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