Where Do We Go From Here?


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

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, published in April in Applied Clinical Trials, painted a bleak picture. Subsequent surveys showed clear challenges and emerging needs, with strong calls to action 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.

Trial activity is on the rise

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%.

* Rated on a 7-point scale

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 May and July in Applied Clinical Trials, 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:

  • Assistance in finding replacement labs
  • Providing necessary supplies and PPE
  • Increasing the budget for home/remote monitoring
  • Increasing the budget for study subject travel
  • Increasing the budget to retain study participants in ongoing trials

* Rated on a 7-point scale.

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.

* Rated on a 7-point scale.

Lessons for the future

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 New England Journal of Medicine, 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:

  1. Remote monitoring: 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
  2. Material acquisition: 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
  3. Financial support: 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
  4. Communication: 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 ClinicalSCORE.com.

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

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

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