The FDA and National Institutes of Health (NIH) have provided guidance for researchers conducting clinical trials and human subject studies impacted by COVID-19, emphasizing safety of study participants. Suggestions include coordination with institutional review boards to limit study visits to those needed for participant safety or coincident with clinical care, conducting virtual study visits, and arranging for required laboratory tests or imaging needed for safety monitoring to occur at local laboratories or clinics. Certain self-administered investigational products typically picked up at the study site may be delivered through alternative secure methods. In addition to upholding the safety of research participants, it is important to safeguard the integrity of research efforts in schizophrenia, which despite its substantial global public health burden, has historically lagged in research funding compared with physical health conditions. Clinical trials in schizophrenia typically have smaller sample sizes than in physical disorders associated with comparable disability and costs, reducing their statistical power and the generalizability of their results. A prolonged cessation of new recruitment into ongoing research studies, coupled with the reduction or elimination of in-person research visits will exacerbate the challenges already present in schizophrenia research, including challenges in study retention. Ensuring the safety of both participants and research staff should be the foremost priority. However, research with participants with schizophrenia should continue through the use of remote assessments and delivery methods in order to prevent worsening disparities in the progress of schizophrenia research.
Schizophr Bull. 2020;46(4):752-757. © 2020 Oxford University Press