The world will never be completely the same again after the COVID-19 pandemic. The world of clinical trials won?t be the same either.
Researchers have had to learn a new normal for advancing science in the middle of a pandemic. Social distancing, travel restrictions, economic constraints and the urgent need for vaccines and treatments have forced scientists to adapt their research processes.
It?s tempting to think clinical trials will return to normal after the pandemic. However, it?s probably not that simple. There will be long-term impacts of COVID-19 along with the short-term ones.
Prioritizing COVID Research
The main impact that COVID has had on clinical trials is that COVID research is prioritized. Because of the economic toll of the pandemic, governmental funding bodies are re-directing most of their research money into finding ways to eliminate the coronavirus.
Health Canada explicitly states on their website that it ?will prioritize the review of clinical trial applications designed to investigate the diagnosis, treatment and/or prevention of COVID-19?.?
This means that non-COVID trials may be delayed for the time being. 20% of cancer trials in the U.S. stopped enrolling patients due to COVID and another 60% started enrolling at a lower rate. 86% of cancer trials in Europe are enrolling fewer participants.
Participant safety is obviously a big focus right now in clinical trials. Most trials require some sort of face-to-face contact between participants and clinicians and/or researchers. Often, diagnostic tests or imaging are necessary in the course of the trial. Most non-essential medical visits are being curtailed, slowing down the trial process.
Other COVID-related safety precautions that Health Canada requires include:
- Risk mitigation strategies for trials using immunosuppressive agents
- Involvement of Research Ethics Boards (REBs) to determine whether the study should continue and how best to do it
- Consideration of alternative methods of delivering face-to-face assessments, including phone calls or virtual visits
- Alternative locations to hospitals for imaging studies and laboratory tests
Artificial Intelligence in Clinical Trials
Artificial Intelligence (AI) has impacted almost every area of our lives, and clinical trials are no exception. AI developers have created tools that allow researchers and clinicians to comb through dozens of papers to find the COVID-related information they need.?
Other groups have used algorithms to find drugs that could potentially treat COVID in a matter of days. BioPharma companies that have expertise in creating vaccines or novel drugs are partnering with AI companies to drive drug discovery and clinical trials.
AI had a presence in clinical trials before COVID-19 but the pandemic has accelerated its adoption. The emphasis on speed in controlling the pandemic has caused the scientific community to turn to computing to accelerate the research process. This will drive progress and deepen the link between clinical research and AI.
Virtual Clinical Trials
Most trials still require person-to-person contact, however this does not necessarily have to be the case. Many aspects of a clinical trial can be done remotely through digital means.?
Researchers can send drugs or other necessary materials to participants through mail, they can check in with participants through TeleHealth or phone call, and participants can report symptoms or other pertinent information online. Researchers will have to find solutions to maintain privacy of participant information, but if most people are comfortable banking online, they would probably be comfortable participating in a trial online.
Digital clinical trials could actually improve the effectiveness of trials. Researchers would have access to a more diverse group of participants, especially geographically. Digital trials would also generally be more convenient for participants because they wouldn?t need to travel to take part.?
Virtual trials could also be more efficient because it would reduce any delays associated with arranging face-to-face appointments. However, in order to make virtual trials more efficient, trial logistics would be more important than ever. Delivery of materials would need to be on time and each step in the process would need to be tracked to ensure nothing is being missed.?
This is beyond the expertise of most researchers, but a dedicated clinical trial logistics company, like Bay Area Research Logistics, can offer these services.
More Collaboration and Openness in Research
The COVID-19 pandemic is unique in that it is truly a global problem. Because every country has a stake in eliminating the virus, there has been an amazing level of cooperation between countries and research groups in COVID research.
The National Institutes of Health (NIH) in the U.S. has made it a priority to coordinate between the many groups doing COVID research in order to accelerate the research process. The U.S. and China in particular have increased their collaboration since the onset of COVID-19. The United Kingdom and Italy have also greatly intensified research relationships with other countries.
Researchers have put their egos aside in order to contribute to the collective fight. Usually, scientists are reluctant to share their results before they are officially published because they, understandably, don?t want anyone to steal their research. However, since the pandemic started, scientists are sharing many important results to pre-print websites, such as arXiv, before they?re published.?
Peer-reviewed journals are also publishing articles much faster than they were before the pandemic. One analysis of titles in virology showed that the time between submission and publication had dropped from 117 days before the pandemic to 60 days after. Articles not COVID-19 related also had a significantly longer time to publication than COVID-related articles.
Research Logistics is Vital
One area of research that has changed the most is clinical trial logistics. With the impacts on travel, shipping and supply chain management, logistics is even more complex than it was before the pandemic. This is why it?s crucial to have a logistics expert on your side as you run your clinical trial.
At Bay Area Research Logistics, we help with all aspects of clinical trial logistics, such as planning, packaging, labelling, storage and distribution. Please contact us if you need to navigate this new post-COVID world of clinical trials.