COVID-19 and Clinical Research
How do you think this pandemic might change our industry for the better?
At this point, you have surely felt the sting of the Covid-19 crisis. We sincerely hope that inconvenience has been the only symptom you have suffered. Our CRAs have told us of their issues with travel, how their sites have been restricted and have canceled monitoring activities, and how their children’s schools have been closed creating an issue with childcare.
With approximately 318,900 clinical trials enrolling and/or providing care world-wide, the ramifications to the clinical research industry will likely be altering – permanently altering. We would like to believe that many of those changes are ones that will make our industry stronger. Will this pandemic force the Clinical Research Industry to embrace Risk Based Monitoring, Decentralized Trials, or Hybrid Trials?
While most of our Monitors have been restricted from travel, they have reported that some sites which had never previously allowed remote monitoring have reversed policies, opening access to databases allowing CRAs to monitor during this crisis. Other sites have been faxing or emailing redacted source documentation to the CRAs so monitoring of critical data can still be performed. What are some of the changes you’ve encountered so far?
We want to hear from you. How have you and your clinical teams been addressing the current crisis in a way that may positively impact our industry’s efficiency moving forward?
For those of you who haven’t seen this yet, I am attaching a link to the current FDA guidance for conducting clinical trials during these crazy times: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-guidance-conducting-clinical-trials
Many industries are feeling the impact of COVID-19 and ours is absolutely no exception. I am finding, however, that there are ways we can make the best of our time. While we are obviously not able to perform all of our tasks as we normally do, I am finding time to adjust in different positive ways. I am able to do more remote work than I would normally do and I see that it may indeed be a change in our industry. Sponsors may find the remote model more cost effective while retaining the focus of our work. I am also finding that spending quality time with my family as a pleasant result of this. Normally with 80-90% travel I miss the time with my family and with the chaos of the virus, I am finding time to do things that I miss doing. It is different than the norm, but in some ways its very positive and I, for one, am trying to make the best of it.
Thank you, Kyle! Yes, we do feel that the industry will come around to see that the remote model can be more cost effective and efficient, and, as you said, it can allow for more time with family and friends–work/life balance.
Kyle I agree, I think sponsors/CROs may find this more cost effective and see the benefit of the work life balance it provides their employees. I was on the road for 20 years as a CRA and have been working predominately at home this past year and it has been great. I have remotely monitored with several progressive hospitals in the past who allowed CRA access to their EMR after security checks. I was able to get much of my work completed prior to the visit and have a much more targeted visit when onsite. It will take work from our industry and the sites as many don’t realize the technology for remote access has been in place for at least 10 years.
As far as the whole family home, It’s great. I enjoy my new 11yo coworker form 9-noon and cherish the quiet when I can get it. I just alter my hours and get up before they do and work a little later after supper or once everyone is asleep.
I certainly appreciate the break in travel, and have had sites willing to share remote EMR access to allow for remote SDV; unfortunately my company does not allow this type of review, in addition to emailed correspondence containing redacted information, so that has been a challenge.
Leandra, thank you for this note. I was speaking with a Director of Clinops at a Sponsor yesterday and she said that Veeva Vault is offering a free version of their tool for sites who have never allowed remote access before. Apparently the installation is quite simple and enables the sites to send source documents over electronically instead of having to scan/email or scan/fax redacted source documentation. She is hopeful some of those sites who haven’t been willing (or able) to provide remote access in the past will embrace this opportunity.
I, too, feel that the response to this crisis will accelerate the many changes that are spreading across our industry. Changes from remote monitoring, to exclusive use of EMRs in major medical center, to risk-based monitoring, to greater standardization in data format and specialized systems for data analysis.
The benefits will be better life-work balance for some and loss of personal relationships for others. Our working relationships will change and the CRA may find that some of the perks of the job are lost. I think the deciding factor will be dependent on the CRA and his/her needs both professionally and personally.
I think that remote monitoring will move the industry closer to more remote and less traveling.
This is certainly more cost effective and produces a better work/life balance.
Pam, I agree. While I do understand there are certain things that have to be done on site, I also believe our current circumstances will change the “face” of our industry in a way that will drive more remote monitoring (as appropriate, of course). Thank you for your feedback, Pam. I hope you and your loved ones are staying safe and healthy.