Category: Analyses

FDA Sentinel Initiative

Sentinel is the FDA’s national electronic system which has transformed the way researchers monitor the safety of FDA-regulated medical products, including drugs, vaccines, biologics, and medical devices. Sentinel has developed the largest multisite distributed database in the world dedicated to medical product safety. In September 2019, FDA announced Sentinel would expand to three distinct coordinating […]

Observational Study Results Aren’t Much Different Than Randomized Controlled Trials

For many years it has been claimed that observational studies find stronger treatment effects than randomized, controlled trials. A meta analysis compared the results of observational studies with those of randomized, controlled trials. That analysis found little evidence that estimates of treatment effects in observational studies reported after 1984 are either consistently larger than or […]

Neuro-Inflammation Case Study

These analyses suggest that this individual’s depression may be a manifestation of cytokine-induced interference with the conversion of tryptophan to melatonin and serotonin in conjunction with increased glutamate receptor activation. Background Recent studies have focused on the role of immune dysfunction in depression. and analogies to “cytokine-induced sickness behavior”. Sickness Behavior – Behaviors that develop […]

Human Costs of the High Cost of Clinical Research

Since 1962, the cost of bringing a new treatment to market has gone from $74 million to over $1 billion US dollars (2020 inflation-adjusted). Treatments for Rare Diseases Make No Financial Sense The costs of FDA regulations do not vary with the number of potential users of the drug, so the decline in drug development […]