Clinical Trials Have Largely Re-Opened, Per Clinical Research IO’s Survey

At the beginning of May 2020, many of the larger pharmaceutical companies released their first quarter financials and shared their plans to open up research amid the ongoing coronavirus crisis. Determined to return to near normal operations by the end of the year, sponsors said they would begin to lift enrollment holds and initiate new studies.

According to a post in the WCG Trial Insights Series (which surveys over 1400 sites across 29 countries):
1. 37% of sites are now open to enrollment, and this number is predicted to continue increasing.
2. The number of sites that anticipate restarting screening in the next month has increased to 75%.

To form a more developed picture of trial restart at the site level, Clinical Research IO surveyed 91 research sites within the United States.

Of the 91 sites, 48% identified as sites affiliated with a physician practice, while 39% identified as freestanding sites. 52% described themselves as multi-therapeutic, with the rest describing themselves as specialists, led by CNS (14%) and Dermatology (12%).

Survey results revealed the following important insights for clinical trial sites:

1. 89% of clinical trial sites are open to enrollment across their entire study portfolio

When sites were asked what most closely describes their current policy on enrolling new patients, all respondents indicated that they have started screening and enrolling again to some degree. Amazingly, 89% reported that enrollment is open for all ongoing studies. The remaining 11% of sites, which represents the minority, said they are generally open to enrollment, but may choose not to open certain studies.

2. 76% of studies (across clinical trial sites) are currently open to enrollment

Clinical research sites were asked to list the number of studies 1) currently enrolling, 2) on enrollment hold but scheduled to re-open within the next 2 weeks and 3) on enrollment hold and not scheduled to re-open within the next 2 weeks.

Across 91 sites, a total of 637 studies are being conducted. Of these studies,

76% of studies are currently open to enrollment,
12% of studies are currently on an enrollment hold, but are scheduled to restart within the next two weeks, and
13% of studies are currently on an enrollment hold and have not yet been scheduled to restart in the next two weeks.

Concluding Thoughts from Clinical Research IO’s Clinical Trial Site Survey

When comparing the percentage of studies open to enrollment in our survey (76%) to that of WCG’s (37%), our result is substantially higher. This could be due to the relatively high proportion of freestanding, more entrepreneurial research sites as opposed to academic centers and health systems, which may be taking a more cautious approach to enrollment. It could also be that sites in the United States are on the earlier end of re-opening. In addition, some portion of research sites may have discontinued operations and that portion may be included in WCG’s figure.

Our survey does indicate that for sites who are ready and willing to re-open for business, most sponsors are willing to green-light their studies. Based on discussions we’ve had with several site directors and principal investigators, it appears that most sponsors are taking a risk-based, research site-by-site approach to re-opening their studies.

For example, a site in Louisiana and a site in Massachusetts said that several sponsors are using an electronic survey to gauge site preparedness to re-open. Green-light documentation will be sent only after the site has been verified as “ready” by the sponsor.

In determining whether a site is fit to screen and randomize patients again, study monitors and sponsors will be taking into account some or all of the following factors:

Local/state regulations (e.g., stay at home mandates, curfews)
COVID data over the past few weeks for the region that site is located
Ability to conduct onsite monitoring visits
Ability to see patients on site
Ability to see patients via alternative methods such as telehealth, phone, home visits, care visits
Participant willingness to return to clinic for visits
Ability to receive IP shipments
Ability to process blood and ship to central laboratories
Monitor access to electronic medical records
Availability of site staff

If your site is still waiting for enrollment holds to be lifted, continue communicating with your study monitors. Let them know that your site is open and ready to go, and provide examples of what your site has done to prepare for the re-opening. Additionally, use this time to take stock of your site (i.e., levels of PPE, make updates to SOPs, ensure that regulatory documents are updated & filed, etc.) and prepare responses for potential site surveys that sponsors may send.

This survey was fielded by Clinical Research IO from June 22-June 26, 2020.

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Clinical Trials Have Largely Re-Opened, Per Clinical Research IO’s Survey

Survey results revealed the following important insights for clinical trial sites:

1. 89% of clinical trial sites are open to enrollment across their entire study portfolio

2. 76% of studies (across clinical trial sites) are currently open to enrollment

Concluding Thoughts from Clinical Research IO’s Clinical Trial Site Survey

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