The first issue of the Orange Paper, the first analytical review on market of clinical trials in Russia, has been officially presented. The strategic goals of Synergy Research Group, a Russia-based emerging CRO, are formation of a civilized market of clinical trials in Russia, raising the country’s research attractiveness for foreign sponsors and exoneration of clinical trials in Russian public opinion. The Orange Paper will be published in Russia both in electronic and hard-copy form. The English language version will be distributed abroad by subscription and on websites dedicated to clinical trials; the hard-copy edition is to be distributed at international exhibitions and conferences. The first issue presents the general overview of the Russian market of clinical trials at the beginning of 2007. 

Statking Consulting, a provider of data related services for clinical trials, has completed a year-long expansion project at its headquarters to accommodate larger, late-stage clinical trials. This additional 2,500 square feet of space will be largely dedicated to case report form storage and housing the company’s growing computer network. The space has been refurbished to include state of the art climate, disaster and security controls to safeguard the client’s data. “In order to better serve our valued clients, we need to be able to house larger, late stage (Phase III) clinical trials,” said Dennis W. King, Ph.D., President of Statking Consulting. “With our acquisition and the completion of the refurbishing of this space, we will be able to accommodate Phase III drug trials and pivotal PMA device studies.”

A recently published multicenter study “Sex Differences in Perceived Risks, Distrust, and Willingness to Participate in Clinical Trials–A Randomized Study of Cardiovascular Prevention Trials” concludes, “Evidence underscores the importance of sex in influencing clinical trial enrollment.” This multicenter, double-blind, randomized study evaluated sex and trial scenarios on willingness to participate (WTP) in cardiovascular prevention trials and examined sex differences in perceived risks and distrust. Hypothetical trial scenarios, randomized multifactorial vignettes of adverse effects, trial durations, sponsors, financial incentives, and conflicts of interest. According to the study, multiple sex differences exist in cardiovascular disease burden and treatment efficacies, and adequate participation of both sexes is crucial to clinical research. The paper is published in Archives of Internal Medicine, Vol. 167, No. 9, Pg. 905-912.

According to a new Weill Cornell Medical College research study, medical research scientists in public health and other areas routinely make ethical value judgments. And not only do these judgments not lead to bias necessarily, but they can make for better research. Published in the current issue of the European Journal of Epidemiology, the paper finds that the framing of the research question, identification of the problem, as well as the design and methodology of the study, are all subject to value judgments by investigators. To illustrate this point, the study focuses on how value judgments are made in epidemiological research of racial health disparities. “The paper makes a compelling argument for integrating ethical reasoning into studies in order to make explicit the value judgments that can distort analysis,” says Dr. Joseph J. Fins, chief of the division of medical ethics and professor of medicine and public health at Weill Cornell Medical College.

VisualMed Clinical Solutions announces that the VisualMed Electronic Health Record will be deployed in a subscriber user format over the Web for the internet community by a new joint venture partnership between its licensee Medical.MD of Montreal, Canada, and a group of associates that includes an International advertising agency and a leading provider of information technology. The agreement calls for the company to receive a one-time license fee of $1.5 million, in addition to a royalty stream equal to 15% of the overall revenues of Medical.MD. Subscribers will have a fully secure, immediate access to their full personal medical record from anywhere in the world, and will be able to independently manage their personal health record. Medical.MD is providing the same medical technology currently in use in paperless hospitals in the U.S. and Canada.