What are Clinical Trials

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2 What are Clinical Trials Clinical Trials are systematic studies designed to discover and verify the effects and/or adverse reactions of drugs (pharmacodynamics) and the absorption, distribution, metabolism and excretion of drugs (pharmacokenetics) in humans.

3 Why do we do Clinical Trials Laboratory experiments & discoveries Randomised Clinical Trials Safety & efficacy

4 CORU aims To improve the standards of care in NZ by participating in high quality clinical trials and provide innovative treatments To Improve our understanding of the development of cancer and it s clinical behaviour To contribute to advances in treatment

5 Background Drug discovery Synthesis and selection of appropriate formulation Pre clinical tests in the laboratory Clinical development Phase I, II, III Regulatory submission

6 Facts Drug development takes years Cost approx $US 350 million - $US 1.8 billion Only 1 in 10,000 compounds make it to market Only 1 in 3 drugs recapture development costs

7 Types of Clinical Trials Treatment trials observational Interventional Randomised Prevention Trials Screening Trials Diagnostic Trials Quality of Life Trials Correlative Trials Early Access Trials

8 Phases of Clinical Trials Pre Clinical Research & Development involving laboratory and animal studies Determine physical and chemical characteristics Safety and Efficacy

9 Phase I Phases of Clinical Trials Small population Healthy volunteers Short duration days to weeks Assess dosage, formulation & amount Pharmakokinetics & pharmacodynamics

10 Phase II Phases of Clinical Trials Enrol Disease in question Weeks to month IIA dose range IIB response, safety, efficacy Drug Drug relationships, PK & PD

11 Phase III Phases of Clinical Trials Enrol ,000 Confirm efficacy, complete safety, assess risks & benefits 2 pivotal trials plus special trials Drug interaction studies Effects on performance status Usually randomised and maty be placebo controlled

12 Phase IV Phases of Clinical Trials Post Marketing Surveillance Regulatory commitments Monitor efficacy in large population Identify problems including late & rare side effects Compare drugs with those of competitors Change formulations and dosages

13 Eligibility Clinical trial is open to all who meet the inclusion/exclusion criteria. Willing to consent South Island wide regardless of geographical location

14 Benefits of trial participation Access to new interventions Intervention being studied maybe more effective Regular & careful medical attention Results may help others Increased scientific knowledge

15 Changes over the years 1950 s Link between smoking & lung cancer Hormone s & cancer 5FU discovered 1960 s Prevention Scientists discover process of angiogenesis Hereditary link 1970 s First Oncogene discovered Simple mastectomy replaces radical mastectomy Tamoxifen as breast cancer prevention

16 Changes over the years Development of monoclonal antibodies 1980 s PSA screening Role of Dentritic cells for vaccines Taxol developed HER 2 overexpression in 15%-30% BC 1990 s VEGF discovered BRACA1 gene discovered Exercise found to reduce risk of cancer in post menopausal women

17 Changes over the years Irinotecan approved Testing os avastin begins Herceptin approved for use 2000 s Cox 2 inhibitors approved Monoclonal antibody Cetuximab slows cancer growth Vaccine developed to prevent cervical ca CEA test developed

18 Changing face of clinical trials Then. Treatment decisions based on tumour type Healthy cell damage & unwanted side effects Comparison of 1 cytotoxic or combination with another Few hormone only or chemo/rad trials Clinical trials less complicated Larger numbers recruited

19 Changing face of clinical trials Now.. New approaches with less side effects Immunotherapy Hormone therapy Targeted therapies Monoclonal Antibodies Kinase inhibitors Mutations and genetic marker Individual tumour testing

20 Changing face of clinical trials Case report forms electronic Data collection larger and more complex Investigations more complex Tumour evaluations more frequent Numbers involved in trials greater

21 Conclusion Science and technology are advancing at a rapid rate The direction of cancer research is changing Move from disease specific to individualised therapy Trials are becoming more complex and costly

22 Progress against cancer requires participation in clinical trials to carefully test the efficacy & safety of new treatments and to identify new avenues to prevent cancer, detect it early and increase survival and cure rates We depend on the willingness of our patients to take part in Clinical Trials