In the latest segment of the ClinEdge COVID-19 webinar series, Christian Burns and Al Peters discuss site-wide responses to the pandemic and offer insight on how sites should prepare for the upcoming wave of study restarts.
View Your Clinical Trial Site From a Business Perspective
While many have referred to the COVID crisis as “an unprecedented time”, Christian Burns, President of ClinEdge, says change is not unprecedented from a business perspective. Burns noted that many sites have actually become stronger as they have been forced to reinvent themselves and is exemplified by the agile responses that sites are taking to continue research (i.e., alternative methods for study visits, new methods for data collection, decision making by PIs, SOPs). Al Peters, President of BTC Network, adds that individual roles within sites have also evolved. For example, the niche role of a coordinator has expanded to include additional responsibilities such as IP delivery. Knowing that COVID will continue to affect us in the coming months, it is important that sites continue to make adjustments accordingly.
On the subject of study financials, Peters recommends sitting down weekly to determine where employee time is spent and identifying/categorizing expenses. By creating an outline, sites can renegotiate contracts and provide clear reasoning to sponsors. Some common areas for renegotiation include remote monitoring, protocol amendments, unscheduled visits and increased/logistical management for each visit.
What should research sites continue to do as studies restart?
In the next few months, many studies will open. Sites should use this time to reassure sponsors of their status and of the precautions in place to carry out research (i.e., site structure, availability of staff, how visits are being handled, etc). According to Burns, most sponsors are trying to reach original enrollment goals and will need to add on sites. Get in touch with sponsors and provide an update before they ask. Be sure to emphasize how your site is unique (e.g., 4-5 areas that your organization does well or will do well) as they will receive many requests.
Another point of focus for sites should be patient communication. Burns suggests creating a weekly communication plan that involves multiple forms/channels (text, phone calls, emails, images) and can be easily customized for any study. Messages should be educational and can include how your site is addressing/will continue to address COVID, site updates or what to expect upon arrival to site. Social media can also be used tactfully to demonstrate to patients that your site is open and taking precautions to ensure their safety. By maintaining patient engagement, sites can create a more trusted brand for themselves.
Watch the full webinar.
- Al Peters, President of BTC Network
- Christian Burns, President of ClinEdge