The FDA released its final guidance regarding the use of covariates to improve the precision of statistical analyses in clinical trials on 26 May 2023. It is a major step forward in the statistical analysis of clinical trial data. Recognizing that nearly a decade ago, the publication of the EMA guide initiated the movement, the FDA has crystallized the concept with the current guidance.
Many sponsors err on the side of reluctance when incorporating new technology in clinical trials. This is because some technologies have the potential to overly burden not only study operations but also (and most importantly) patients. In this blog, we walk through Cognivia’s approach – and how we make implementing new tech an easy choice.
Placebo response is one of the biggest threats to clinical data analysis– especially when left unchecked. In this blog, we review the top three risks trial scientists must address (and how to address them).
Each September, pain advocates and specialists raise awareness about issues facing the millions of people living with chronic pain. One of the most pressing? The lack of treatments available to alleviate suffering. In this blog, we look at three top challenges of getting new pain drugs to market—and offer a potential solution.
Tools4Patient presented data at the MDS Congress 2021 that predicted the placebo response in Parkinson’s disease (PD) in a multi-center, multi-national clinical study.
In May 2018, Tools4Patient (T4P) presented a webinar entitled “Characterization of Individual Patient Placebo Response: Impact on the Clinical Study Power”.