The COVID-19 pandemic has caused an enormous disruption in healthcare priorities and staffing, and as restrictions on people’s movement have increased, clinical research sites face unprecedented challenges to adjust studies and patient engagement accordingly. The FDA has provided guidance to support ongoing continuity and response efforts, wherein the safety of trial participants is paramount. It is critical that sites proactively communicate to their participants about study changes that could impact them.
The first step sites should be taking is to reach out to their sponsors or CROs. Sites should consult with these members to learn what changes need to be made to current or pending studies and develop a plan that will effectively and efficiently keep participants informed.
During this consultation, PIs and sponsors/CROs should determine if hitting the “pause button” on a trial is feasible — for example, studies that do not provide an immediate benefit, impart necessary care for a patient or cannot be done remotely. If the study cannot be suspended, the team should consider where and how visits will continue be conducted for participants. Can visits be done:
- Virtually by way of phone or video calls, and where investigational product can be self-administered or administered by a caregiver
- In-home via appointments with a coordinator
- At satellite locations (i.e. drive-thru visits or local imaging sites), where foot-traffic and potential virus exposure is reduced
- At the site, with enhanced COVID screening procedures implemented
Next, sites need to address patient consent and the calibration of documentation procedures. Re-consent, while not a regulatory term, is a means of updating a participant about study changes, and something sites need to pay close attention to as they work to address new COVID-related changes. Sites can provide a revised consent form but may also elect to make the process of reconsent easier by way of an addendum or memo, or verbally by way of phone or Skype. It could even be a single signature page that is sent to the participant that is signed and returned, whether electronically or by mail. SACHRP encourages that the approach that is least burdensome approach for the participant be used. Additionally, ask your sponsor or CRO if they can provide virtual support staff that can help alleviate some of this administrative strain.
After this, sites will want to begin the process of communicating directly with their patients. It’s important that staff keep the lines of communication open to inform participants of all changes to the study that will impact them, to convey what will remain the same and to mitigate any concerns or fears they may have. It’s also important that staff engage with patients in a human way. For example, if the study is being suspended because it is deemed non-essential, say instead that until the complications of the coronavirus subside the study is being paused to protect their health and the health of others.
Share important information with participants, like when and where their next appointment will be and what they should expect for COVID screening. Also, keep in mind family members or caregivers that may typically accompany a patient — if these additional people are not allowed on site as a matter of social distancing, make sure they are informed ahead of time.
Finally, remember that at a time like this there will be more questions, by participants and their caregivers, than readily available answers…which can be overwhelming. Site staff should make the time to be accessible and ready to keep the lines of two-way communication open regularly. But consider what educational resources and patient advocacy groups participants can access to supplement staff interaction; support a sense of community in the days of social distancing. If sites do well to quickly form a response plan with their sponsor and facilitate regular communication with their participants, they can greatly minimize the loss of progress to their studies while the healthcare system tackles the COVID-19 emergency.
Astor, L. (2020, March 19). FDA Issues Guidance on Conducting Clinical Trials During COVID-19 Pandemic. Retrieved from https://www.targetedonc.com/news/fda-issues-guidance-on-conducting-clinical-trials-during-covid19-pandemic
FDA. (n.d.). Guidance for Industry, Investigators, and Institutional Review Boards. Retrieved March 18, 2020, from https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-pandemic
Pollard, V. (2020, March 24). FDA Offers Guidance on Clinical Trials During COVID-19 Pandemic. Retrieved from https://www.natlawreview.com/article/fda-offers-guidance-clinical-trials-during-covid-19-pandemic
WCG. (2020, March 18). Clinical Trials in the Era of COVID-19 Weekly Webinar Series: Part 1. Retrieved from https://www.wcgclinical.com/events/covid-19-webinar-series/
Bio-Optronics is providing this information as a convenience to clients based on its own research. Before taking action, readers should verify these comments are in compliance with the most recent regulations or official study guidelines.