Revision several months after the pandemia: The collateral effects in a clinical trials unit

ABSTRACT

Introduction: The pandemic has affected various levels of health assistance and we have to wait to know all the aspects that COVID-19 has entailed. Surgeries, rehabilitation, teaching programs, inclusion in clinical trials, pharmacokinetics (PKs), and expanded coagulation studies were suspended. Since next working day after lockdown we organized assistance through teleconferences with the staff working onsite, Clinical Research Associates (CRA) and sponsors, Patient's Association and with people with hemophilia and their caregivers. Also, we had to deal with the stop in 3 trials affecting 5 patients. Our Clinical Trials Unit (CTU) has 2 study nurses, 1 study coordinator, 4 hematologist investigators and 4 researchers, having 59 clinical trials and observational studies open, with more than 200 patients. Our aim is to identify the non-priority procedures affected Methods: We evaluated the assistance provided by the CTU of Hospital Universitario La Paz, from February to September. Assistance was categorized as priority procedures (administration of treatment, urgencies, telephonic follow-up visits and home deliveries of treatment) and non-priority procedures (PKs, onsite follow-up visits, screening/baselines, monitoring visits by CRAs and health education using apps/devices) Results: Since March 16th only 3 of 11 members of the CTU were onsite, 2 of them attending patients with COVID-19 outside our Unit. We performed 17 priority procedures and 0 non-priority. In April, we started going one day/week alternating between staff members. We performed 9 priority procedures and 0 non-priority procedures. In May, we started going twice/week, alternating staff members and performing 26 priority procedures (13 with home delivered treatment) and 4 non-priority procedures. In June, all the staff began to work onsite performing 14 priority procedures and 10 non-priority procedures. During holiday with less staff onsite, we performed 5 priority procedures and 29 non-priority procedures. In September, all staff were working onsite and we performed 3 priority procedures and 38 non-priority Discussion/Conclusion: Only in 2 of the 6 months of observation the whole staff from the CTU was onsite. This stopped and delayed non-priority procedures very important for diagnosis and management. We spent 3 months without performing a single PK, screening or baseline. We also have to consider that delays in clinical trials will affect the availability of products on the market.