Research Series: Article 6
June 11, 2020
Clinical Research Amid a Pandemic and A Path Forward
By Raphael Yaakov and Brian McManus
The COVID-19 pandemic continues to add to the death toll, with the US now exceeding 100,000, surpassing the number of Americans killed in the Korean and Vietnam wars combined and is approaching the US casualties for World War I.1 Thousands of new cases are still being identified each day; California, Virginia, North Carolina, Wisconsin, Alabama are among several states that have seen a rise in new cases in the last 14 days.2 The highest number of cases are among people 18-44 years of age, followed by those between 45-64 and seniors 75 and older.2 For people with chronic diseases, the COVID-19 pandemic continues to pose great risk. This is especially a great concern for patients participating in clinical research.
The pandemic has brought a large number of clinical trials to a halt, creating unprecedented clinical and ethical challenges. Wound care has not been immune from the impact of COVID-19. Hospital outpatient-based wound care departments were categorized as non-essential. Institutional research policies and sponsor guidelines have varied across wound care studies. Some research sites remained open and followed patients through treatment, implementing COVID-19 screening and testing; a few saw patients on a case by case basis, and other sites shut down completely. Site closures and interruption in care have resulted in major deviations from clinical protocol, including nonadherence to investigational product (IP), missed laboratory testing and lack of safety assessments. In some places, there has been an unsettling relaxation on standards and trial integrity.3
Clinical trials are the mainstay for advanced treatment options for patients who are chronically ill. Clinical trial patients often present with complex etiologies, have had little or no success with standard of care, and are usually underinsured; some may even have waited a long time to qualify for the study. The abrupt clinical hold left many patients without care. For wound care patients, in particular, this situation has been pernicious. Management of chronic wounds, including diabetic foot ulcers, venous ulcers, arterial ulcers, and pressure ulcers, require routine monitoring and care as these patients are prone to infection and sepsis. With no access to care, patients with chronic wounds are at risk for developing complications that can land them into the emergency room and further their risk of COVID-19.
The Alliance of Wound Care Stakeholders took a strong position, urging to keep clinics open for fragile cohort of patients with complex wounds at high risk of COVID-19.4 FDA has also provided guidance and clarity around conduct of clinical trials.5 The principal investigator, however, is ultimately responsible for assessing the risk and benefit, balancing patients’ rights and protection, weighing ethical and protocol obligations, and determining the appropriate course of action. Additionally, screening and risk assessments need to be considered for research staff to minimize risk of COVID-19. While the current circumstances demand greater flexibility, it does not lessen the ethical and moral obligations.
Amid this crisis, there is an opportunity to rethink how research studies should be conducted. Rapid advances in technology, coupled with proliferation and adoption of telehealth modalities, sensors, wearable and connected devices have paved the way for decentralized clinical trials (DCT). Change has come at a rapid pace in wound care. Telehealth services are promised to improve continuity of care and close the care gap. Especially noteworthy is the capability to monitor and capture wound assessments remotely. eKare (Fairfax, VA) is one of the leading wound imaging and analytics companies that has been at the forefront of innovation. At the height of the pandemic when providers, research sites and study managers were left without answers, eKare responded quickly, offering live teleconsultation with their advanced imaging technology for precise and reliable documentation.
Wound care as a fledgling specialty has come a long way and technology is set to reshape the delivery of care yet again. DCT or direct to patient studies represent a paradigm shift, enabling remote dispensing of IP, clinical assessments, wound measurement and data collection. It minimizes recruitment and retention barriers without comprising study design, quality or data integrity. The challenge centers around building the infrastructure to operationalize DCTs. Pragmatic, hybrid and fully DCTs have garnered support from regulatory agencies and with the movement of tech companies in the clinical research space, this new model is promised to disrupt clinical research.
Raphael Yaakov’s experience spans across phase I-IV drug and device multinational trials. He currently serves as Vice President of Clinical Operations at eKare.
Brian McManus has worked in clinical research for nearly 20 years, working with sponsors at a Clinical Research Organization on dozens of trials with a focus on collecting high quality endpoint data. As the former manager of a wound imaging core lab, he is well versed in the nuances of running wound healing trials. Working as the Director of Clinical Operations for eKare, Inc., he is invested in helping research clients collect wound healing data optimally.
The views and opinions expressed here are those of the author and do not necessarily reflect the official policy or position of any other agency, organization, employer or company.
1Department of Veterans Affairs. America’s War. Nov 2019 https://www.va.gov/opa/publications/factsheets/fs_americas_wars.pdf
2 Centers for Disease Control and Prevention. National Center for Immunization and Respiratory Diseases (NCIRD), Division of Viral Diseases. Coronavirus disease 2019. May 30, 2020. https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/cases-in-us.html.
3 Borfitz, D. Research Ethics Knocked Sideways by the Pandemic Clinical Research News. 28 May 2020. https://www.clinicalresearchnewsonline.com/news/2020/05/28/research-ethics-knocked-sideways-by-the-pandemic
4Alliance of Wound Care Stakeholders. Alliance Position Statement: Avoid Unintended Consequences for Wound Patients Amid COVID-19 Pandemic Response. March 20, 2020. https://www.woundcarestakeholders.org/advocacy/submitted-comments/alliance-position-statement-covid-19-unintended-consequences.
5FDA. Clinical Trial Conduct During COVID-19 Pandemic. June 1, 2020. https://www.fda.gov/drugs/coronavirus-covid-19-drugs/clinical-trial-conduct-during-covid-19-pandemic