A few weeks ago I was on a panel with J. Rick Turner, Chairman of the Department of Clinical Research and Director of the Cardiac Education Center at the Campbell University School of Pharmacy. And, as usual, the most interesting part of the conversation happened after the panel was over.
As we were gathering our papers and checking our blackberries, Dr. Turner mentioned that he had written a new book on the issue of “integrated cardiac safety.” I asked him to send me an advance copy. And he did.
They don’t call him “Page” Turner for nothing.
His new book, “Integrated Cardiac Safety: Assessment Methodologies for Noncardiac Drugs in Discovery, Development, and Post Marketing Surveillance,” is a timely and important addition to the debate over drug safety and, equally important, safe use.
Consider the following brief excerpts:
“A drug’s development in the sense of improving its safety and/or effectiveness profiles does not stop at the point of marketing approval. Data collected during the drug’s use in large patient populations can lead to meaningful improvements in the drug. This term, lifecycle drug development, therefore emphasizes that it is vital to remain vigilant about the drug’s effects from the very beginning of the drug discovery phase throughout the entire time that the drug is on the market and hence available for prescription to patients, and it captures the spirit of this book very well.”
“So too does the term integrated cardiac safety. A central tenet of this book is that it is beneficial to discuss the assessment methodologies used to collect information on cardiac safety at four stages of lifecycle drug development—drug discovery and design, nonclinical development, preapproval clinical development, and postmarketing surveillance—in one book, and to integrate this information to the greatest degree possible.”
“Meta-analyses vary in the number of patients included since this is dependent on the numbers in the individual trials combined in the new analysis. However, typical numbers are also in the thousands. However, it is fair to say that statistical methodology is currently less well developed in the case of epidemiology studies than it is for randomized controlled trials: this is not meant as a pejorative statement, simply a statement of the current state of affairs that will hopefully and very likely change as additional spotlights on and developments in the field of pharmacoepidemiology increase.”
“It should also be noted here that the term nonexperimental is not a pejorative one compared with the term experimental. Piantadosi discussed two fundamental types of study design, experimental and nonexperimental. In experimental studies participants receive random treatment allocation, and observations are made under conditions in which the influence of interest is controlled by the research scientists. In nonexperimental studies the research scientist also collects observations but does not exert control over the influences of interest. Nonexperimental studies are often called ‘observational studies,’ but this term is inaccurate: it does not definitively distinguish between nonexperimental studies and experimental studies, in which observations are also made.”
The book, due out in November of this year is must reading – especially for Steve Nissen.
