OR WAIT null SECS
© 2023 MJH Life Sciences™ and Applied Clinical Trials Online. All rights reserved.
Applied Clinical Trials
Results from a Clinical SCORE study shows investigators and other site staff are begging sponsors and CROs to match their tenacity to soldier on.
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. Results from the first survey, as described in Applied Clinical Trials, 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 results, 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.
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.
Blaine Cloud, PhD, is Senior Vice President, Gary A. Kaplan is Vice President, Analytics; Ross Weaver, PharmD, is the President all with Clinical SCORE, LLC
Clinical SCORE would like to thank Kristie Walters for her copy and editorial support.