In the past, data from clinical trials of new drugs and medical devices have been the property of the companies that designed them, and they were allowed to control how and what data was released.
Approximately 50% of patients do not take their medications as prescribed. This lack of adherence severely compromises patient outcomes and increases patient mortality and is estimated to incur costs of approximately $100 billion per year.
The National Institute for Health and Care Excellence (NICE), an organization given the responsibility of setting the standards for high quality healthcare in the UK, has come under fire for being too conservative and resource-intensive.
In clinical trials of targeted therapy agents, sometimes the target is such a crucial driver of the neoplastic process, that its inhibition is able to stop the growing tumor in its tracks.
At last month’s ASCO conference, rapt attention was given to a presentation on the clinical trial results for the drug Avastin for patients recently diagnosed with an aggressive form of brain cancer, glioblastoma multiforme (GBM), according to an article by Clinton Leaf appearing in the New York Times, which is summarized below, with our comments added.
The FDA recently added a new designation, ‘Breakthrough Therapy’, to its roster of pharmaceutical regulatory terminology in order to ensure that truly innovative compounds get to the patients who need them most as soon as possible.
Two of the biggest pharmaceutical companies, Pfizer Inc. and GlaxoSmithKline, are significantly reducing spending with doctors for events at which doctors make presentations to their peers.
