The emergence of the novel Coronavirus/COVID-19 has been a true test of the Society for Clinical Research Sites’ (SCRS’) mission: to unify the voice of the global clinical research site community for greater site sustainability. On March 12th, SCRS released a survey to better understand the challenges sites are facing, their level of preparation to navigate the current global reality and site needs related to the COVID-19 pandemic. It is important that SCRS continue to be the leader in advocating for site needs and educating the clinical research industry regarding how to navigate and address the challenges our industry is facing.
Of those who participated in the survey 84% are from site organizations, 8% are from sponsor or CRO organizations and 8% are from professional solution providers. Of the site respondents, 39% are part of a site network.
Patient and Site Impact:
One of the major concerns that unprecedented events such as the COVID-19 pandemic raises is the impact on clinical trial enrollment and retention, as well as the safety and well-being of currently enrolled patients. A vast majority of sites – 58% – anticipate that COVID-19 will negatively affect their enrollment. This is supported by respondents’ view of patient retention and the challenges government restrictions place on keeping patients enrolled in studies. Nearly half of respondents (47%) feel COVID-19 will have a negative effect on retention, and 37% of respondents were still unsure of the impact on retention. This indicates a strong need for providing support to sites that will enable and enhance patient retention as well as help them identify innovative solutions that extend beyond current trial models.
At the time of the survey, most sites were confident that this issue would not adversely affect the safety of their patients as it relates to the trial. With 36% reporting it might or might not impact patient safety and 36% reporting it probably or definitely will not, sites are confident that they will be able to monitor and maintain the safe and ethical treatment of their patients to the best of their ability
Changes in Trial Conduct:
Most sites are beginning to see changes to trial conduct, particularly regarding the incorporation of decentralized/remote/virtual measures or activities. 49% of respondents reported an increase in the incorporation of plans to integrate remote elements into trials to ensure the trial continues with minimal impact. With recent guidance from the Federal Drug Administration (FDA) to go virtual in response to the COVID-19 pandemic, the emphasis on being prepared to conduct study visits and activities virtually has increased and it is important that sites begin preparing for this immediately. SCRS is happy to report that 42% of sites indicated they are prepared to implement virtual elements into their trials. An equal number, however are still discussing this possibility and navigating the incorporation of virtual elements like remote study visits.
SCRS has created a pathway for sites to prepare to incorporate virtual elements into their trials by providing access to a Virtual Trial Capable Training program at no cost, in partnership with Global Impact Partner (GIP) VirTrial. The series of modules take less than 20 minutes to complete and lay the foundation for sites to participate in decentralized clinical trials (DCTs). With a majority of survey respondents indicating they have not taken this training, SCRS is calling for sites to immediately prioritize taking the Virtual Trial Capable Training. Doing so will increase the global site community’s preparation for the eventuality of virtual elements being incorporated into clinical trials.
58% of sites expect a negative impact on enrollment
47% of sites believe COVID-19 will negatively impact study retention
49% of sites reported an increase in the incorporation of virtual trial elements