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International Clinical Trials

The Pacific Rim

In the US and EU, approximately 35% of trial delays occur as a result of patient recruitment, and one-fifth of the trials in these countries do not enrol a sufficient number of subjects. Shown in Figure 1, to expedite the recruitment process and avoid drug approval delays, both the US and EU have increased their number of registered clinical trials in developed Asian countries such as Japan, South Korea, China, India, and Malaysia (1).

It is well known that the primary barriers to conducting clinical trials in the US and Western Europe involve challenges in participant recruitment and retention, resulting in longer lead times and high costs (2). Furthermore, contracting qualified and experienced investigators and key opinion leaders add to the already lengthy trial times (3).

A 2013 analysis found that almost 57% of trials fail due to low patient accrual rates, which could translate into huge financial losses (4). Adding to this recruitment problem, racial and ethnic minorities, women, and the elderly are often under-represented in enrolments. For example, a study found that only 25% of elderly cancer patients enrol in trials, although they account for 63% of new cancer cases (5).

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About the author

As Chief Medical Officer of Linical Accelovance Group, Dr Tracy Goeken is responsible for providing strategic and operational leadership regarding the company’s global medical and scientific operations. Dr Goeken oversees clinical development functions and activities within the company, including medical, regulatory, medical writing, and pre- and post-market pharmacovigilance departments ensuring global alignment and operational excellence. Tracy received his MD from St. Christopher’s College of Medicine, UK, having completed his clinical training at LSU Health Sciences Center in Louisiana.
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