Thanks for stimulating the conversation.
We continue to support "essential studies" (i.e. moderate to high direct benefit to research participants) and enroll patients to these studies. We continue to activate new studies to be able to have these open and ready when we recover from COVID-19 surge. After careful review of the FDA's position, DHHS announcements and benchmarking of NCI Designated centers we developed a decision aid to guide our researchers and study teams.
We have issued guidance to our investigator community which includes leniency to:
We have also enacted direct currier of investigational oral agents to patient's home. This allows us to minimize exposure to patients and continue treatment while maintaining chain of custody of the IP. To protect our staff we have developed a rotating on-call schedule which includes a coordinator, manager and biospecimen technician and have shifted to telecommuting for all other team members (i.e. regulatory affairs, finance, etc) under an approved workplan. We are concentrating our efforts on education, skills development, standardization to continue to derive value from our workforce and make meaningful contributions toward our goals. Like many others, we have a no visitor policy and have enacted remote monitoring visits with direct access to EHR and use of other software systems for research documentation housed outside of the medical record (i.e. logs, DARFs etc.). we have seen a mixed response from our Industry partners with some halting enrollment.
I think these actions are probably consistent with other like centers, but I am interested to learn what others are doing and whether the research volumes have been significantly impacted as our clinician's role in the care for cancer patients (i.e. inpatient consults, rounding to alleviate hospitalist burden) continues to increase.
Therica Miller, MBA, CCRP
Director of Clinical Research
Hartford HealthCare Cancer Institute | Memorial Sloan Kettering Cancer Alliance
560 Hudson Street , West Wing, ERD #523, Hartford, CT 06102
P: (860) 972-4597 | F: (860) 545-3155 | E: firstname.lastname@example.org
Find available clinical trials HERE
Clinical Trial Referral Line: (860)-972-4700
Thanks for sharing your strategies! It sounds like your site has made a lot of adjustments to adapt. Two questions for you. Would be willing to share the decision aid your site developed? (No pressure, of course!) I think it could be really helpful to other sites who are also working to reprioritize. The other question is whether you have any insight into how these changes are impacting your patients? Have they provided any feedback?
I'll note that on a high-level, I think what you've noted aligns with the findings from a recent site survey ASCO did to understand COVID-19's impact on research at sites. The findings have been submitted for publication, so hopefully we'll be able to share details from the survey soon. I am curious to hear what strategies other sites and researchers are using though and whether they feel that they're effective!
First, thank you for sharing some of the great work that you are doing with our research community. As you are witnessing, we are going through some significant changes in how we conducted clinical trials and how we work to protect our patients, our staff, ourselves, and our families. No doubt some of the measures that we are taking now will be adopted directly into trials in the future. Not all of the changes will be bad.
We have adopted many of the same measures that you have adopted. And yes, research volumes have been adversely affected by the pandemic at our institution. Some of this is driven by the fact that trials we were accruing to have been closed down and some of the decreased volume is a function of less patient volume in general. Still, we are committed to keeping our research staff whole and not wanting to see them suffer any financial hardships. We are independent and our physician owners have made this commitment. I am curious how institutional groups are handling the research staff as productivity decreases. Has anybody been furloughed or let go?
Please continue to post as we can learn from each other and support each other. I would encourage others who are reading these streams to please also post. As a teaser, we just completed a paper for JOP specifically addressing some of these issues as discussed. It was accepted today and I do not have a publication date as yet. We will post as soon as we have it.
Keep up the great work. Our work is very important and it is committed individuals such as yourself who are the silent champions of clinical research!
David M. Waterhouse, M.D., MPH Chair ASCO Research Community Forum Co-Chair, Department of Clinical Research Oncology Hematology Care Cincinnati, OH 45242 Office (513) 751-2273 Cell (513) 673-1441 email@example.com