Last month, we discussed how Asian countries have proven to be an exciting and rapidly growing region in which to conduct trials during our webcast, Demystifying Asia: Best Practices for Conducting Multinational Oncology Trials. One of the biggest perceived advantages is the availability of patients. Asia, as a whole, represents 60 percent of the world’s population. In particular, there are groups of patients who are treatment-naive, particularly for the increasing western patterns of diseases and those diseases that are more prevalent in Asia.
One of our esteemed guest presenters, Dr. Louis Chow, an oncologist from Hong Kong and the executive director of the Organization for Oncology and Translational Research, shared his perspective on some diseases that are rapidly growing throughout Asia and becoming high priority, including tuberculosis and seasonal influenza. He also noted that other diseases, such as Hepatitis, breast cancer, small cell lung cancer, and gastric cancer, continue to demand attention.
For those considering registering your product in Asia, we turned to our executive vice president of Asian operations, Chris Wang, to explain the patient enrollment requirements in Asia.
According to Ms. Wang, most Asian countries can assess reduced data for registration purposes, except China. In China, a minimum of 100 patients is required for the active treatment group for chemical products and a minimum of 300 patients is required for the active treatment group for biological products—even if it is part of a multinational trial. If the minimum requirements are not met in the initial study, a second study may be required.
That said, it’s important to keep in mind that longer recruitment periods may occur when patients have access to robust and comprehensive healthcare insurance, such as in Singapore, South Korea and Taiwan, compared to those in countries with limited healthcare experience such as Vietnam. In other words, patients may not need to enroll in a clinical trial if they have very comprehensive health insurance.
In those latter countries, however, trial participation can mean access to that healthcare. And our local experience indicates that some patients are willing to travel a considerable distance to participate in a clinical trial. Late-phase trials, in particular, may benefit from this willingness to participate.
Competition for patients and limited access to treatment-naive patients are issues in countries with smaller populations and excellent research environments, such as Singapore. In contrast, fewer competing trials in countries with less clinical trial experience such as Vietnam increases the availability of potential patients.
Yet Dr. Chow reminds us that, as we look to recruit patients across countries, it is imperative to know and understand the local practice and culture when purposing or approving recruitment plans. It’s also important that the right specialists for the study should be identified and selected.
For more information on patient recruitment and enrollment in Asia, feel free to watch the recorded webcast and be on the lookout for the related eBook and infographic. If you’d like to be alerted when they become available, please leave your contact information in the comments section.
Barb Geiger is the executive vice president, global oncology, at Clinipace Worldwide.