Saturday, June 28, 2008
Attempting to gain early efficacy data and examining possible biomarkers in intent-to-treat patients in phase I trials has become more commonplace as sponsors attempt to fill their thinning pipelines. And the use of advanced medical imaging and other diagnostics—especially in cardiovascular and central nervous system studies—has pushed the envelope of what traditional phase I units have handled. In many ways, complexity and an increased need for specialized expertise in early phase research is forcing many smaller phase I organizations to improve their infrastructure and focus on particular disease areas.
Four organizations involved in clinical research have joined together to create the Clinical Research Consortium of Massachusetts (CRCM), a cooperative enterprise that supports knowledge and technology transfer between Massachusetts and other international regions interested in building clinical research centers of excellence. The group’s first work is with the Lombardia region of Italy.
The Impact on Clinical Research of European Legislation (ICREL) project is funded by the European Commission’s Seventh Framework Programme (FP7) to measure and analyze the direct and indirect impact of the European Union Clinical Trial Directive 2001/20/EC and EU-related legislation on all categories of clinical research. The one-year ICREL project is being carried out by a consortium composed of the European Forum for Good Practice (EFGCP), European Clinical Research Infrastructure Network (ECRIN), European Organisation for Research and Treatment of Cancer (EORTC), Hospital Clinic I Provincial de Barcelona and the Ethics Committee of the University of Vienna.
The Association for the Accreditation of Human Research Protection Programs (AAHRPP) has accredited 22 additional organizations. In total, AAHRPP has accredited 129 organizations, representing more than 550 entities. AAHRPP’s standards exceed federal regulations. Accreditations are announced quarterly, and are valid for three years.
Bristol-Myers Squibb and AstraZeneca reported positive results from a phase III, pivotal trial of saxagliptin (Onglyza) for the treatment of type 2 diabetes. Saxagliptin could rival Merck’s newest diabetes drug, Januvia. The global diabetes treatment market is $23 billion, according to data from IMS Health.
Parexel, a top 10 global contract research organization (CRO), announced an agreement on June 13 to acquire UK clinical technology company ClinPhone at an 86% premium to its share price on the London Stock Exchange. The deal values ClinPhone’s shares at $182 million. Soon after the Parexel press release hit the wires, Quintiles, the market leading private CRO, said it is planning an all-cash bid for ClinPhone that would beat Parexel’s $182 million offer.