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叶勤--推动精准医药开发——医疗大数据和通用数据模型应用案例.pdf
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2021-03-30
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Unlock the potential of precision medicine
Role of real world data and common data model
推动精准医疗开发 - 医疗大数据和通用数据模型应用案例
Dr. Qin Ye, Global RWE Lead
June 30, 2018, Guangdong China
2
The continuous increase of costs with declining productivity means
an overhaul of the R&D model more important than ever
$2.6 Billion
Average' R&D'cost' per'
approved 'NME 'v ersus'
just'$1B'ten'years'ag o
~5.5%
ROI'of'R&D's pen d'in '
2014,'declini ng'from'
10%'in'2010
â 30%
Decline'in 'th e'to tal'lifetime'
rev enues'of'pharma'assets
(2#of#10#drug#revenues#>#R&D#cost)
Patient enrollment is a leading cause
of delays
37% sites under-enroll patients
11% sites fail to enroll a single patient
Challenging
Patient
Enrollment
Protocols today have twice as many
end points, eligibility criteria, and
investigative sites as used in the past
Increased
Complexity
80% of clinical trials fail to meet
milestones due to operational delays
while conducting the trial
Increased
Cycle Times
High
Opportunity
Costs
Half the total cost of bringing a drug
to market is attributable to opportunity
costs associated with a lengthy drug
development period ($403 million)
of 12
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