GlaxoSmithKline took a bullet from the anti-industry New England Journal of Medicine, which did a meta-analysis of data about the GSK diabetes drug Avandia. The Cleveland Clinic’s Steve Nissen calculates Avandia to raise the odds of cardiovascular-related death by 64 percent and heart attack by 43 percent; GSK disputes those figures, citing a variety of large trials that showed Avandia’s cardiovascular risk profile to be no better or worse than competitive products. News coverage is already focusing on the inadequacy of both existing and proposed legislation—and on the basic competence of the FDA. The data used by the NEJM were disclosed as part of a settlement with state officials in New York. Nissen contends ongoing post-marketing trials designed by GSK were too small to detect the safety signals he discovered. Glaxo’s exposure to litigation is unclear at this point. London traders had sent the company’s shares down 8 percent at press time. Congress is scheduling testimony on the approval of Avandia.

The Clinical Data Interchange Standards Consortium (CDISC) has agreed to lead a project to address one of the Food and Drug Administration’s (FDA) Critical Path Initiative Opportunities: Consensus on Standards for Case Report Forms (CRFs). “A wide array of different forms and formats are used to collect clinical trial information, and most data are submitted to the FDA on paper. Differences in case report forms across sponsors and trials create opportunities for confusion and error,” the organization notes. The CDISC Clinical Data Acquisition Standards Harmonization (CDASH) project is designed to address this problem. “From the FDA’s perspective, the quality and integrity of the data is paramount. Common standards for case report forms can improve both, and are also a crucial enabler for the biomedical research of the future, for example, to support genotypic and phenotypic evaluation of each subject. We appreciate CDISC taking the leadership role to start now to create the data collections tools for the future,” says Janet Woodcock, deputy commissioner and chief medical officer at FDA.

The founder and CEO of etrials, John Cline, has abruptly resigned. Cline was an early and passionate advocate of electronic solutions in clinical trials. Eugene “Chip” Jennings was named the company’s new president and chief executive officer. An MBA, Jennings has experience at Baxter, among other places. “Chip is the right person to lead etrials as it continues to transform into a major player in the industry,” said Cline, who will remain on the company’s board. “I am extremely proud and honored to have led our great employees from a small North Carolina start-up software firm to a top-tier, publicly-held global eclinical solutions company. As I move on to other entrepreneurial endeavors, I remain committed to etrials and support this change in management as a step forward in building a leading eclinical software solutions company.”

Spheris and other leading clinical documentation providers have joined an industry-wide effort to establish clear standards and specifications for clinical documentation. The project, called Clinical Documentation Architecture for Common Document Types (CDA4CDT), is designed to create universal guidelines and templates for the most common types of dictated clinical documentation. Establishing industry standards will help ensure the interoperability of Health Information Management (HIM) systems and the effective exchange of data between health care providers. As described in a recent press release from CDA4CDT, the project was initiated by the American Health Data Institute (AHDI), American Health Information Management Association (AHIMA) and M*Modal, and is being managed by Alschuler Associates. Spheris has signed on as a benefactor and key contributor to CDA4CDT.

Pharm-Olam International (POI), a full service CRO to pharmaceutical and biotech industries, will host complimentary seminars on conducting clinical trials in India and Romania. The seminar will focus on recent changes of interest in these two nations and will be held in La Jolla on May 29, San Francisco on May 31, and Cambridge, MA, on June 6. Dr. Radhika Bobba from Bangalore, India, will present information concerning the potential of India for drug development including how India differs from other world markets, how to take advantage of recent changes in regulatory approval, enforced patent protection and the growing market for research across a variety of therapeutic areas. Dr. Ramona Nicolescu from Bucharest, Romania, will discuss how Romania’s transition into the European Union impacts clinical trials, the population’s therapeutic needs, medical infrastructure and the regulatory process of Romania. For further information about the complimentary seminars, visit POI site.

SecondStory Health, has announced details of a scientific audio conference entitled “Building Safety into Human Research Protection Programs”. The live audio conference is scheduled for May 30, 2007, from 2–3 p.m. EDT. IRBs, investigators and sponsors are responsible for minimizing risk to research subjects. This briefing will examine the current state of subject safety in clinical research and develop the premise that there is a gap between safety practices in clinical research and standards emerging from the broader national patient safety movement. Evidence for this gap can be found in publications, accreditation standards, regulations that govern human research and the organizational relationships and infrastructure that define how research is conducted. The speakers will introduce the concept of latent systems error in clinical research using medication safety as the teaching point for discussion. In contrast to post hoc review of adverse events by a data safety monitoring board, the new construct designs safety into the research plan and the policies and procedures of IRB’s, sponsors, CRO’s and healthcare organizations that conduct research. For online registration, click here.

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