Coronavirus is disrupting clinical research at sites worldwide. To further understand how COVID is affecting research at a site level, CRIO connected with Dr. Marcus Stone, the Director of Clinical Research at The Spine Institute of Louisiana Foundation, the research arm of a broader spine institute. The Foundation was created solely to identify and test innovative spine treatments and cutting-edge technology to improve their patients’ health outcomes.
CRIO: What measures have been implemented in Louisiana in regards to coronavirus?
Dr. Stone: In addition to a “stay at home” order, Louisiana has an order in place across the state that prevents healthcare professionals from performing medical and surgical procedures unless it is to treat an emergency medical condition. This directive is open ended, meaning there is no definitive end date.CRIO: What does this mean for your research site?
CRIO: What does this mean for your research site?
Dr. Stone: Research has come to a halt. We were actively working on 20 clinical trials, but now we are only able to see patients in person who cannot be seen via telehealth, which has also been mandated by the State.
CRIO: Are you able to switch to virtual visits for clinical trials?
Dr. Stone: Only one sponsor has allowed us to discuss conmeds and conduct PROs over the phone presently, but virtual visits will not work for what study visits require. All of our studies require physical exams and imaging. In fact, most of our studies require a radiologic primary endpoint that cannot be collected if patients cannot come in. When patients are eventually able to return to the clinic, most data points will be out of window. Everyone understands that our hands are tied and we will do what we can though using telehealth.
CRIO: How are your sponsors maintaining oversight for ongoing trials?
Dr. Stone: We have received requests for remote monitoring, but most either want documents to be faxed or uploaded to Box after patient info has been redacted. We already have in place a system through CRIO, though that is far less labor intensive at this point. Since we are on eSource, everything is already available to the clinical research associates online. They are able to use the existing system that they are accustomed to already.
CRIO: What do you wish regulatory authorities would do more of?
Dr. Stone: Pointed communication. We are all in this together. Many of us are scrambling to meet the needs of a very fluid situation. The processes in place a week ago no longer meet the needs of today. Today’s processes will likely not meet the needs of tomorrow.
Everyone in the research world has been adversely affected by one aspect or another of the COVID-19 response. Now is the time for us to pull together and find solutions that launch us into the next phase of clinical trial work shaping the future of what we all do.
– Marcus Stone, MD, Director of Clinical Research at the Spine Institute of Louisiana Foundation
CRIO: How do you think COVID will impact the future of clinical research?
Dr. Stone: There is going to be a trickle-down effect. Stalled enrollment and missed follow up visits will increase the time and cost of clinical trials. This will lead to a significant slowdown in new drug and device development. New treatments that could have come out in, say 2022, now might come out in 2023. Sponsors’ commercial business will be negatively impacted as well due to a sharp decline in healthcare utilization. Consequently, it is likely they will invest less in research and development in the near term. Undoubtedly, COVID-19 will have a significant long-term effect on health care in general. That said, in the clinical trial world we are used to adapting and will manage these trying times. I am certain we will come out on the other side of this stronger and better equipped.