Published on April 9, 2020
We don’t’ know when the COVID-19 crisis will end, despite the optimist predictions of everything will be OK by Easter to the worst case predictions of up to 18 months, but we do know that when it ends healthcare will be reexamined from every perspective as to how it is administered, managed, and researched. During 9/11, I experienced a similar industry shock and re-examination when I worked in the IT/Telecom industry. I can recall the transition from near overwhelming reflection to rapid, intense changes in network architecture, security, adaptability, emergency services, city planning, and resiliency. Now I am having many thoughts and reflections on clinical research in a post-COVID-19 world.
Clinical research will most likely see far reaching changes with more attention given to remote communication, remote monitoring, e-consent, and other remote and electronic tools, which will need to be balanced with GCP, ethics, privacy, and the need for in-person interaction. Two key factors that could push this change will be the tragic loss of medically trained people due to terrible death rates of front-line healthcare heroes across the globe. This will result in a lack of medical care in general, which will have a knock-on effect on research and clinical research. In addition, there will be more safety concerns for healthcare workers and patients. The other factor will be the political, financial, and societal support for medical and clinical research going forward via acknowledgment that clinical research, especially in infectious diseases, virology, inflammation, vaccines, and anti-bacterial resistance will be more important than ever. Thus many of the long discussions on modernizing clinical research may finally come to fruition.
Clinical research will need to respond and adapt to this new reality. Some key opportunities will be new or optimized processes, methods, and adoption of technology for remote monitoring, decentralized monitoring, risk based monitoring, and patient activities to protect patients and medical staff, while making clinical trials more efficient and effective.
Communication, telemedicine and other remote tools are being utilized more than ever, via virtual consultations by physicians, which have been happening for years, for example a 2014 article in Becker’s HealthIT demonstrated the high rate of adoption of technology in healthcare that could easily be implemented to more clinical trials:
- Boston-based Partners Healthcare, treated more than 3,000 congestive heart failure patients with used at-home monitoring devices. Patients sent updates of their weight, blood pressure and other metrics to Partners. Clinical decision support software was used to identify the patients who needed interventions. The program ultimately reduced readmissions among the participating patient population by 44 percent while generating cost savings of more than $10 million.
- Veterans’ Health Administration ran a 4-year program that combined remote patient monitoring, health informatics and disease management technology to improve care for patients with six chronic conditions ranging from depression to diabetes. In addition to high patient satisfaction scores, the program achieved a 25 percent drop in bed-days of care and a 19 percent reduction in hospital admissions as compared to traditional care.
- Kaiser Permanente dermatologists in San Diego treated patients by reviewing images and patient information uploaded and sent to them over a secure server by referring physicians, rather than seeing every patient in person. The practice’s physicians now handle 800 cases per month, 50 percent more than solely face-to-face visits.
- Intensive care unit beds throughout the US are supported by tele-ICU technology. At the University of Massachusetts Memorial Medical Center in Worcester, trained intensivists provided ICU care remotely, which resulted in a 20 percent decrease in mortality, a 30 percent drop in lengths of stay and reductions in care costs.
More recently, actions by the US in response to Coronavirus, detailed in the Coronavirus Preparedness and Response Supplemental Appropriations Act, dramatically increased healthcare professional’s ability to engage more easily via telemedicine
- Centers for Medicare & Medicaid Services (CMS) provided more flexibility for use of telehealth and expanded access to telehealth services.
- The federal government waived rules that prevented telehealth services from being deployed across state lines, while some States are requiring telehealth services as part of emergency planning.
The point being is that many of these activities and action were not common in clinical research prior to COVID-19 and this is just one national example. Meanwhile, similar actions are taking place or have occurred across the Globe. There is no reason to think modernizations, like the above, would not become more common within in clinical research.
Although clinical trials are incorporating more remote services, procedures, standards, and practices through the adoption of technology, more remote activities could be implemented at higher rates. However, regulatory/GCP, sponsor, site acceptance and adoption, and patient safety and ethics review is needed. Not all indications will be able to be managed in this way, but these methods could be more widely applied. This will also reignite the discussion and reexamination of what level of data quality is sufficient for purpose.
Therefore, CROs, sites, and PIs, that can supplement extensive experience in clinical research with proven experience and implementation of remote tools and methods may have an advantage in the near future and/or during the possible resurgence of COVID-19 in the Fall of 2020 or the next pandemic. Some key criteria to consider when setting up clinical trials, beyond new regulations, will be:
- Effective use of e-communications in a clinical research setting
- Proven success in online recruitment, e-consent, e-screening methods, e.g. – well-established nurse-led voice/video/electronic pre-screening processes
- Experience in remote QA procedures, training, conducting and recruiting remote clinical studies
- Robust IT capacity, slim & scalable IT design/architecture, i.e. – EDC, IWRS, eTMF, Tele/Video conferences, FTP capacity with sites, patients, regulators, inspectors
- Incorporation of flexible platforms that accentuate interoperability, ease of use, quick implementation, such as Viedoc – www.viedoc.com
- Global electronic platforms for modernization of the delivery, distribution, and training and education on regulations, certifications, standards for GCP compliance such as Blue Cloud from HealthCarePoint – www.healthcarepoint.com
- Ability to remotely educate patients on self-examinations, swabs, blood prick tests, urine/feces, and ability to partner or logistical expertise
There are still more questions than answers and to date nothing can fully replace in-person patient/doctor interaction in a clinical setting. However, it is increasingly clear that clinical research will most likely not be performed as it is today in the post COVID-19 era.
Special thanks to Gunnar Danielsson and Dr. Austin Smith for their editorial review