There has been much discussion of the promise of Asia as a setting for clinical research. The access to treatment-naïve patient populations with an increasing burden of diseases such as diabetes, cancer, and heart disease holds great potential for speeding up drug development and reducing its cost.Today, the number of active clinical trials in Asian countries is steadily increasing. Data from clinicaltrials.gov shows that China hosts the highest number of active or recruiting clinical trials, more than well-established clinical research destinations South Korea and Japan.
South Korea has a large pharmaceuticals market combined with a mandatory health insurance system and abundant R&D expertise. In Japan, GCP standards are high and harmonized with international standards, but the country’s stringent approach to regulation often slows down drug development.
China has been referred to as a ‘sleeping giant’, making progress in attracting more clinical trials following a recent overhaul of its drug approval processes and mandatory self-assessment and on-site inspections introduced by the National Medical Products Administration (NMPA). If China can improve its GCP compliance and transparency, it will become even more attractive as a destination for clinical trials.
Challenges and Opportunities for Clinical Trials in Asia
The road to realizing the opportunities within the Asian clinical trial market is not an easy one. Prohibitive regulatory processes have historically blighted China’s efforts to become a global leader in clinical trials, and issues with patient safety, data quality and integrity still remain. After many years of being renowned for the proliferation of cheap generic drugs, India enjoyed a short period as a key destination for clinical trials, before regulatory and infrastructure burdens took their toll.
In addition to regulatory hurdles and issues of quality that have been well documented, the familiar challenges of patient recruitment and engagement require a tailored approach in Asian countries.
One of the first issues is considering how best to recruit Asian patients onto global multi-centre trials. On the one hand, your trial’s marketing strategy may need to take into account the use of search engines other than Google and restrictions on internet access such as the Great Firewall of China.
Another cultural issue related to patient recruitment is the relationship between the doctor and the patient in many Asian countries. Patients in Asia tend to hold their doctor in high esteem. If a doctor recommends a trial, they will likely say yes, but is this truly informed consent? Conversely, if the doctor provides the patient with options or is honest about adverse effects during the informed consent process, this can lessen the authority that Asian patients value so highly.
The issue of trust is well illustrated by the situation in South Korea. Even though there has been rapid development in clinical research, a lack of awareness about trials in the general population has fostered perceptions that hinder patient recruitment. Finding ways to understand patient perceptions and barriers to trials will be essential in these disengaged populations.
Another issue that is common to many Asian countries conducting trials is the lack of data quality that occurs because trials are run by medical staff with little or no trial experience. Therefore, it’s essential to ensure that both patients and site staff have a comprehensive understanding of the study from the consent process and beyond. This requires a focus on training, ongoing visit implementation support, and a focus on ensuring optimal protocol compliance among all stakeholders.
Making the information as easily digestible as possible with translations into the local language is a must. This stretches beyond informed consent to protocols and training materials to ensure GCP compliance. Taking a holistic approach to localization–ensuring that all trial information takes into account local language and culture–is essential.
- New streamlined drug approval processes and overhauled regulations are making Asia a more attractive environment for clinical research
- Conducting trials in Asia will be essential for tapping into the unmet medical needs in these countries as well as harnessing the power of huge populations of treatment naïve patients
- Central to conducting high quality trials in Asia will be ensuring that the tools used to recruit and engage patients, and to train and support site-staff, are fit for purpose, taking into account not just language differences, but cultural aspects too