Pharmaceutical Industry Alliance to Streamline Clinical Research

It was announced on September 19, 2012, that 10 major pharmaceutical companies will support the creation of a new, nonprofit organization called TransCelerate. This new organization’s mission is to accelerate the development of new drugs. The initial goals are to improve the efficiency of clinical trials. Clinical trials, particularly phase III trials, are the most costly in terms of time, effort, and finances of any component of drug development.

TransCelerate will focus on improving clinical trial efficiency in five areas:

• Development of a shared user interface for investigator site portals;
• Mutual recognition of study site qualification and training;
• Development of risk-based site monitoring approach and standards;
• Development of clinical data standards, and;
• Establishment of a comparator drug supply model.

Leading this effort will be Garry Neil, former corporate vice president at Johnson & Johnson. At this time, there is limited information available on how the organization will be structured, but it will receive resources and funding from the 10 original supporting companies: Abbott, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, GlaxoSmithKline, Johnson & Johnson, Pfizer, Roche’s Genentech division, and Sanofi. It is assumed that TransCelerate will draw from the experience (and time) of employees at each of these companies. As stated by Amy Ritter in PharmTalk (2012), “In years past, drug development was a secretive process. However, the rising cost and diminished success rate of bringing new drugs to market has forced the realization that going it alone is not always the most effective or efficient way of developing drugs. This realization has resulted in greater willingness of pharmaceutical companies to collaborate—with academics, with government agencies, and now, with each other.”

It is expected other organizations that are involved in similar efforts -- Clinical Data Interchange Standards Consortium (CDISC), Critical Path Institute, Clinical Trials Transformation Initiative, Innovative Medicines Initiative, contract research organizations; and regulatory bodies including the Food and Drug Administration and European Medicines Agency (EMA )-- will be recruited and their previous efforts incorporated. However, at this time their role in this industry initiative was not defined.

KAI has long been involved in the creation of neurological data standards for various therapeutic areas. This work has been sponsored by both the National Institutes of Neurological Diseases and Stroke and the National Institute of Child Health and Human Development. Additionally, KAI has assisted the public-private partnership, Analgesic Clinical Trial Innovations, Opportunities, and Networks and CDISC to develop data standards for pain research. KAI has also been actively introducing efficiencies into study monitoring processes by developing strategies and guidelines for Risk Based Monitoring

(http://www.kairesearch.com/whitePaper/WhitePaperFinal020712.pdf).