The COVID-19 pandemic and associated social distancing measures are creating unprecedented challenges for everyone working in clinical trials and drug development. In this series, we’re sharing some of the ways VeraSci is addressing these challenges.
With many subjects isolating themselves at home and many sites concerned about seeing subjects in-person for routine study visits, we’re seeing an increased interest in remote assessments. For some on-going trials, conducting remote assessments may be a better choice than not collecting any data because of missed visits. In other cases, sponsors had planned to start studies soon and are now considering site-less or virtual trials as a way to keep their development programs on track.
Many CNS clinical trials include motor assessments as either an outcome measure, like in many Parkinson’s disease trials, or to detect motor side effects like tardive dyskinesia. One newly developed and exciting scale for remote motor assessment is the Remote Movement Disorder and Assessment Scale (RMDAS). Unlike many other options, the RMDAS was developed specifically for remote assessment.
The RMDAS allows the rater to complete two standard scales—the Abnormal Involuntary Movement Scale (AIMS) and the Barnes Akathisia Rating Scale (BARS)—along with a new scale, the Remote Extra Pyramidal Assessment Scale (REPAS), that replaces the traditional Simpson Angus Scale (SAS). The RMDAS is administered by videoconference and includes instructions to help the subject position the camera (any device with a camera will do), set-up the room (a chair without arms a measured distance from the camera), and app.
The RMDAS removes the need for the patient to visit a clinic while still allowing raters to assess:
- Extrapyramidal signs and symptoms (slowness, rigidity and, tremors)
- Tardive dyskinesia
As always, there are no one-size-fits-all answers when it comes to choosing the right scales, outcome assessments, or endpoints. For each trial, you must consider the indication being studied, characteristics of the investigational product being assessed, the patient population being studied, and more.
Additionally, while recent guidance from the EMA and FDA reflects a willingness by regulatory authorities to be flexible, it won’t be the Wild West. VeraSci has extensive expertise and experience working with the RMDAS as well as other motor assessments. Whether you are planning a trial starting soon or trying to decide what to do with an on-going study, we can provide insight into the best options for your trial.