Over the last five years, the landscape of global clinical trial conduct has shifted tremendously. This analysis focuses on the changing dynamics of the top seven countries’ clinical trial distribution over the last five years and looks at the growth of clinical trial conduct in countries with emerging economies, the significance of increased regulations, and the impact the Covid-19 pandemic has had on trial initiations in the top seven countries for clinical research over the last five years. The countries with the highest number of trial initiations in this five-year period worldwide include the US, China, India, Iran, Japan, Germany and the UK.
As highlighted in Figure 1, the US dominated research in 2016, with 23.6% of total trials, almost double the proportion of second-place China’s 12.5% of trials. Japan accounted for 10% of total trials, assuming third position, with 2016 proving to be the country’s best year for clinical research conducted over the last five years. Iran held fourth place with 7.5% of studies, trailed by Germany and India with equal proportions of studies (5.8%), while the UK accounted for 5.7% of studies.
As displayed in Figure 2, China showed a substantial 33% annual increase in research output, accounting for 15.5% of total global research. In 2017, the US demonstrated a comparatively modest 6.7% increase from 2016, holding a similar proportion of trials (23.7%) as in 2016. India also demonstrated a significant research increase, with a 22% increase in trials relative to 2016. On the other hand, Japan demonstrated a decrease in research output, with a 5% decrease in initiated trials with their total share of research falling to 8.9% in 2017. Japan proved to be the only top country demonstrating a decrease in clinical research when shifting from 2016-2017. The remaining top seven countries, including the UK, Germany and Iran, all documented increases in trial initiations in 2017, though these increases were modest compared with China’s.
From 2017 to 2018, China displayed the second greatest percentage increase in newly initiated trials of the last five years, with a 55.5% rise. The surge in research propelled China to assume an equivalent position to the US; although the US only registered a 1.5% increase in research output, both countries accounted for 21.6% of trial initiations. India also had an increase in trial initiations (+23.3%), with the remainder of the top seven, including Iran, Japan, Germany and the UK, all registering decreases. Japan also had the second largest proportional decrease in trial initiations (-11.5%) for a second consecutive year.
2019 serves as a noteworthy year in that it represents the period in which China became the first country to overtake the US in research output. China’s 18.5% growth relative to the US’ 1.0% decrease qualified China as research lead. During this period, India displayed the greatest single-year increase in the last five years, with a 58.2% increase in trial initiations. This increase in trials established India as the third leading research location, with significantly more trials than the fourth-place Iran, which registered a 3.8% increase in trial initiation.
The UK and Germany both registered decreases in trial output of 3.4% and 4.3% respectively. For the third consecutive year, Japan registered the greatest decline in research output, with a -25.7% decrease in trial initiations. This proved to be the greatest decrease observed for the country. Interestingly, in 2018, Japan introduced a Clinical Trial Act to prevent trial misconduct through heightened regulations, so the Act’s enforcement may have resulted in the markedly decreased clinical trial activity.
The Covid-19 pandemic proved to be significantly disruptive to clinical trials, with the US, India, Germany and the UK all experiencing record trial initiation decreases at that point. While China did not have a decrease in trial initiations from 2019 to 2020, the country displayed its smallest rate of growth (11%). In addition, the country’s earlier pandemic timeline relative to other countries in the top seven may have allowed for the introduction of risk-mitigating practices in clinical research, allowing trials to initially resume with fewer comparative disruptions. India presented the largest decrease in trial initiations (-19.9%) one year after experiencing record growth (58.2) in 2019, demonstrating the hugely disruptive effect of the pandemic on the country’s clinical research.
To date, 2021 serves as the first year in which China has experienced a decrease in trial initiations (-10.7%), whereas the US has established its largest increase in the past five years (11.3%), demonstrating successful adaptation to continued research pressures presented by the pandemic. India continues to show a decline in trial initiations for the second year running (-25.6%), similar to Iran, which is also expected to have a record decrease in trial initiations in 2021, with a -32.5% reduction to date. For the fifth consecutive year, Japan continues to show a decrease in trial initiations (-3.2%). Germany also demonstrates a similar trend, with trial initiations decreasing for four consecutive years. Despite this, the decrease in trial initiations from 2020 to 2021 currently stands at 0.1% as the lowest percentage decrease over the last four years. The UK experienced an increase in trial initiations in 2021 (+0.3%), rebounding well from the record fall experienced in 2020 (-14.7%).
The decreased research output during the pandemic years is evident across all the top seven countries, with all countries experiencing a decrease in 2020 or 2021. Interesting is that the US experienced the lowest variability where trial initiations are concerned over the last five years, as well as the greatest increase in clinical research from 2020 to 2021. Countries that demonstrated exponential growth such as China and India, however, are having greater difficulty replicating their record surges in the post-pandemic years.
Japan’s consistently decreasing clinical research over the last five years has seen it drop from third to fifth in terms of trial initiations over the last five years. This trend is strongly correlated with the enforcement of the Clinical Trial Act, which was intended to improve the reliability and safety of studies. With the majority of countries implementing new clinical trial practices following the pandemic, we can expect to see more substantial shifts in the level of research initiated by the top countries in the coming years.