China’s low proportion of disrupted clinical trials sets example for sponsors

GlobalData Healthcare 10th September 2020 (Last Updated September 10th, 2020 15:48)

Over the last three months, the number of clinical trials being disrupted due to COVID-19 has been decreasing, despite a rise in the number of COVID-19 cases.

China’s low proportion of disrupted clinical trials sets example for sponsors

Over the last three months, the number of clinical trials being disrupted due to COVID-19 has been decreasing, despite a rise in the number of COVID-19 cases. This suggests that organizations conducting clinical trials are adapting better to the challenges presented by COVID-19 than they were previously. The rate at which studies are resuming is significantly lower than the initial rate of increase in disrupted trials, which suggests that clinical trial disruptions will persist for the foreseeable future. It is therefore paramount for sponsors to identify and implement risk-mitigating practices, including decreased visits to trial sites, enhanced safety measures, increased use of telemedicine, and effective site selection by focusing on locations where clinical trials are least likely to be disrupted. The US currently has the highest number of disrupted trials, followed by the UK, Germany, Spain, and France.

To provide a more accurate breakdown of the clinical trial disruption caused by COVID-19 by country, GlobalData has analyzed disrupted trials from countries with over 500 ongoing and planned trials. As shown in Figure 1, the UK has the highest proportion of disrupted studies at 8.1%, more than any other country with over 500 ongoing and planned trials. This suggests that the UK’s mitigation and adaptation processes may need further assessment regarding their effectiveness. One of the factors accounting for this level of disruption may be difficulties in patient recruitment, as there have been widespread reports that a majority of UK residents are more hesitant to return to their pre-pandemic practices compared with their European counterparts. As such, study participants may be less likely to participate in trials. Furthermore, the Medicines and Healthcare products Regulatory Agency (MHRA) has provided extensive guidance on managing clinical trials during the COVID-19 pandemic, in which it outlines patient safety as a principal concern. These stringent requirements to restarting disrupted trials may increase the length of trial suspension in order to ensure that sponsors have all required practices in place to safeguard trial subjects.

As shown in Figure 2, China has the smallest portion of disrupted clinical trials due to COVID-19, at 0.3%, followed by India, Japan, Thailand, and South Korea. China’s current low proportion of disrupted trials may be attributed to two factors. The first factor is China’s widespread integration of telemedicine and use of COVID-19-mitigating strategies in trials. However, the use of decentralized trials may have been accelerated beyond China’s pre-COVID-19 infrastructure, leading to difficulties in accurately gathering and reporting data. The second factor is that China is further along in its pandemic timeline and thus has had more time to resume clinical trials and identify the best strategies to adapt to the challenges presented by the pandemic.

Both the top five countries by number of disrupted trials and by proportion of trials disrupted only contain European, North American, and South American countries. The Asia-Pacific region is underrepresented in these lists, as the lowest

proportions of disrupted to ongoing and planned trials are found in this region. Figure 3 shows that Asia-Pacific countries with the highest number of ongoing and planned trials have a much lower proportion of disrupted trials than the US and France, highlighting that lessons can be learned from the adaptation and mitigation strategies being utilized in this region.

The US, India, and Brazil have the highest number of COVID-19 cases, but all have a relatively low proportion of disrupted trials, at 3.8%, 0.5%, and 3.2%, respectively. This suggests that a high number of cases does not serve as the main cause of trial disruption and that key factors for disruption involve hesitation in patient enrolment, logistical issues, and a reduced usage of decentralized trials. This is especially evident with New Zealand, where there are a low number of cases alongside a higher rate of proportional trial disruption, at 4.6%.

Currently, the clinical trials landscape is highly dynamic. Organizations that can conduct decentralized clinical trials on a wide scale while overcoming logistical challenges will fare well during the remainder of the pandemic. Consequently, China’s current successes with keeping trials running, a relatively low number of COVID-19 cases, and a large population size have made it a very attractive place for sponsors to run clinical trials. As such, it would not be surprising if there is a surge in the number of clinical trials being conducted China in the short-term future.