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Clinical trials & development of new therapies
Prof Asita de Silva MBBS, DPhil (Oxon), FRCP (Lond)
Clinical Trials UnitFaculty of Medicine
University of Kelaniya
Quality of evidenceI Well-designed randomized controlled trial II-1 Well-designed controlled trials without randomization
II-2 Well-designed cohort/case-control studies from more than one group
II-3 Important results from uncontrolled experiments III Opinions of respected authorities, based on
experience, descriptive studies, or reports of expert committees
Rating evidence: US preventive service task force
US Preventive Service Task Force. Guide to clinical evidence, 2nd edition. Williams & Wilkins, Baltimore, 1996
Development of new therapies: long & unpredictable process
Drug Discovery Pre-Clinical Clinical Trials
FDAReview
Large Scale Manufacturing/ Phase IV
250 Compounds 5 Compounds
Phase I 20-100Volunteers
Phase III 1000-5000Volunteers
IND
Sub
mitt
ed
ND
A S
ubm
itted
10,000Com-
pounds1 FDA
ApprovedDrug
Phase II 100-500
5 years 1.5 years 6 years 2 years 2 years
Volunteers
Cost to develop new biotech product - average US$1-2BClinical trials: approximately 40% of R&D cost
Our collaborators & research
Academic centres of excellence / research institutes• Universities - Oxford, Liverpool, Duke, Duke-NUS • George InstituteResearch-based pharma & biotech companies• Sanofi, Merck, Eli Lilly, Boehringer-Ingelheim, Takeda, AntheraTherapeutic areas• Snakebite, CVD, Diabetes, Stroke, Hypertension, Arthritis,
Dengue, Cancer, Neurology, Ophthalmology & Renal
Future direction & required support
• Improve regulatory environment – by enacting the proposed legislation on clinical research & improve efficiency of regulator
• Comprehensive policy framework to position Sri Lanka as a Centre of Excellence for Global Research & Development to produce innovative therapies and for Pharmaceutical Manufacturing