There is no doubt that the COVID-19 pandemic has had a huge impact on clinical trials and the healthcare and research industry as a whole with changes and challenges occurring at an unprecedented rate. It is estimated that there was a -79% difference in the number of participants taking part in global clinical trials from April, 2019 to April, 2020. The ongoing COVID-19 pandemic has re-emphasised the importance of well-designed trials and has highlighted the need for clinical trials to be designed in a coordinated and collaborative manner according to protocol.
Over the last 2 years, clinical trial sites, Principal Investigators (PI) and Sponsors have had to undertake contingency planning to deal with the impact of COVID-19. The planning has focused on the priority of clinical trials (the importance of continuing the clinical trials and the risks that may be associated with it), participation of patients (the ability of participants to participate in the trial while adhering to protocol requirements), and the capacity of the clinical trial (assessment of the available resources needed for continuing the trial, including research staff, clinical support staff, pharmacy support, space and equipment, etc).
Some of the main factors impacted by the COVID-19 pandemic include:
Meetings and Appointments No Longer Held Face-to-Face
The majority of meetings and appointments that usually take place face-to-face were moved online to platforms like Zoom or Google Hangouts, with some even being transformed into webinars. This includes important clinical trial meetings like Investigator protocol seminars and ethics committee reviews.
Although technology has made many aspects of life easier, it doesn’t replace the valuable insight face-to-face communication provides. Participants may not be as upfront with physicians and important things may be missed or skipped over. Ethics committees also believe that an online clinical trial review is not as thorough as an on-site discussion would be.
All clinical trial staff and participants have to be tested for COVID-19 before coming to the clinical trial site. Some tests include a serum antibody test and a chest CT examination which increases the workload during the clinical trial. All staff need to completely rule out the risk of COVID-19 before each clinical trial.
Before each biological sample is sent off to the laboratory, it also needs to be tested to see if COVID-19 is present.
Medication and Supply Shortages
Some clinical trials will face the issue of medication and supply issues (depending on their location and the number of medication or supplies needed). If shortages occur, it’s the Medicine Sponsor’s responsibility to alert the Therapeutic Goods Administration (TGA) and the Trial Sponsors. However, Principal Investigators, pharmacies and Sponsors should develop detailed plans to manage the continuation of clinically essential medication delivery to participants who are in quarantine and participating in the trial virtually.
Deviations from Clinical Trial Protocol
A number of deviations from clinical trial protocol unwittingly occured. This included participants who were infected with COVID-19 and had to quarantine, and the blockage of transportation and deliveries to any residential areas, which resulted in efficacy and safety evaluations being missed.
If deviations occurred, plans have to be made for participants to follow-up at the nearest hospital or participants to take part in the clinical trial from home. The hospitals involved in the clinical trial had to first be approved by the Sponsor. Both the clinical trials completed in the hospital and from home have to have every step and activity recorded in great detail and preserved. This is also required for the medication and supply deliveries.
When the express delivery service was slowed down due to the impact of COVID-19, the deviation from the protocol increased.
Clinical trial participants may have experienced some form of anxiety or stress during the clinical trial. With most of the clinical trials switching to a decentralised/virtual model, some participants may feel depressed and lonely. Investigators end up being not only Investigator and doctor, but also psychologist as they help participants navigate the clinical trial during these challenging times.
The safety and wellbeing of participants is paramount and they should be given the choice whether or not they want to continue to participate in the clinical trial or suspend their participation (if possible). They need to be kept updated of any changes made to the clinical trial processes so they can make informed decisions.
Participants also need to be made aware of what to do if they get COVID-19. They need to inform the research team of their symptoms and diagnosis as soon as possible.
Decentralised Clinical Trial Model
With the advancements in technology, decentralised clinical trial models have slowly been increasing in frequency, however, the COVID-19 pandemic has sped up the process, with most clinical trials having no choice but to adapt to a decentralised clinical trial model.
Although decentralised clinical trials come with their own set of challenges (data security breaches, communication issues, etc), they also reveal an amazing opportunity for medical research in general with participants being able to participate in clinical trials from the comfort of their own home, and provide clinical trial staff with valuable real-time data.
It is predicted that decentralised clinical trials and digital health will still be around long after the COVID-19 pandemic has ended.
Adapting to changes in the medical research and healthcare industries is crucial for the safety and health of all involved, as well as ensuring that quality results are still being produced. The changes made during the COVID-19 pandemic will soon become the new norm as more people see the benefit in decentralised and hybrid clinical trials and digital health. Although the COVID-19 pandemic has been challenging, to say the least, it has opened up the door for change and innovation which can only benefit clinical trials in the long run.
At Novotech, we’re proud to be supporting the latest developments in clinical research, which include technological advancements and the increasing popularity of virtual clinical trials. We have partnered with ObvioHealth, a global virtual research organisation, to provide virtual trial service solutions to hundreds of Phase I to IV clinical trials across a wide range of therapeutic areas.