In a recent follow-up blog post to our webcast, “Demystifying Asia: Best Practices for Conducting Multinational Oncology Trials,” we shared one of the main advantages of taking clinical trials to Asia:Patient availability. However, we wanted to address a potential concern we heard from our webinar attendees—data quality. One question in particular that was raised in regards to quality: Can we be guaranteed comparable training and GCP compliance from Asian sites?
In our experience, quality of data in many Asian countries, particularly those with previous clinical trial experience, is comparable to that obtained in the US/EU. Well-trained investigators in these countries help ensure that international standards are followed.
One of our esteemed guests, Dr. Louis Chow, an oncologist from Hong Kong and the executive director of the Organization for Oncology and Translational Research, shared that sites in Asia must get prior approved by their respective country’s health authority (comparable to our FDA) before being allowed to conduct a study. So, for our western sponsors, this is something different because, in the U.S., sites don’t have to be approved by the FDA.
Dr. Chow went on to explain that in China, specifically—a key emerging market with one of the largest increases in the number of registered multinational clinical trials—only designated sites can perform clinical trials, and that training is mandatory for its investigators. There are approximately 200 to 300 sites certified by the China FDA, and all of those sites have investigators that have been trained to perform clinical trials. In fact, most investigators have participated in many training courses provided by different agencies and institutes over the years.
My colleague and executive vice president of Asian operations, Chris Wang, also explained most of our staff has experience working for international pharmaceutical companies, making it much easier to enforce adequate data quality and consistency. In addition, training is routinely provided to the sites, and whenever a new site staff member joins, training is arranged immediately. Beyond that, if monitors identify an issue at a site, additional briefings and trainings are scheduled for the staff, as necessary. US FDA also conducts inspections in Asia and many of our sites have been inspected with no findings. South Koreans sites have been exceptional in their data quality.
Another concern we addressed during the webinar was related to localization. Considering most electronic data systems are in English, the question was whether Asian sites are able to enter their data in English, or would the system need to be in the local language.
According to Dr. Chow, this is not a problem because most of the study sites in Asia, including China, are able to enter the data in English due to British and US influence. However, one document that must be translated is the informed consent because explaining trial nuances in the native tongue of the patients ensures they fully understand the nature of the trial. Other submission documents may also need to be translated – the requirements vary by country.
However, if quality and consistency of data remains a concern, it may be beneficial to look into the use of a cloud-based software system, such as Clinipace’s TEMPO™ eClinical platform, which has the ability to store protocols, newsletters, training documents and FAQs that are study-wide or specific to a country, provides real-time visibility to operational progress, and allows access to start-up data. Transparent access to data, regardless of where it’s collected, enables decision-making relating to that data on a real-time basis, thereby saving time and preventing delays. Centralized, transparent, and real-time data access enables monitoring and ensures data quality across all facets of the clinical trial.
For more information on therapeutic areas in Asia and the benefits of clinical trials in the region, feel free towatch the recorded webcast, and be on the lookout for a 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 an executive vice president, global oncology, at Clinipace Worldwide.