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Factor VIIa for ICH: Behind the Scenes of an Academic–Industry Collaborative Trial

Improved treatment for common, serious diseases such as stroke, which have huge implications for public health, is the most important goal of both academic investigators and the pharmaceutical industry. There have been two primary funding sources for clinical trials in the United States: the National Institutes of Health (NIH), and the pharmaceutical and device industries. The model of NIH funding includes a principal investigator or an investigative team who develops a research idea and writes a grant proposal that is submitted for rigorous peer-review. Successful applications are eventually funded to complete a trial. In this model, the steering committee of investigators, with NIH oversight, controls the data, which are monitored by an independent Data and Safety Monitoring Board (DSMB) that is also appointed by the NIH. Drugs and devices may be provided by industry, but control is clearly in the hands of the investigators. This NIH model of funding for clinical trials is responsible for the single greatest success story in stroke therapy to date: The National Institute of Neurological Disorders and Stroke rt-PA trial (1). Many other promising NIH-sponsored trials are also in the pipeline, including the Interventional Management of Stroke (IMS) trial, which is evaluating intravenous rt-PA as ‘bridging therapy’ to more definitive intra-arterial intervention, and the Albumin in Acute Ischemic Stroke (ALIAS) trial. However, the vast majority of phase III clinical trials for stroke over the past 30 years have been funded by the pharmaceutical industry. Pharmaceutical sponsorship of acute stroke trials, for instance, increased from 38% before 1970 to 68% in the 1990s, and this number is still on the rise (2, 3). Paradoxically, nearly all of the acute stroke trials sponsored by the industry have been negative to date. Industry-sponsored clinical trials