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Nabil Alhakamy

Australian Experience

الأربعاء - 05 يوليو 2023

Wed - 05 Jul 2023

Dear Reader! I wanted to touch base with you about Australian clinical trials. I recently had a chat with a colleague from an American-Australian company who was impressed by one of my articles on the subject. He shared some interesting insights on why clinical trials in Australia are so beneficial compared to other countries. As someone who's worked in this field for a while now, both in Saudi Arabia and the United States, I'm excited to share some of the most important information on the topic. Let's dive in!

Clinical trials are an essential part of medical research, as they help us understand the safety and effectiveness of new treatments. These experiments are conducted on volunteers and can be used to diagnose or prevent specific diseases. Before clinical trials can begin, preclinical trials are conducted in the lab and on animals to ensure the treatment is safe and effective. Only after these tests are completed and approved by the authorities can clinical trials on humans begin. It's important to note that these trials are conducted with the utmost care and consideration for the well-being of all involved.

Clinical trials are divided into four main stages:

The first clinical phase focuses on studying the safety of the treatment and is often conducted on healthy volunteers and, in some exceptional cases, on some patients, such as cancer patients. The number of volunteers ranges between 10 to 100 and lasts for months.

The second clinical phase focuses on studying the effectiveness of the treatment and the study of side effects and is conducted on volunteer patients, and their number ranges between 100 to 300 and lasts from one to two years.

The third phase focuses on a wider study of the effectiveness of treatment, side effects, and safety on a broader scale where the number of volunteers ranges between 1000 to 3000 and lasts from one to 4 years and may be in a number of hospitals and countries. This phase is considered the last phase before approval of the treatment by the concerned authorities and its availability in the markets.

The fourth phase comes after the approval of the treatment and its availability in the markets and aims to study the effectiveness and safety of the drug in the long run.

Let us return, dear reader, to the advantages of conducting clinical research for biotechnology and pharmaceuticals in Australia. As my American friend mentioned, many benefits are available to small biotechnology startups that come to Australia to conduct trials in the early stages. This is due to the careful and considerate manner in which clinical trials are conducted in Australia, with the well-being of all involved as a top priority. Additionally, Australia has a strong and supportive regulatory environment that encourages innovation and growth in the biotechnology industry.

The most important of these features that distinguish Australia:

1. The speed of obtaining the necessary approvals from the relevant authorities to start clinical trials, as there is no need to get official permission, which saves time and money, as there are ethical review committees that take only five weeks, which is a very big incentive for emerging pharmaceutical companies.

2. Clinical trials in Australia are characterized by quality. All previous tests and data established in different countries, such as the US Food and Drug Administration and the European Medicines Agency, are accepted. There is no need to redo them, which saves money and time as well.

3. Australia is characterized by providing a 43.5% cash discount by the Australian government on all clinical trials, which provides a large amount of capital and reduces financial risks for startups and venture capital companies. It is a major attraction for these companies from outside Australia.

4. There is a big difference in currency exchange rates between most countries and Australia, which makes the total costs lower.

Clinical trials in Australia are within reach of all small startups from various countries of the world.

It seems that Australia could be a more affordable option for conducting clinical trials. However, it's important to prioritize the quality of work and accuracy of data analysis, so it may be worth considering the potential trade-offs before making a final decision.

At the end of this article, dear reader, what about clinical trials in Saudi Arabia, especially in the early stages (Phases 1 and 2)? We can answer this question in an upcoming article...