Social distancing. Country-wide lockdowns. Mask mandates. In the last year, people around the world have been forced to adapt their everyday lives to mitigate the spread of COVID-19 – and the clinical trial community is no exception. The COVID-19 pandemic has presented a variety of challenges and limitations for trial managers. Many contract research organizations temporarily paused and/or adapted the processes of ongoing clinical trials to ensure patient safety and comply with governmental regulations. In some cases, those adapted processes have accelerated operations to allow for the rapid implementation of COVID-19 clinical trials. In many cases, the new processes include testing study subjects for COVID-19 before enrollment. What are some of the other ways that clinical trial teams have modified clinical trial management since the advent of the pandemic? Will these alterations influence the future of clinical research?
Changes to Clinical Trial Management During the COVID-19 Pandemic
COVID-19 has raised many questions and presented many challenges for those in the clinical research field. Numerous aspects of the industry have been impacted, including patient safety, participant recruitment, data collection and management, and treatment delivery. Clinical trial teams have worked together to respond to these challenges through a variety of methods, including temporarily or permanently pausing procedures, adapting administration strategies, and using technology to find innovative solutions. Researchers around the world have acted quickly to design and conduct new clinical trials to investigate treatments and vaccines for COVID-19, as well as to adapt existing clinical trials to ensure the safety of patients and staff members.
It’s clear that clinical trial teams must continue carefully collaborating with sponsors in order to deliver high-quality clinical trials that prioritize participant safety. In addition, looking beyond the pandemic, by using the knowledge gained and the innovative solutions developed during this stressful time, clinical trial teams can continue to improve the design and conduct of research going forward.
Confronting Obstacles with Caution and Creativity
Participant Recruitment
One critical impact of the pandemic has been a decline in the availability of people willing and able to participate in a clinical trial. New models of patient recruitment and enrollment are being considered and innovative solutions are being tested all the time. These new models strive to ensure that clinical trials can proceed, ensuring adequate numbers of participants and safeguarding both staff and study subjects.
Furthermore, many teams have found success using different forms of communication with potential participants, such as video conferencing. Remote communication is often a successful alternative to face-to-face contact, even when obtaining informed consent for participation. More and more clinical trial teams are exploring electronic informed consent; however, electronic informed consent is still relatively uncommon in the industry as a whole and this is typically still implemented in face-to-face settings. In the future, many electronic consent systems will likely be adapted for remote online use, though researchers will need to carefully consider potential limitations and challenges of electronic informed consent forms, including accounting for the demographic of the study population, ensuring signature validity, gaining participant trust, and adhering with federal guidance.
Communication with Team Members and Sponsors
Although clear and regular communication with staff members and sponsors is always important, it has been especially important during the pandemic due to the possibility of rapid changes in trial procedures. To make sound decisions regarding these changes, trial managers must seek out input from site staff who can tell them what is happening “on the ground” and help them avoid missteps. This prevents them from focusing too much on one element of the trial, such as recruitment or retention, and ensures they focus on the success of the trial as a whole. In addition, trial managers must explore different communication styles to ensure they use the best method for each situation.
Treatment Delivery
Clinical trial managers have had to assess whether the clinical trial treatment can be delivered to participants without sacrificing safety. It’s often necessary to explore all of the options for delivery to determine which is the safest. For example, some trial managers have found it possible to deliver the treatment directly to participants, without requiring face-to-face visits, and some have used remote follow-up appointments.
Data Collection
Some trial managers have shifted data collection processes during the pandemic, following thorough risk assessments. Although data collection has proceeded relatively normally, sometimes there have been delays in timelines. In some cases, trial managers began handling data entry, though this has sometimes caused logistical problems due to them working from home. Some trials that used participant-reported data collection have shifted to online or telephone data collection. Although this has improved safety, it has raised other concerns, such as potential issues in collecting sensitive information over the telephone and converting to online data collection. The process has been easier for sites where online data collection has been used or explored in the past.
Clinical Trial Staff Training
Previously most trial-specific training was provided face-to-face, but due to travel restrictions and safety guidelines, many trial managers have devised alternative methods of training. Although virtual training technology existed prior to the pandemic, many research teams had continued to use the traditional training approaches they were familiar with, including face-to-face training sessions (which can be expensive and time-intensive) and teleconferencing (which lacks the human interaction of face-to-face communication). Due to COVID-19, many teams have been forced to consider and quickly implement new approaches, such as video conferencing, webinars, and short training videos. Video conferencing, in particular, has been shown to be a worthy alternative, as it’s efficient, inexpensive, and enables human interaction.
COVID-19 Research
As some clinical trial teams delayed or altered upcoming research due to the pandemic, other clinical trial teams pivoted to assist global efforts to combat the pandemic by conducting clinical research related to COVID-19. For example, the United Kingdom’s National Health Service (NHS) quickly revamped procedures and made use of technology in order to run the biggest randomized COVID-19 clinical trial in the world. These accelerated efforts have taught the clinical trial community many lessons, including the importance of streamlining bureaucracy.
Additionally, COVID-19 clinical trials have raised the profile of clinical trials among the general public, demonstrating how important they are to the development of urgent, safe, and effective therapies and vaccines.
Looking Forward
Although the coronavirus has presented many challenges and setbacks, it’s important to recognize that it has also pushed clinical research teams to implement new procedures and technologies at an unprecedented speed. Clinical trials have a history of being complex, expensive, and time-intensive, so it would be beneficial if the lessons learned during this difficult time could be applied to clinical trials in the future. To ensure this happens, it is important for clinical research teams to share best practices and innovative new approaches with other teams so that they can learn from one another.
It’s impossible to predict how the COVID-19 pandemic will impact the design and management of clinical trials in the months and years to come. By working together and harnessing lessons learned during the pandemic, such as the importance of transitioning to digital technologies, clinical trial teams can continue producing high-quality, efficient, and effective clinical research.
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