Country-wide lockdowns as a countermeasure against COVID-19 have severely affected the clinical development of new agents. Pharmaceutical companies and academic institutions have chosen to de-prioritize and suspend certain clinical trials or to defer enrollment to a later date. In mid-cap to large-cap companies, a halt in trial enrollment has been decided on a case-by-case basis, but in small-cap companies, it can be across the board, due to their small number of ongoing clinical trials.
Academic institutions/hospitals may choose to halt all trial enrollment not only to minimize the risk of transmission for the trial participants but also to shift key medical personnel to treating COVID-19 instances. The pharmaceutical industry may choose to move resources away from other therapy areas and into new, high-priority clinical trials for anti-COVID-19 agents and vaccines. Thus, multiple therapy areas can be simultaneously affected at various degrees. Oncology is a therapeutic area that is particularly susceptible to disruption from COVID-19. Patients with cancer typically have increased risk of all infections, especially after treatment with toxic chemotherapy, stem cell transplants, or surgery.
While it is difficult to monitor the effect of the pandemic on clinical trials in real time, a new proprietary dataset of GlobalData, updated daily, allows investigation into disrupted trials across indications. Specifically, clinical trials that are delayed, suspended, or otherwise affected by the COVID-19 pandemic are aggregated daily and as of 8 April totaled 389 trials. A breakdown by therapy area shows that the greatest proportion of disrupted clinical trials concern clinical development in oncology (28%), followed by the central nervous system and gastrointestinal clinical development areas at 14% and 8%, respectively. Most instances of administration of injectable anti-cancer agents are performed in the inpatient setting. Trial investigators may hesitate to bring cancer trial participants as inpatients, due to the increased risk of exposure to COVID-19 within hospitals. Rather, they may choose to move these patients to an outpatient setting when possible, or delay treatment, thus disrupting the trial protocol. Within oncology, an indication breakdown shows that five tumor types are responsible for more than 50% of disrupted trials: lung cancer (15.6%), breast cancer (11.9%), multiple myeloma (8.3%), myelodysplastic syndrome (8.3%), and prostate cancer (8.3%).
Interestingly, 66% of all non-oncology, COVID-19-disrupted trials are sponsored by the industry, compared to 51% of oncology trials. The existence of large, cancer-focused academic institutions that serve as single clinical trial sites may contribute to this difference. Specifically, sites such as the Fred Hutchinson Cancer Research Center and the Centre Leon Berard are behind 10 and five disrupted oncology trials, respectively. Some of the affected companies in oncology are Boehringer Ingelheim International and BioNTech, with 12 and nine disrupted trials, respectively. Among the affected oncology pipeline agents are Aravive’s Aravive-S6, Immunomedics’ sacituzumab govitecan, and Jazz Pharmaceuticals’ Vyxeos, each with three affected trials. Whether the development of these products will be affected adversely in the long term remains to be seen.