Clinical research during COVID-19-challenges and solutions

ABSTRACT

Background: Integrative therapies such as TCM are often expected to establish their usefulness through evidence based methods that are acceptable to all stakeholders. Objective: To describe the challenges of recruiting and retaining participants in a clinical trial during COVID-19 Study Design: Commentary and observations during a prospective case series investigating the usefulness of a Chinese herbal medicine for osteoporosis. Challenges Our clinical trial intended to recruit a small number of patients (n = 10). But the follow up was for one year and also required DEXA scans periodically to assess the improvement in bone density. The pandemic's impact was felt on the recruitment, data collection and compliance of study protocol. It also created challenges in retaining all patients in the trial, who were recruited already.When the pandemic hit us, we were in the middle of the trial. Several patients needed the herbal supplement refill, some required scans, and others required clinical screening and evaluation. With the closures, we had to move the data collection points. The diagnostic imaging center did not prioritize the scans for clinical research patients over other essential patients creating missing data. Patients in the trial, who had questions regarding the supplements or time points felt disconnected as well. Mailing of supplements were not easy because of the pandemic and the fear of virus on the mailed packets. Solutions A dedicated research assistant, who maintained a personal relationship with the research patients kept the communication channel open and could explain the next steps and how the trial is being conducted in the new challenging situation. Patient cooperation was requested in distributing the supplements in the parking lots, DEXA scans were skipped for one time point. Study forms were emailed. Conclusion: Despite these challenges, only one patient dropped out of the study and could successfully recruited all patients.