To better understand the effect of the coronavirus pandemic on clinical trial staff and sites, Clinical SCORE conducted a survey of 363 clinical trial sites across a range of settings and provider specialties spanning 42 countries. Recently published results show the profound effect of the pandemic:
- Treating patients with COVID-19 is steering staff time, supplies, equipment, labs, and vendor servicing away from sites attempting to continue trials
- Site staff, like all healthcare providers, are bearing the brunt, with 7 of 10 sites reporting a negative effect
- Delays and protocol deviations are likely inevitable, with 35% of sites awaiting trial activation reporting that the sponsor postponed starting recruitment and enrollment, 48% of sites actively enrolling and randomizing patients saying they cannot get patients to come in for a visit, and a third of all sites already reporting protocol deviations
Perhaps one of the most noteworthy takeaways of the survey is the dedication site staff have to their trials and patients. A remarkable 92% of study sites have attempted to keep trials on schedule, with just over a third switching all trials to virtual visits. This change, though, demands even more from already weary staff, as new trial processes and standard operating procedures need to be communicated and trained. As one site commented, “Due to the virus, sponsors are amending CRFs and considering protocol amendments. This adds a large burden of retraining for the site staff. This added expectation is difficult to administer.”
Clearly, there is will. What may be lacking is the way, and that is where study sponsors and CROs can step in and step up.
Delays are near pandemic
For nearly two-thirds of clinical trial sites surveyed, COVID-19 and the social distancing enacted to slow the spread of the virus has had a substantial impact on clinical trials. 36% of sites awaiting trial activation report that the sponsor has postponed starting recruitment and enrollment, while 48% of sites actively enrolling and randomizing patients say they cannot get patients to come in for a visit. Perhaps because of this, 34% of enrolling sites have elected to stop seeing patients, or have moved to virtual visits.
As the world reaches to virtual capabilities to bring people together, it is clear that it is not that easy for trial sites. Only 36% of sites have switched all trials to virtual visits, with oncology and potential COVID-19 specialties being the least likely to do so. Research-dedicated sites and those with more than 10 trials appear most receptive to virtual visits, with 53% and 40%, respectively, reporting conversions to remote assessments.
While an average of 45% of sites report visit postponements for enrolling studies, for some, the switch to virtual visits may be a way to stave off the economic fallout. Free-standing sites, whose revenue is dependent upon clinical trials, report site visit postponement for only 24% of trials. Nearly 80% of these facilities report offering flexible trial visits, such as virtual, telephone, and drive-through visits. It is unclear how the shift to virtual visits will change in the coming weeks, if or when the pandemic continues.
Suggestions for support from those on the front lines
Study sites surveyed gave several suggestions for ways CROs and sponsors can help overcome the challenges of conducting clinical trials during this pandemic.
Regardless of site setting, location, number of trials, or provider specialty, respondents noted that CRO-driven adjustments would be most helpful. Helping sites conduct alternative visits, such as virtual, home, or drive-through visits, led the way, with 24% of sites suggesting this support. Sites also noted that adjusting time constraints to better accommodate patients would be helpful.
These suggestions mirror those made to sponsors. The most pressing need is for better communication. Nearly 20% of sites asked that guidance, site staff safety guidelines, and options for data collection be better communicated. An important point to clarify is that “better communication” does not mean “more communication.” In fact, 4% of sites went so far as to specify that they need to not be overwhelmed by check-in calls and emails that don’t bring solutions. “It’s important to realize things are changing every single day. It would be nice if there was some way to streamline the correspondence required by the site to update the CRO/sponsor,” noted on survey respondent.
What sites need is a partner, not a prophet or a parent. Seven percent of responding sites indicated the need for sponsors to adjust study protocols to accommodate for deviations related to COVID-19 and 4% wanted support from sponsors in identifying specific areas where COVID-19 is having an effect. This is clearly born from a commitment to patient safety, as noted by one respondent: “My ultimate goal is subject safety. If veering away from the protocol allows that safety, then I will do it and document it well and for what purpose.”
Sites also asked for table-stake support like providing financial assurance (7%) and better control of study medication and device production and shipment (4%). These are particularly poignant concerns for research facilities (13%) and non-academic hospitals (12%), respectively. As one site honestly shared, “No enrollment will mean no income for our site. This might be a reason for possible closure.”
Lastly, and perhaps most basically, is the need for sponsors to be understanding. Specifically, 11% of survey respondents called out the need for sponsors to face the reality of this pandemic and its effects and to be more patient. For example, “Be patient with data entry. Due to the volume of emails and memos with requests, data entry is delayed. There are only so many hours in a day.” Comments like these show just how deep the burden is felt—and just how much of an opportunity sponsors have to help.
Opening the lines of communication
A good first step in fulfilling those needs may be to continue the conversation started with this survey. Study sites are willing to share their experiences and suggestions with sponsors and CROs that are willing to listen and try. Though the landscape of the coming weeks and months is uncertain, communication and partnership are tried and true ways of managing any crisis.