Understanding the benefits of the Analytical Target Profile (ATP)
The 2022 revised version of ICH Q14 describes the ATP as a prospective summary of the performance characteristics describing the intended purpose and the anticipated performance criteria of an analytical measurement.
Immuno-oncology – Asia pacific – clinical Trial landscape
Asia Pacific has shown significant increase in Immuno-oncology trials between 2017 and 2021 and contributes to more than a third of the global clinical development of Immune-oncology drugs.
Modern Technologies Transforming Clinical Development in the APAC Region
Traditional clinical trial models are outdated and causes multiple issues for patients, trial sites, and sponsors. These issues are predominantly related to low patient recruitment and retention rates, leading to trial delays and high costs.
The role of real world evidence to support US FDA and TGA registrations
Real world evidence (RWE) can contribute valuable information to new medicine registrations, in particular for diseases that are difficult to assess in randomized clinical trials (RCTs) and for emerging technologies such as gene and cell therapies to help enhance our understanding of such products.
Evolution of Clinical Trials in the Asia Pacific Region Compared to the US and the EU5
Over the last five years, the global clinical trial landscape has changed significantly. During the analysis period between 2017-2021
Our Latest Reports
Non-alcoholic steatohepatitis (NASH) Asia Pacific – Clinical trial landscape
The global burden of NASH is expected to rise due to Asia Pacific's larger proportion of the world's aging population and a relatively higher prevalence of NASH (~60%) particularly in South Asian countries than in the West.
Parkinson’s disease - Asia pacific – clinical Trial landscape
Due to the presence of half of the world’s aging population and a high population growth rate in APAC, the global burden of Parkinson's Disease is expected to rise, with China, Japan, and India collectively contributing to over a quarter of the cases.
Clinical trial landscape of Liver cancer in asia pacific
According to the Globocan 2020 report, liver cancer is the fourth most frequent cancer in Asia, with the region accounting for over 70% of all new liver cancer cases worldwide. Hepatocellular carcinoma (HCC) and bile duct malignancies are highly prevalent in Asia, especially in China and South Korea where the prevalence rate is about five times higher than in Western countries.
Clinical trial landscape of diabetes (type 2) in asia-pacific
Diabetes, which is endemic in most Western countries, is now seeing a surge in developing nations across Asia due to aging, urbanization, and changing dietary habits. It is estimated that about 80% of the people with diabetes now reside in developing countries, and mortality rates due to diabetes are higher in the Asia-Pacific compared to the rest of the world.
Clinical trial landscape of endometrial cancer in asia-pacific
In 2020, Globocan reported over 400,000 new corpus uteri cases, with Asia accounting for about 40% of these new cases. China, where EC is the third most common female malignancy, accounted for nearly half of the new cases in Asia.
Regulatory requirements for clinical trials in Australia
With a streamlined regulatory environment, including no requirement for an IND, and the supportive R&D Government refund of up to 43.5% on clinical research spend, Australia has become a preferred destination for early phase clinical trials.
Accelerating Genetic Therapy Clinical Trials in Asia-Pacific
A growing number of biotechnology companies, both in the West and in Asia, are specializing in gene therapies and other regenerative treatments boosted by the approval of the first genetic therapy agent (tisagenlecleusel) by the FDA in 2017.
Accelerating Immunotherapy Clinical Trials in Asia-Pacific
Over 600 sites across Asia-Pacific have been involved in the clinical development of now approved IO drugs, and hundreds more are experienced in managing clinical trials with immunotherapies for both monotherapy and combination therapies.
Orphan drug trials accelerating in Asia Pacific
We have observed an unprecedented effort in the clinical development of Orphan drugs in the recent years. In fact, in 2018, the majority of new drugs approved by the FDA and EMA were Orphan medicines.
The objective of this report is to describe the Orphan drug development landscape and explain how the positioning of the Asia region has been evolving in the global picture.