As we enter the third month of the COVID-19 pandemic (June 2020), Clinical Research IO was interested to see whether there have been any measurable changes to the landscape of remote monitoring.
When we interviewed research sites a little over a month ago, we found that many sponsors and clinical research organizations have implemented some form of remote monitoring. On one end of the spectrum, some clinical research associates are conducting short phone calls to discuss EDC entries or ensure that investigator site files are up to date. In these cases, monitors have no access to source documents and no source data verification is performed. On the other end of the spectrum, some CRAs are requesting that sites scan and email/fax/overnight source documents. Given the different ways remote monitoring is being implemented, it is obvious that sponsors and CROs have not yet standardized this process. We also found that despite many sites being eSource and eRegulatory enabled (with solutions such as CRIO), monitors wanted to resume on-site monitoring as soon as sites and local regulations allowed, with the earliest date reported as of May 15th.
So… have there been any significant changes since then? Unfortunately, the answer is no.
According to a physician-associated research site in Massachusetts, monitors from both large and small pharmaceutical companies have started to reach out about their site’s capability to host on-site monitoring visits in late June. Despite conducting remote visits (i.e., WebEx meetings with no access to source documents and therefore no source data verification) in the height of the pandemic, it seems that the preference for on-site monitoring visits still remains.
In a recent podcast by the Society for Clinical Research Sites (SCRS), Michael Jay, the Director of Special Projects spoke with Lauren Litzinger, the Process, Standards and Signal Interpretation Group lead at Pfizer.
Like many other large pharmaceutical companies, Pfizer usually relies on on-site monitoring visits to maintain oversight of their sites and studies. If remote monitoring is implemented, it is used to supplement the on-site visits, but is not performed in lieu of them. As COVID has imposed local government and site-specific restrictions, their monitors have been unable to perform on-site visits and the company has had to explore new remote options that comply with current regulations. For example, Pfizer has prioritized gaining access to electronic medical records and transitioned to performing remote review through technology solutions like WebEx with restrictions such as no recording to protect data privacy.
When asked whether Pfizer will be maintaining the developments made even after COVID-related restrictions are lifted, Litzinger advised that they hope to continue using any successful options going forward. She then mentioned that Pfizer is “assessing cloud-based solutions, but is not yet at a place to implement it.”
CRIO also spoke with the vice president of a leading IRB. According to him, although sponsors are saying “remote, remote, remote,” there have not been any major developments. That said, in his conversations with several big pharma companies, he has suggested that sponsors fund eSource/eRegulatory systems for sites, and “the idea seemed to resonate.”
Although the industry has not yet seen the anticipated, permanent transition to remote monitoring, there have been more indications that it will become mainstream in the coming years. As the vice president of the IRB said, “The needle may be moving, but as with most things in pharma, the movement is slow.”