Clinical trials are the life blood of the pharmaceutical industry, a huge driver of company valuations, and the greatest hope for patients suffering from poorly managed diseases. One major factor that has always hampered clinical trials, for a variety of reasons, is patient recruitment. Many patients are not aware of clinical trials, or their ability to take part in them. Patients generally take the advice of their primary care physicians, many of whom simply do not recommend trials as a treatment option. 

Then comes the coronavirus. How is the COVID-19 global pandemic affecting the ability of clinical trials to run effectively, if at all? To find out, Clinical SCORE surveyed 363 clinical trial sites across a range of settings, provider specialties, and countries.¹ The results show the profound effect of the pandemic on this unique segment of healthcare industry: 

• Trials are struggling for reasons beyond social distancing, as the demand for staff and supplies are diverting resources away from sites attempting to continue trials

• COVID-19 is having a negative effect on trial site staff who, like all healthcare providers, are often on the front lines of this global battle

• Nearly all sites want to keep trials on schedule, a demonstration of their commitment to patients

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. 

A triad of tribulations

As clinical trial sites look for ways to stay the course, three notable challenges are coming to light, namely the effect on clinical trial site staff, the broader effect of missed visits, and the longer-term consequence of protocol deviations.

“It’s hard to balance both patient and staff anxiety.” This succinct statement from one respondent reminds us that clinical trial site staff are people, too. More so, they are the healthcare providers on the front lines of an unprecedented battle. A remarkable seven of 10 sites say that COVID-19 is negatively effecting trial site staff. Managing the COVID-19 fallout on study supplies, and lab samples are noted as the heaviest burdens for research-only sites, where 30% of them reported this as having a substantial impact on site staff’s time. 

Sites also appear to be struggling with the change in clinical trial processes and standard operating procedures. Clinical practices and research-only sites report the greatest difficulty, particularly with the increase in telephone follow-up. Several sites responded saying that the burden of retraining staff when new procedures are created is overwhelming. Sites in Western Europe and Asia-Pacific also note the economic brunt being felt as the coronavirus interferes with trial schedules.

Undoubtedly, trial sponsors share these concerns. As these and potentially other challenges continue and the pandemic wears on, protocol deviations and site closures may be inevitable. Already, over a third of all sites surveyed report protocol deviations. Though a foreboding statistic for study sponsors, it seems this is not due to a lack of effort, as the inability to reach patients, procedure delays, and delays with labs and supplies are cited as main instigators of deviations. About a quarter of all sites believe their trial site has a high likelihood of being closed, though research-only sites are less concerned. Bound to increase with time, these protocol deviations and study suspensions present short- and long-term hurdles.

Hospital sites are hit the hardest

It likely comes as little surprise that academic and non-academic hospitals, along with sites most likely to treat patients with COVID-19, are faring the worst. Academic hospitals and those sites with more than 10 trials were most likely to report that patient visits were suspended. Academic and non-academic hospitals converted significantly fewer trials to virtual visits than any other site type. More than three quarters of academic hospitals are prohibiting on-site monitoring, with larger sites and those in Western Europe reporting the same. Hospitals point to the mandatory focus on patients with COVID-19 and equipment shortages as the biggest effects of the pandemic on the ability to maintain clinical trials. 

Sponsors are a great source of support

Amid these challenges, one thing is clear: study sites want to go on. An outstanding 92% of study sites have attempted to keep trials on schedule. One respondent said, “This is an uncharted territory, but we have to respond appropriately to continue to get meaningful data to advance science.”

Study sites continue to look to sponsors as a source of support. But do sponsors know how to respond? Those sites surveyed noted several ways that sponsors, as well as CROs, could help navigate these uncharted waters:

• Better communication, including guidance, and site staff safety guidelines

• Messages noting what proactive adjustments are being made

• Suggested changes, such as conducting alternate visits and how to better accommodate patients

What the coming weeks look like for healthcare globally, much less clinical study sites, is unclear. The number of surveys completed in the week of March 23 was roughly equal the surveys completed week of March 30. The percentage of active, enrolling sites experiencing substantial delays trended from 54% to 61% over those weeks. 

What will always help is listening to the voices of those in need. If you are a part of a clinical trial study site, speak up. Your suggestions and reports are the beginning of the solution. If you are a study sponsor, be proactive. Check in often, listen, and respond. Clinical trials are designed to discover ways to address unmet needs, but we cannot ignore the needs of those conducting them.

Gary A. Kaplan is Vice President, Analytics; Ross Weaver, PharmD, is President and Blaine Cloud, PhD, is Senior Vice President all with Clinical SCORE, LLC 

References

1. Regions polled include North America, South America, Western Europe, Easter Europe, Asia-Pacific, and Other. Forty-two countries are represented. Trial site locations include academic hospitals, non-academic hospitals, clinical practice, and research-only sites. Specialties included cognitive, oncology, and potential COVID-19 providers.