Oncology clinical trial activity in the Asia-Pacific (APAC) region has been robust over the past decade, increasing 138 percent from 2010 to 2020.1 In the past, most studies conducted in APAC countries were later studies, but there has recently been an uptick in the number of phase 1 trials. This bustling activity, in combination with…
The Asia-Pacific (APAC) region now ranks first in the world for total number of active oncology clinical trials, with China alone accounting for more than half of those studies.1 To take advantage of the potential benefits of conducting clinical research in APAC countries, sponsors need to understand the nuances of designing and operationalizing studies in…
In February, the European Medicines Agency (EMA) released the fourth version of its Guidance on the Management of Clinical Trials During the COVID-19 (Coronavirus) Pandemic. As the pandemic continues to impact clinical research worldwide, these updated guidelines reflect the EMA’s evolving stance, clarifying questions raised by previous versions and taking into account the most recent…
In 2019, only 1.2 percent of global clinical studies included India, even though it’s estimated that the country bears 20 percent of the global disease burden.1 One reason for the slow growth of clinical research in India has been the country’s stringent regulatory requirements. The Ministry of Health and Family Welfare, responsible for all health…
The upcoming compliance deadlines for the European Union Medical Device Regulation (EU MDR) have dominated conversations about the increasingly complex regulatory landscape device manufacturers are facing. But it’s important for device manufacturers to remember that regulations are shifting elsewhere in the world as well, including in the Asia-Pacific (APAC) region. In this post, we explore…
Of the 350 million to 400 million people infected with the hepatitis B virus worldwide, one in three lives in China. The country is home to 130 million carriers of the disease and 30 million who are chronically infected.[1][2] Some rural parts of China have an especially high incidence of tuberculosis,[3] and across Asia, prevalence of…
