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.