To understand how the pandemic is affecting clinical trials, Clinical SCORE conducted a web survey with their trial site database.
In response to the COVID crisis, sites have implemented some or all of the following procedures:
- Virtual visits, drive through visits, and/or telephone visits
- Sending letters to patients promising flexibility around patient needs, including home visits
- Increased sanitation/cleaning processes
- Home delivery of study medication
- Longer hours to keep number of people on site low and to provide additional hours for patient visits
In terms of the number of active studies that each site has,
- 38% have 1-5 active trials,
- 31% have 6-9 active trials, and
- 31% have 10+ active trials.
This means that the average number of active trials per site is around 13. Clinical SCORE did not include the average number of active trials that sites had prior to COVID for comparison.
Sites indicated the following reasons for delays to studies that are still enrolling and randomizing participants:
- Patients are unwilling to visit site
- Screening is on hold and/or doing virtual visits
- Trial activities have been suspended by sponsors
- Delay is from sponsor/CRO but the reason is unclear
- Protocol is being amended by sponsor
- Other unspecified reasons
Between larger and smaller research institutions, the larger institutions such as academic and non-academic hospitals have felt the greatest impact so far. Free-standing research sites and practice-based sites appear to be experiencing less impact and Clinical SCORE notes that this may be because these sites heavily depend on clinical research for business and revenue.
The survey also revealed that regardless of institution size, site staff are being affected. In order to continue visits, site staff must adjust to changes to trial operations, different salaries, lockdowns/government restrictions and equipment shortages. At least 4% of sites indicated that there is a high level of anxiety or fear amongst staff. One of the most drastic changes for trial staff in academic hospitals has been the mandatory switch to COVID patient care.
Note: if you are a site director, learn how this site’s staff work remotely over 50% of the time… even before COVID-19!
As the crisis continues to unfold, sites are calling on CROs and sponsors to provide further assistance. Some of the requests include increased and better communication without overwhelming sites with calls/emails, working together to conduct patient visits using alternative methods and making adjustments to protocols to accommodate COVID related deviations.
Clinical SCORE also reports the following important findings:
- 92% of trials are being modified to ensure continuity
- 36% of trials are switching to virtual visits
- 70% of sites have stopped on site monitoring visits
Overall, sites have remained committed to keeping clinical research going and have demonstrated that they can quickly adapt to an ever evolving situation. Unfortunately, if the pandemic continues, over a third of trial sites have indicated that they may need to close down. If this becomes a reality, the slowdown in new drug development will be much more extensive than previously predicted.
The survey was fielded from March 26 through April 1, 2020 and included a total of 363 research sites across 42 countries.