The global Covid-19 pandemic has impacted clinical research significantly. Focusing primarily on oncology, clinical research disruptions involving experimental cancer therapeutics raise severe challenges, as these trials can be highly time-sensitive and even small administrative delays can prove highly detrimental to patient populations.
As shown in Figure 1, solid tumour studies currently lead as the indication with the highest number of disrupted oncology trials, accounting for over a fifth of disrupted oncology studies (20.7%). Breast cancer trials hold the second largest proportion of disrupted oncology trials (15.1%), followed by non-small cell lung cancer (13.3%), colorectal cancer (11.7%), and head and neck cancer (10.8%).
Currently conducting the highest number of oncology trials coupled with the highest number of Covid-19 cases, it is unsurprising the US has the largest proportion of disrupted oncology trials (41.8%), as displayed in Figure 2. France holds the second-highest proportion of delayed oncology trials (8.0%), with Spain and the UK accounting for an equivalent proportion (7.0%) and with Germany in fifth place (4.1%).
Shifting the focus to those studies that have been resumed following disruption from Covid-19, solid tumour trials also account for the largest proportion of studies (18.8%), and breast cancer and non-small cell lung cancer share an equivalent proportion of resumed trials with 13.7%, while acute myelocytic leukaemia and prostate cancer hold a fourth and fifth place with 9.1% and 7.6% of resumed oncology trials, respectively.
Looking at the country-wise distribution, the US also has the largest proportion of resumed oncology trials (41.6%), followed by the UK (10.7%), France (9.2%), Spain (7.2%), and Japan (4.0%). Japan serves as the only country in the top five for resumed oncology trials to have more resumed trials than disrupted trials. Interestingly, China accounts for less than 1.0% of disrupted trials, but it is second only to the US in terms of oncology clinical trials with a planned, ongoing and suspended status. Nonetheless, as China has been combating the virus for the longest period of time, it is unsurprising that it would have a comparatively lower proportion of disrupted trials, as it is further along the pandemic timeline than other countries, allowing for more time to implement risk mitigating strategies to restart clinical trials. The number of Covid-19 cases reported in China is also far fewer than those in the US.
At present 37.8% of oncology trials that have been disrupted by Covid-19 have resumed; this marks the largest proportion of resumed trials since the disruptions began. The number of disrupted oncology trials has also fallen to its lowest figure in over three months, as seen in Figure 3. This demonstrates that despite a high number of Covid-19 cases worldwide, organisations conducting clinical trials are increasingly becoming able to overcome safety and enrollment challenges by adapting and putting the necessary practices into place to effectively conduct clinical trials.
The pandemic has revealed the advantages in the use of decentralisation and telemedicine to support clinical studies. In a GlobalData poll that was completed between 6 April and 20 April 2020, it was found that 67% of the 853 respondents believed that telemedicine will assume a very important role in the fight against Covid-19, thereby highlighting the increasing level of confidence in such technologies being utilised. A separate poll between 30 April and 18 May 2020, found that the largest proportion of respondents (31% of 468) believed that telemedicine is the most important tool in chronic diseases and least effective in specialist care; this finding is less clear with regards to oncology as cancer can be regarded as a chronic disease that largely requires specialised, tailored care. Furthermore, the use of telemedicine with regards to oncology may be hampered as many experimental oncology medications are granted emergency use authorisation due to a lack of alternatives. These require increased vigilance and monitoring with precautionary measures such as stand-by intensive care unit (ICU) beds.
Observing the ratio of resumed to disrupted trials between different therapy areas, oncology trials hold a greater proportion of trials that resumed (37.8%) when compared with central nervous system trials (30.2%) and cardiovascular trials (26.8%), thus highlighting the urgency for oncology studies to commence. The relatively high resumed rate within the oncology field suggests that trial conductors may be making significant modifications to keep trials open; this may include the reduction of hospital visits where possible, especially when therapies that have immunosuppressive effects are being administered, to minimise risks. In such instances, telemedicine would be vital in ensuring subjects are adequately monitored while also allowing for accurate reporting of adverse events and appropriate support when required. A GlobalData poll that was completed between 18 July and 31 July 2020, also found that the responders thought the main benefit of telemedicine was improved patient access to care (33% of 323 responses); thus in situations where reduced visitation is required, telemedicine could prove to be essential in oncology trials moving forward.
Figure 1: Top Five Oncology Trial Indications Disrupted by Covid-19.
Figure 2: Top Five Oncology Trial Locations Disrupted by Covid-19.
Figure 3: Oncology Trials Disrupted by Covid-19 by Date.