How Do Clinical Trials Differ from Country to Country?
Australia is considered one of the best places to carry out clinical research and trials due to its world-class infrastructure and high-quality clinical facilities. Australia’s Good Clinical Practice (GCP) reputation means its clinical data is accepted by international agencies, including the US Food and Drug Administration and the European Medicines Agency.
According to a 2005 study carried out by The Economist (Benchmarking Study of the Australian and International Pharmaceuticals Industries), Australia was the number one country to carry out pharmaceutical clinical trials. This is largely thanks to several top-tier CRO companies like Novotech CRO that offer a highly reliable and cost-efficient clinical trial solution in several Asia-pacific regions.
Contents
Guidelines & Regulations
Naturally, clinical trials follow strict international and national guidelines, which must be met at all times. At the forefront is the International Conference on Harmonisation, which sets the standards of conduct for clinical trials worldwide and provides a framework for national regulatory bodies. Good Clinical Practice (GCP) is also a crucial guideline to follow for international CRO companies.
As a Commonwealth country, Australia’s guidelines are also principally based on the European Union with the Therapeutic Goods Administration (TGA) regularly reviewing and modifying the European Community (EC) guidelines to fit Australian laws. However, the methods for implementing these international regulations differ from agency to agency and depending on the differences in the standard of care and each country’s cultural practices.
Cost
According to a 2016 study conducted by Frost & Sullivan, it can be up to 60% cheaper to conduct a clinical trial in Australia than in other countries, particularly compared to the US. The main reason for this is because of the Australian government’s tax incentives (cash rebates) in which money is refunded within a specified time.
Application Requirements
The main difference between the application requirements of Australia, the US, and the EU include:
- Australia: Clinical Trial Notification (CTN) or Clinical Trial Exemption Scheme (CTX) applications.
- EU: Submit a Clinical Trial Application (CTA) to the relevant national authority in Concerned Member State.
- US: The investigator completes an Investigational New Drug (IND) form.
Key Documentation
- Australia: Investigator’s Brochure (IB), Informed Consent Form, Protocol form, and Patient Information.
- EU: Investigator’s Brochure (IB), Informed Consent Form, Investigational Medicinal Product Dossier (IMPD), Protocol Form, and Patient Information.
- US: Investigator’s Brochure (IB), Investigational New Drug form (IND), Informed Consent Form, Protocol Form, and Patient Information.
Australia has a reputation of being an ideal place to conduct clinical trials due to its well-equipped facilities and having some of the best researchers in the Asia-Pacific region, not to mention it is lower in costs than other countries.
