To prioritize the safety of trial participants and site staff, many sponsors have either paused studies or halted new patient enrollment for ongoing studies, significantly reducing clinical trial activities. There is currently a large backlog of studies that will eventually need to be restarted and many are wondering what the clinical research industry will look like post-COVID.
Clinical Research IO spoke with several industry experts to gain insight on enrollment once clinical research ramps up again.
Matt Clair, President of Precision Recruitment, a recruitment company that works with research sites across the United States, explained
When the economy is rough, we usually see a boom in the number of people that get involved in clinical research. In addition to providing much needed healthcare, participation in a study may serve as an additional avenue of income for patients.
– Matt Clair, President of Precision Recruitment
Coronavirus has not only affected the landscape of healthcare, but has negatively impacted the global economy. In the last three weeks alone, 16 million individuals have applied for unemployment insurance, and many experts are predicting that the unemployment rate is in the 15-20% range or even more. With a loss of employment, people will have difficulty maintaining insurance coverage, receiving appropriate physician care, and covering bills.
While a dip in the economy is usually followed by an increase in study participation, the shelter in place requirements for COVID may delay the spike in new patient enrollment. Nevertheless, Clair predicts that this spike will occur after the stay at home requirements are relaxed.
Karen Kolin, the Site Director of Oviedo Medical Research, echoed this prediction.
After COVID related quarantines are lifted, people will need fast access to healthcare and medications, and clinical research can be a hero to these patients.
– Karen Kolin, Site Director of Oviedo Medical Research
Clair also reports that the contact rate with patients has significantly increased. Clair advised that, “Reaching people on the phone is usually the toughest part of study recruitment, but due to stay at home orders, we have been able to reach a wider audience and inform them about upcoming research. They also stay on the phone longer, and are happy to refer friends and family who they might know have been furloughed or laid off.”
Tyler Hastings, Managing Partner of DelRicht Research, also noted the increase in patient contact but was hesitant to say that there will be a spike in patient enrollment post-COVID. Hastings cautioned that, “While patients may express interest in a study, they may not follow through if a significant amount of time elapses between when a patient is first contacted and when they can be scheduled for screening.”
Experts offered the following advice to sites to prepare for study reinitiation and the potential spike in patient enrollment:
- Prioritize patient engagement. Stay in touch with your patients and let them know about the studies that are still on the table and about the ones that will be coming up.
- Consider altering the way your recruitment team is approaching patients. In addition to discussing study opportunities, really emphasize the steps that your site is taking to ensure patient safety (e.g. cleaning, protective gear, COVID screening measures) so that they know safety is a priority.
- Take advantage of the unprecedented high contact rate to pre-screen patients or establish new contacts. Existing patients may have family members or friends that may be interested in participating. Create waiting lists of patients that have been pre-screened.