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As the COVID-19 pandemic halted many in-person clinical trial visits, sponsors were faced with difficult decisions about whether to delay, cancel, or modify their on-going clinical trials. One option for some trials was to replace in-person visits with remote or...

As the COVID-19 pandemic made in-person visits difficult or impossible, sponsors and CROs turned to remote visits and remote assessments to keep trials running. This is an approach to which several regulators have signaled interest and VeraSci has endorsed. After...

The Expanded Disability Status Scale (EDSS) is one of the most widely used endpoints in multiple sclerosis (MS) research and in clinical trials of investigational treatments for MS. The EDSS is an elaborate scoring system applied to a neurological examination that...

We recently wrote about the first two special meetings of the Innovative Technologies Working Group of the International Society for CNS Clinical Trials and Methodology (ISCTM) to discuss challenges related to implementing remote assessments in CNS clinical trials in the context of COVID-19 precautions. These calls provided an open forum for discussion between FDA, industry, academia, and clinical trial sites. There has since been a third call, which also included participants from EMA sharing their views.

Preliminary Feasibility and Validity Data in Older Adults with and without Subjective Cognitive DeclineThis blog series shares what’s happening day-to-day in our Innovation Lab. The VeraSci Innovation Lab was created to pair scientific knowledge with cutting-edge...

Placebo response is a potentially devastating component of CNS trials, particularly those with subjective patient-reported outcomes and high levels of interaction with clinical staff. In pain, depression, and other psychiatric studies using subjective primary...

As more sponsors utilize electronic clinical outcome measures (eCOA) in their international clinical trials, these tools will also need to be accurately translated and culturally adapted for use in numerous languages and countries. eCOA translations must ensure that...

This blog series shares what’s happening day-to-day in our Innovation Lab long before we share the results in publications or at conferences. The VeraSci Innovation Lab was created to pair scientific knowledge with cutting-edge technology to improve the tools and...

With many study subjects isolating themselves at home and many sites concerned about seeing subjects in-person for routine study visits, we are seeing an increased interest in remote visits. Sponsors that consider this for their studies often choose to complete the remote visits with video conferencing tools in order to allow more interaction between sites and subjects. Even for those with experience using video in clinical trials, using it in a home-based setting brings unique challenges.

Many rare diseases lack the well-characterized endpoints that we associate with outcome measures in more common diseases and disorders. Given that most clinical trials for rare diseases are small and often rely on assessments that are not designed specifically for the disease, it is important that every assessment is administered and scored correctly. In trials conducted in very small populations, missing, erroneous, or invalid data can have an outsized impact.