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.
Placebo-controlled clinical trials are the gold standard in drug development, in part to ensure that the efficacy of a new therapy exceeds the placebo response in the indication being studied. The placebo response is a measured improvement in clinical signs or symptoms that occurs in patients receiving a sham (or “dummy”) treatment. The placebo response is a
While significant placebo responses rates are often noted in clinical trials for indications like pain and depression, this issue can plague drug development in any therapeutic area – particularly in diseases that rely on subjective or patient-reported outcomes as primary efficacy endpoints. Quality of life (QoL) endpoints, for example, are often used to measure therapeutic efficacy in oncology clinical trials – but also in diseases like schizophrenia, pain, heart failure, inflammatory bowel disease (IBD), allergy and pruritus.
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).
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.
Osteoarthritis trials have relatively a rate of failure due to many factors, including disease heterogeneity, a disconnect between pain improvement and structural improvement, a strong placebo response, and high variability/inaccuracy in patient reporting of pain.