Dec10 Machine Learning Meets Clinical Pharmacology
Generating “big data” has become increasingly easier and less expensive over the last decade, and the need for computational methods for the analysis of these data are fueling the burgeoning field of data sciences. The challenge for clinical pharmacology will be to rapidly assess and apply new comp... Read More..
Nov28 Design, Conduct, and Publication for First‐in‐Human Trials
Houck et al ., recently published a paper in Clinical and Translational Science (CTS) on the first-in-human (FIH) trial for NYX‐2925, a novel N‐methyl‐D‐aspartate receptor modulator . This was a single ‐ center, phase I, randomized, double ‐ blind, placebo ‐ controlled study conducted i... Read More..
Nov16 Here in My CAR(T)
In a recent Commentary published in Clinical and Translational Science , Rodriguez-Cartagena and co-authors provide an excellent introductory overview of the emerging field of Chimeric Antigen Receptor (CAR) T-Cell therapeutics . The Commentary provides a comprehensive summary of the scie... Read More..
Oct09 Guiding Science with Tutorials: First-in-Human How To
Few topics have received greater interest in the world of early clinical development over the past year than the updated EMA Guidelines on First-in-Human and Early Clinical Trials , finalized in July 2017. Following release of the revised guidelines, the pharmaceutical industry has taken a close... Read More..
Sep26 Exposure-Response for Safety? I’ll Believe It When I See It
As our modeling colleagues in drug development remind us, exposure-response (ER) analyses are a critical component to proper dose selection, with the transition from phase II to phase III as a particularly critical juncture. Beyond maximizing efficacy, ER can be incredibly valuable for the interpre... Read More..
Sep10 Imaging the 510(k) Diagnostic Approval Process
Biomarkers and diagnostics are a key focus of Clinical and Translational Sciences (CTS) . Biomarkers are the “glue” and common language of translational medicine, and are enjoying a renaissance of increased cross-stakeholder interest. The surge of work in the field of biomarkers include acti... Read More..
Aug22 Safety Signal or Chance Finding in First-in-Human? There’s a Model for That!
A recurring challenge in early drug development is the interpretation of emerging safety data from first-in-human (FIH) studies, where typical dose escalation for a novel small molecule follows a 6+2 paradigm, whereby 8 subjects (6 active, 2 placebo) are dosed in each ascending dose cohort. Eme... Read More..
Aug09 The Very Variable Metabolism of the Big T
The effects of testosterone, the big T, and a testis-derived substance driving male characteristics have been known since antiquity, as farmers knew the effects of castration on decreasing aggression and increasing body weight. Not surprisingly, the path to the discovery of testosterone and solving... Read More..
Jul18 CTS Impact Factor More Than Doubles to 1.954!
The most recent impact factor (IF) numbers are in, and Clinical and Translational Science (CTS) is clocking in at 1.954, a more than 2-fold increase over the previous year. Simply stated, the IF is a way of assessing journal performance by calculating how often researchers cite journal p... Read More..
Jul03 Plug and Play for Clinical Data Sharing
Have you traveled internationally recently? If you have, I’m sure you’ve had to lug around an electrical adaptor or two to recharge your devices. Why? Because the world does not have one standard for electrical plugs. Can you imagine how convenient it would be if there was one worldwide standard? N... Read More..