Creation and implementation of a historical controls database from randomized clinical trials

Abstract

It is technically feasible to pool portions of placebo populations through a stratification and segmentation approach for a historical placebo group database. A sufficiently large placebo controls database would enable previous distribution calculations on representative populations to supplement, not eliminate, the placebo arm of future clinical trials. Creation of an industry-wide placebo controls database, utilizing a universal standard, beyond the borders of Pfizer would add significant efficiencies to the clinical trial and drug development process.

Neuro-Bio-Behavioral Mechanisms of Placebo and Nocebo Responses: Implications for Clinical Trials and Clinical Practice

“…A number of approaches have been published (Cockayne et al, 2014). Finally, initial attempts have been made to avoid involving patients that receive placebo and instead use historic placebo controls from large trial databases (Desai et al, 2013).…”

Refining gold from existing data

“…The most straightforward and successful was the ePlacebo project at Pfizer [26]. They used placebo control groups from 203 of their studies to obtain a well characterized set of about 20,000 patients that could be reused as controls in future studies.…”

Developing a synthetic control group using electronic health records: Application to a single-arm lifestyle intervention study

“…Several studies have utilized historical controls to assess treatment effects to reduce bias from pre-post comparisons, decrease patient burden, and to save costs ( Desai et al, 2013 , Gökbuget et al, 2016 , Mendell et al, 2016 , Viele, 2014 , Peddada et al, 2007 ). When it is not feasible to identify appropriate controls from previous trials, the electronic health record (EHR) infrastructure offers a tremendous resource.…”