Lecture 13: Clinical Trials

Question 1

Requirements for starting a clinical trial?

Answer 1

shown proof of concept
written approval from TGA
written approval from HREC

Question 2

Phase I?

Answer 2

identify maximum tolerated dose or limits of device performance
safety, pharmaco…

Question 3

Phase II?

Answer 3

Patients with target disease

Clinical efficacy, optimal dosage and safety

Question 4

Phase III?

Answer 4

Comparative efficacy against other therapies

Question 5

Phase IV?

Answer 5

General usage in large populations, long-term monitoring

Question 6

Regulatory approval for CTN scheme?

Answer 6

by ethics committee, notify TGA only

Question 7

Regulatory approval for CTX scheme?

Answer 7

by TGA, set usage guidelines

Question 8

Ethics committee applications?

Answer 8

Protocol
Investigators Brochure
Indemnity Form (Medicines Australia version)
Proof of Insurance
Patient Information & Consent Forms
Information for HREC package (for CTX applications)
Overseas approvals for Clinical Trials or Registration
Study budget or Clinical Research Agreement
Hospital specific Application Form

Question 9

Ethics committee members? (animal)

Answer 9

• Category A – Veterinarian
• Category B – Scientist
• Category C – Animal Welfare representative
• Category D – Layperson
• Institutional Animal Facility Managers
• University’s Animal Welfare Officer
• An appointed Chairperson

Question 10

Ethics committee members? (HREC)

Answer 10

• Chair - the Pro Vice-Chancellor (Research)
• Laywoman not associated with the institution
• Layman not associated with the institution
• Person/s with knowledge of, and current experience in professional care, counselling or
treatment of people
• Persons (at least two) with current research experience that is relevant to research proposals to be considered by the HREC
• Person who performs a pastoral role in a community
• Lawyer who is not engaged to advise the institution
• Chairperson of each of the Human Ethics Sub-Committees
• A postgraduate student appointed by the Chair on the recommendation of the President of
University of Melbourne Postgraduate Association
• Up to two persons co-opted for particular specified periods
• Deputy Chairperson
• Observers
• Secretary