The winds of changeChanges in NAS characteristics over time
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The winds of changeChanges in NAS characteristics over time
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The winds of changeChanges in NAS characteristics over time
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The winds of changeChanges in NAS characteristics over time
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The winds of changeChanges in NAS characteristics over time
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The winds of changeChanges in NAS characteristics over time
Source: Morrison C., Lähteenmäki R., 2017. Public biotech in 2016—the numbers. Nature Biotechnology 35, 623‐629.
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The winds of changeGlobal medicines in late stage
development in 2016
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Some things don’t changeClinical trials are still the main
contributor to R&D cost
Source: DiMasi J.A., Grabowski H.G., Hansen, R.W., 2016. Innovation in the pharmaceutical industry: New estimates of R&D costs. Journal of Health Economics 47, 20‐33.
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Some things don’t changeClinical trials are still the main
contributor to R&D cost
Source: DiMasi J.A., Grabowski H.G., Hansen, R.W., 2016. Innovation in the pharmaceutical industry: New estimates of R&D costs. Journal of Health Economics 47, 20‐33.
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Some things don’t changeClinical trials are still the main
contributor to R&D cost
Source: DiMasi J.A., Grabowski H.G., Hansen, R.W., 2016. Innovation in the pharmaceutical industry: New estimates of R&D costs. Journal of Health Economics 47, 20‐33.
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Some things don’t changeSuccess is rewarding but failure is costly
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Some things don’t changeSuccess is rewarding but failure is costly
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Some things don’t changeSuccess is rewarding but failure is costly
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Headwinds of changeDrug development is getting costlier
Source: DiMasi J.A., Grabowski H.G., Hansen, R.W., 2016. Innovation in the pharmaceutical industry: New estimates of R&D costs. Journal of Health Economics 47, 20‐33.
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Headwinds of changeAverage time from launch to patent expiry
for new active substances
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Headwinds of changeTrends in biotech financing
Source: DiMasi J.A., Grabowski H.G., Hansen, R.W., 2016. Innovation in the pharmaceutical industry: New estimates of R&D costs. Journal of Health Economics 47, 20‐33.
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Headwinds of changeTrends in biotech financing
Source: DiMasi J.A., Grabowski H.G., Hansen, R.W., 2016. Innovation in the pharmaceutical industry: New estimates of R&D costs. Journal of Health Economics 47, 20‐33.
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Headwinds of changeTrends in biotech financing
Source: DiMasi J.A., Grabowski H.G., Hansen, R.W., 2016. Innovation in the pharmaceutical industry: New estimates of R&D costs. Journal of Health Economics 47, 20‐33.
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A paradigm shiftThe patient at the centre
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A paradigm shiftPatients as partners
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A paradigm shiftFrom clinical trials to the real world
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A paradigm shiftFrom clinical trials to the real world
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What do we need?
Technology tectonics
Quality transparency
Collaboration and continuity
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What do we need?
Technology tectonics
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What do we need?
Quality transparency
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What do we need?
Collaboration and continuity
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What do we need?
Collaboration and continuity
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Thank you for your attention