Clinical Trials

Arana is currently conducting the following clinical trials:

ART621-201:

A randomised, double-blind, placebo-controlled, dose-ranging study to evaluate the safety, efficacy and pharmacokinetics of 3 doses of ART621 following multiple dose administration in subjects with mild to moderate psoriasis

What are clinical trials?

Clinical trials are research studies in which people help medical doctors explore ways to improve treatment of disease. Each study is conducted to internationally recognised scientific and ethical standards and aim to answer specific scientific questions.

Why are there clinical trials?

A clinical trial is one of the final stages of a careful, sequential research process. The research is designed to prove that new medicines and treatments are both safe and effective. Clinical trials are needed to provide safety and effectiveness data to support the Governmental approval of new medicines.

What are the phases of clinical trials?

Clinical testing of a new drug usually progresses in an orderly series of steps, called phases. Each subsequent phase is usually larger and more complex than the preceding phase. This sequential approach is designed to ensure that patient safety is protected. For example lower doses are always tested before higher doses, and small studies are completed before larger studies are commenced. Clinical trials are usually classified into one of three phases:

Phase I trials: these studies are also known as “first in man” studies. They are usually designed to assess the safety and pharmacokinetics of a product and tend to involve small numbers of either volunteers or patients.

Phase II trials: these studies are aimed at helping establish the appropriate dose of a drug and also to evaluate safety and efficacy (how well a drug works) with repeat dosing.

Phase III trials: assuming a product passes Phase II, it progresses into Phase III where the product’s efficacy is compared to the currently accepted standard. At the completion of Phase III a new medicine is submitted to Government Agencies for review and approval (if the data supports this).

Links

Additional information on clinical trials in the Australian context may be found at the following sites. Arana takes no responsibility for information presented on 3rd party sites.

www.medicinesaustralia.com.au/pages/page39.asp
www.nhmrc.gov.au/nics/asp/index.asp
www.tga.gov.au/ct/cthandbook.pdf