The COVID-19 pandemic has drastically derailed onsite clinical trials worldwide, leaving lasting impacts on the life science sector. Clinical trials often deal with vulnerable groups of people who are at the highest risk if exposed to COVID-19, so a large percentage of trials have been paused or stopped altogether. Social distancing regulations have forced clinical trials to change the way they are conducted, and it looks like these adaptations are here to stay.
The pandemic’s impact on clinical trials
Globally, clinical trials that are not researching COVID-19 have been put on the backburner. This has resulted in severe delays in timelines and in some cases a complete halt of operations. The delay in timelines has led to setbacks in the development of other life-saving drugs. At the start of the pandemic, more than 1,500 clinical trials researching treatments for cancer, heart disease, and other serious illnesses were permanently closed down due to the virus.
Elective surgeries and other hospital services that were not COVID-19-orientated have also been delayed. This has seen a lasting impact on tumour banks that store cancer samples. Medical students will have less hands-on practical knowledge leading to potentially lesser qualified medical professionals. Alongside this, cancer researchers have less to analyse leading to further delays in cancer treatments. Despite elective biopsies restarting recently, cancer researchers have complained that the depleted number of samples has led and will continue to lead to reduced basic research.
New methods of conducting clinical trials
The number of enrolments in onsite clinical trials has plummeted as participants stay away from hospitals in an attempt to avoid the virus. A recent survey found that 35% of respondents feel worried about going to a hospital or clinic during the COVID-19 pandemic. To overcome this, life science professionals have had to be innovative and change their approach to clinical trials
Informa Pharma and Oracle recently surveyed 251 life science professionals from biopharmaceutical and medical device companies. They found that due to the pandemic, 84% of the respondents adopted alternative trial methods so that they could continue their existing clinical trials or start new ones. These new methods have worked well, with 97% of the life science professionals stating that they will continue using at least one of the newly adopted approaches.
New approaches saw virtual clinical trials become increasingly popular. Among the newly adopted virtual methods that companies plan to continue to use post-pandemic, remote monitoring (32%), video visits (28%), electronic health records (24%), and phone visits (24%) were top of the pack.
The benefits of virtual trials
Virtual trials offer the opportunity for large population samples. For example, lower-income or underrepresented participants who were previously unable to engage in clinical trials due to work schedules or transportation access, may now find it easier to participate virtually. This method has also broadened the potential for studies to have wider geographic coverage, and even contribute towards greener, more sustainable clinical trials.
A recent survey found that 44% of organisations will continue to use decentralised trials alongside in-person traditional clinical trials. Many respondents (61%) believe allowing patients’ choice of the trial method will have a positive impact on clinical research and well over half (58%) said that their organizations plan to give patients the option to choose how they participate in clinical trials moving forward.
Previously, clinical trials could typically take 6-12 months for the implementation and the recruitment of the participants. However, due to the speed of the virus virtual clinical trials were forced to be up and running in a matter of days. Such trials have brought benefits such as timely data access and improved flexibility for patients, and with all the benefits that they offer, it’s likely that more organisations will look to conduct decentralised, or partially decentralised, clinical trials in future.