Gary A. Kaplan

In March, Clinical SCORE began a series of surveys with clinical trial site staff to better understand the challenges they were facing during the COVID-19 global pandemic, and how sponsors and clinical research organizations (CROs) could help. Results from the first survey, 

painted a bleak picture. Subsequent surveys showed 

for sponsors and CROs. After another three months, we reached out again to see how those challenges were evolving and if those needs were being met.

In total, 202 Principal Investigators (PIs) and Study Coordinators (SCs) responded. As in previous studies, about half of respondents were from sites in North America (55%), with site staff in Eastern Europe being the next biggest contributor (17.8%).

31% of respondents were from clinical practices and academic hospitals each, with the latter showing a response rate now similar to that seen in the first survey after significant declines in the second and third surveys. PI respondents, again, represented a variety of specialties, with cardiology having the largest influence (31%). What they had to say was both promising and consistent.

In looking at the responses from the first survey when the pandemic began through to this current survey, it appears that trial activity has increased. In the first three waves of the survey, only about 25% of sites had 10 or more active trials. In this current survey, nearly 60% of respondents reported having 10 or more active trials. Yet the overall mean number of trials per site remains lower than in April.

The focus of active trials has also changed. COVID-19 vaccines and treatments now make up 25% of the reported active trials, with the majority being conducted at academic hospitals. Interestingly, the specialties of the PIs at sites conducting COVID-19 studies extends well beyond the pulmonologists and allergists one may expect.

*Percent of all sites conducting COVID-19 studies.

These data from the fourth survey show a far lower percentage of respondents reporting that COVID-19 has had a substantial effect on the ability to conduct trials (33%) compared with the first and second surveys (56% and 52%, respectively). The burden of managing study supplies has also decreased, from 23% and 31% in wave one and two, respectively, to 16%. This overall trend in the easing of pandemic’s negative effect on staff is capped by the difference in the percent of PIs and SCs reporting that COVID-19 has had a substantial effect on site staff, which was as high as 73% of respondents in waves one and two, respectively, now down to 36%.

Sponsors responded but sites need financial support

Study site staff were vocal about their needs during the early months of the pandemic. As we reported in 

, the pandemic posed an opportunity for sponsors and CROs to demonstrate a commitment to front-line site staff and study participants.Financial support and protocol flexibility were most often requested by site staff facing economic uncertainty and difficulty in obtaining supplies, getting labs, and conducting visits.

Based on results of this recent survey, it appears that many study sponsors were listening to these calls. PIs and SCs rated sponsors overall as doing a middling job in their response to the pandemic, with a mean rating of 4.3 on a 7-point scale. These ratings did not differ significantly by type of site, geographic region, or number of ongoing clinical trials. Sponsors were given higher ratings for their willingness to create protocol amendments for conducting home or remote monitoring, and for home delivery of investigational medications. As one PI from North America said, “I think they did what they could. Let’s not forget that this pandemic took us all by surprise.” Ratings of sponsors’ willingness to deliver other forms of support was less favorable.

For example, 43%–55% of respondents said that sponsors made no attempt at all at providing assistance. As shown in the graph, there were several areas where this lack of response was notable:

Increasing the budget for home/remote monitoring

Increasing the budget for study subject travel

Increasing the budget to retain study participants in ongoing trials

Financial concerns and budgetary issues are clearly still plaguing site staff. For example, while sponsors made protocol adjustments for home delivery of medication, financial allowances were not made. “They should improve their budget to send medications to homes and encourage safe transportation,” said one PI from South America. With nearly 40% of respondents noting that COVID-19 has negatively affected the finances of their clinical trial site, it is a definite cause of concern for sponsors moving forward.

What lies ahead with clinical trial development is as uncertain as any facet of life in this pandemic era. But, as described in a perspective recently published in the 

, site staff are discovering adaptations that can benefit the industry beyond just those trials of COVID-19 treatments. We can continue look to what has and hasn’t worked in the past six months to help inform changes in the coming months. Some lessons and needs remain timeless and persistent:

Modifying the requirements for in-person visits is a relief on CROs, site staff, and patients alike and can help substantially in a trial’s ability to stay the course

With the healthcare industry competing with the general population for PPE, sponsors and CROs can help sites acquire the materials needed to safely conduct trials

The financial effect of COVID-19 shut-downs and delays may have yet to be fully experienced, but sponsors play a pivotal role at helping to mitigate the damage now

Honest, transparent, and timely dialog between sponsors, CROs, and site staff may be the linchpin in maintaining the relationships needed as trial programs look to continue or start in 2021

Surveys like this, and the insights gleaned from them, are a step toward fulfilling that later need. 

To read the full results report and uncover other ways sponsors can help, visit 

The authors would like to acknowledge Kristie Walters for her editorial assistance in preparing the article.

Articles

Lessons from six months of conducting clinical trials during the COVID-19 pandemic

Where Do We Go From Here?

	As the COVID-19 pandemic wears on, the 

FDA continues to update the latitude it granted

 to sponsors in the hopes that protocol modifications can keep trials running while ensuring the safety of site staff and trial participants. But has that flexibility been embraced and executed upon by sponsors? Are site staff and trial participants getting the support critical to maintaining the safety of those involved and the integrity of the data generated?

	To find out, we continued our survey series aimed at uncovering the specific 

 and trial participants during the COVID-19 pandemic and the 

Figures 1 through 3 detail the makeup of the 255 study personnel who responded to this third survey. 

	Of the PIs who responded, most were in cognitive specialties, such as psychiatry and cardiology (Figure 4). 

	From this large number of respondents across the globe and from a mix of study site types, several take-aways are clear:

		The vast majority of sites are experiencing a financial decline due to the pandemic, making flexibility much more critical

We would like any studies currently on hold to get started. We are using proper PPE and cleaning techniques to keep our patients and employees safe. Our site cannot survive if studies don't begin until next year.”

		Study site staff believe there will be fewer in-person visits in the future and that it will take 6 months or more for trials to return to pre-COVID-19 levels. One respondent noted, 

ight now we are doing remote visits and are now starting to see some participants in the clinic. State rules and our institution’s guidelines determine these practices.”

		Site staff need sponsors to allow protocol changes that permit remote site visits and they need help from Clinical Research Organizations (CROs) to make them possible. An investigator wrote, 

Stay in touch. Work with us on remote monitoring visits. Provide information on how other sites have been successful in getting studies back up and running.”

	Change is critical to overcoming financial losses

	The financial loss from the COVID-19 pandemic is undeniable. A whopping 74% of clinical trial sites have experienced a financial decline since the pandemic started (Figure 5). Perhaps relatedly, a quarter of sites have less staffing now compared to before the start of the pandemic, with differences experienced across site types (Figure 6). Only 6% of sites have hired more staff during the pandemic. 

	According to survey respondents, the financial situation may not change for some time to come. On average, respondents believe it will take 5 to 6 months before the number of clinical trials being activated will return to pre-COVID-19 levels (Figure 7). The estimation changed by site location, where sites in eastern Europe expect pre-COVID-19 levels to return significantly sooner (4.2 months) than sites in all other regions.  

	One source of hope for an increase in the number of trials comes from specialty sites with potential COVID-19 focus who are expecting to run trials related to COVID-19. Over a third of staff from these types of sites are running or planning to run COVID-19 related trials, with 77% expecting traditional site visits and 37% noting home visits. 

	Virtual visits are the future of clinical trial research

	The keys to continuing clinical trial programs amidst the pandemic may be to scale up virtual or remote visits, giving any relief possible from the financial effect of the pandemic. Across the board, the majority of study site staff believe the number of in-person site visits will decline. In fact, over 50% of site staff requested more non–on-site visits. Academic sites and non-academic hospitals were significantly more likely to request this change from sponsors than were other clinical trial site types-nearly 70% of hospital sites responded as such to this open-ended question. The desire to convert to remote visits was not affected by the number of active trials being conducted at a site. 

	What will patient monitoring look like in the future? Most respondents felt telephone-facilitated visits will increase more than other visit types moving forward (Figure 8). Technology is key to making these remote site visits possible. Therefore, it is not surprising that 65% of respondents who expected an increase in remote monitoring also expected a greater use of automation and technology. Academic and research-only sites had a significantly higher expectation for higher levels of automation than all other sites, as did sites with >10 active trials.

	One of the key concerns around the use of technology and remote monitoring is the quality and integrity of the data generated. Of site staff who expect an increase in non-traditional site visits, the vast majority felt confident in the quality of the data obtained from remote and virtual visits. Confidence in remote-collected data did not change by site type. However, 20% of site staff want to be re-assured of data integrity as we move into more remote monitoring. Sponsors cannot overlook such a skeptical group of site-staff customers when recruiting sites for new trials.  

	Sites to sponsors: protocol changes are a must

	To make remote visits possible, site staff need flexibility in the form of protocol amendments. Fully three-quarters of site staff requested that sponsors provide protocol changes to allow for remote site visits-and this is a priority for hospital-based sites in particular. 

	Site staff had other requests for sponsors as well, many of which may help not only maintain trial programs but relationships with site staff as well:

		Study medications sent directly to trial participants, particularly at academic sites

		Budget to execute those changes, especially at research-only sites

		Help in acquiring personal protective equipment (PPE) and COVID-related supplies

	Interestingly, several sites not immediately feeling negative effects from the pandemic do not want to be lumped in with sites that are more largely affected. This shows that the effect of the virus is as unique to each site as it is to each patient. 

	Site staff echo the call to CROs for support in executing remote visits. When given an open-ended question, a third of site staff specifically responded that online monitoring and remote communication would be most helpful in assisting with virtual or remote visits. Similar to responses about sponsor support, site staff indicate a basic need for better communication and the willingness of CROs to be more flexible and open to change.

	At the beginning of the pandemic, study sponsors were quick to hit pause on activating new trials. As time goes on and the idea that COVID-19 is something we need to live 

, sponsors need to turn their effort to the protocol amendments and creative solutions that will help study site staff keep participants safely engaged in trials while maintaining the integrity of the data.

	For the third time in this series, study site staff have volunteered specific suggestions for how to make this happen. Some suggestions, like home delivery of trial medication, are born from the unique situation presented by this global pandemic. Others should be perennial, like effective and timely communication. The FDA has issued guidance to model that modifications like these are, in fact, possible in a segment of the industry that is often viewed as rigid and guarded to change.

	What is also enduring is the need for unbiased research that can uncover the true needs of healthcare stakeholders, like those 

detailed in this study report and the reports of the previous two surveys

. It is ironic that clinical development aims to discover information that supports change, whether it is a new indication or a new product to help patients in need. Especially during this pandemic, there is a need to turn that objective inward and help those who make those trials possible.

In the third of their survey series, Clinical SCORE uncover the specific hurdles faced by site staff and trial participants during the COVID-19 pandemic and the support needed to overcome them.

Following the FDA: Sites Want Flexibility From Sponsors

	As of May 22, the COVID-19 pandemic has resulted in more than 325,000 deaths globally, according to the World Health Organization. The coronavirus has put an unprecedented strain on every facet of the healthcare system, including clinical trials. To get a first-hand, uninhibited account of these effects, Clinical SCORE is conducting a series of surveys with site staff that aim to uncover the needs and potential solutions that could be employed by sponsors and CROs. 

	The series began in late March when the coronavirus pandemic was still only getting started. 

, demonstrated that the pandemic was affecting site staff in ways beyond just social distancing. Despite the fatigue of study site staff, even in those early weeks, there was a determination to stay the course. To fulfill that, site staff looked to sponsors and CROs for support.

	Clinical SCORE repeated this global survey in early May. The 

, described here, demonstrate that requests for site staff support and pleas for understanding their burdens are growing, yet unchanged is their commitment to maintaining trial activity. The big take away: investigators and other site staff are begging sponsors and CROs to match their tenacity to soldier on.

	For this second survey, trial respondents were located in 38 countries across the globe. Of the site staff from 226 sites who responded to the 15-minute survey, 119 were also included in the original survey. Noting a decrease in response rate of more than 50% in the US and a slightly smaller decrease in responses from academic site staff between the two surveys, Clinical SCORE followed up by phone to find that at least a portion of these sites had temporarily closed. 

	This trend was particularly notable in academic institutions. In fact, none of the staff from academic sites in Italy, France, and Germany who responded to the first survey responded to the second. There was also a decrease in the number of study coordinators who responded overall-51% of the total sample in survey 1 compared to 39% in survey 2. It seems that academic sites may have closed to divert staff, or staff have been furloughed or laid off.

	There was also a significant reduction in the number of active trials at responding study sites. The mean number of active trials at sites fell to 10.9 in survey 2 from 18 in survey 1. Two thirds of trials awaiting activation were noted as being substantially impacted by the virus. In this second survey, 51% of trials not yet enrolling study participants were postponed compared with 36% in March, and 49% of respondents reported suspending visits for these trials, compared with 42% in survey 1.

	Looking at the impact of COVID-19 on active trials, the staff at free-standing research sites were more likely to report a substantial impact in survey 2. While academic site staff were less likely to report a substantial impact, the notable decrease in response rates from staff at these sites suggests that some are not currently operational. 

	Trial staff and study participants growing weary

	In terms of staff burden, the situation is yet to improve. Site staff in Western Europe may be feeling this affect more acutely, as 41% now report staff being diverted to care for patients with COVID-19. The staff stress is especially manifest in managing labs and the supply chain, which accounts for the largest cause of the negative impact on their time. Staff are also dealing with the economic consequences of the pandemic, a stressor reported by 41% of site staff in survey 2 but by only 26% in March, with the largest increases seen from those at clinical practices and free-standing research sites. 

	Keeping up with changing protocols and procedures is also burdening staff, though these protocol amendments may be necessary, as an increasing number of study participants are unable to attend study visits in person. Across trial site types, there was an increase from 48% to 64% in the inability of study participants to attend on-site visits. Accordingly, there was also an increase in the number of trial staff reporting a conversion to virtual visits since the first survey (36% vs 48%). This holds true across study settings and regions. These virtual visits may be a critical means of maintaining trial activity, as 20% of survey respondents indicate that they feel study participants may be too nervous to leave home, even after travel and such restrictions are lifted. 

	These results heighten the urgency demonstrated in the previous study: sponsors and CROs need to modify trial designs to include more virtual visits and, when required, amend protocols to retain study participants in their trials. This second survey shows an uptick in the percentage of site staff requesting financial assurance and support from both CROs and sponsors, underscoring the financial impact of the pandemic on study sites. 

	As in March, only 20% of site staff believe that CROs and sponsors are being proactive in making the adjustments needed to continue trials during the pandemic. The results of this second survey spotlight the divide between sponsors responding to these needs and those that are not allowing for this flexibility. 

	Nearly twice as many investigators and study coordinators asked for modifications like alternative visits and additional time from CROs in this second survey as compared to survey 1 (44% vs 27%). Some sponsors seem to be meeting these demands, but others are not. Forty-five percent of study site staff requested that sponsors enhance communications, including providing guidance on safety and alternate visits, compared to the 33% of site staff who requested this in the first survey and the 16% of site staff who requested better communication from CROs. 

	With the consistent declines in active trials and on-site visits, the increase in staff burden and economic concerns, and the need for communication and support, it begs the question: what more can sponsors and CROs do to meet the needs of the sites they depend upon to continue their clinical trial programs? Perhaps a better question is, how can sponsors and CROs respond to the resounding calls from trial sites?

	Listening to and learning from trial staff is critical to building the protocols that allow trials to continue in crises like the coronavirus pandemic. It is also an essential step toward building the trusting relationships that encourage participation, despite the challenges and demands of these situations. The difficulty lies in the fact that trial site staff may be reluctant to speak up when asked for feedback, fearing that honesty could jeopardize the sponsor relationship. 

	Third-party researchers are helpful in soliciting the whole truth-the candid criticisms and appeals that can help sponsors, CROs, trial staff, and study participants learn how to maintain this critical milestone in the development of life-saving treatments. The insights gathered in this survey series are a start, but it is ultimately up to sponsors and CROs to forge the way forward.

Clinical SCORE would like to thank Kristie Walters for her copy and editorial support.

Results from a Clinical SCORE study shows investigators and other site staff are begging sponsors and CROs to match their tenacity to soldier on.

Listen, Learn, Respond: Pandemic Presents a Critical Time for Sponsors and CROs

	Clinical trials are frequently mentioned in the flood of headlines about the coronavirus global pandemic but often in context of new treatments, vaccines, or testing for COVID-19. Somewhat overlooked are the ongoing or future clinical trials of much needed treatments for patients with underserved or poorly managed diseases. 

	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. 

 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. 

	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.

	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.

	For more details on the survey results, including specific suggestions from sites to sponsors and CROs, click 

The Effect of COVID-19 on Clinical Trials: Insights From the Inside.

A global survey of clinical trials sites, conducted by insights company Clinical SCORE, revealed how deep the effect of the COVID-19 pandemic is and how sponsors can help sites stay the course.

Supporting Clinical Trial Sites During the COVID-19 Pandemic

	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.

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

	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. 

	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.

	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. 

	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.

		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.