We have absolutely no clue what clinical trials are out there for stroke, our fucking failures of stroke associations seem to have no clue and don't care. Why should they care? They aren't running the strategy or leadership. They stick to the easy crap; press releases on prevention and F.A.S.T. Almost impossible to get any more incompetent that that.
http://www.alphagalileo.org/ViewItem.aspx?ItemId=167285&CultureCode=en
The number of cardiovascular drugs in the research pipeline has
declined across all phases of development in the last 20 years even as
cardiovascular disease has become the number one cause of death
world-wide, according to research published today in JACC: Basic to
Translational Science.
While the development and use of new prescription drugs have been
associated with significant reduction in cardiovascular mortality over
the past two decades, cardiovascular disease is still the leading cause
of death in the developing world and accounts for 1 in 3 deaths in the
United States. There has been growing concern over the decline in the
development of new therapies.
Researchers analyzed data from a large commercial database of drug
development activity, which tracks the pipeline of pharmaceutical
research and development projects. The study included all products that
had entered Phase 1 clinical trials between January 1, 1990, and
December 31, 2012, and focused on drugs intended to treat cardiovascular
disorders.
During the trial period, 347 cardiovascular drugs entered Phase 1
testing, with the most common types being antihypertensive agents,
lipid-lowering agents and anticoagulants. The number of cardiovascular
drugs entering clinical trials in all stages of development declined
over time. Between 1990 and 1995, 108 of 679 (16 percent) of Phase 1
trials were initiated for cardiovascular drugs, compared to 125 of 2,366
(5 percent) of Phase 1 trials between 2005 and 2012. Cardiovascular
drugs accounted for 21 percent of Phase 3 trials in 1990 but only 7
percent in 2012. In comparison, the number of cancer drugs increased
over the same time period.
“These findings shed light on several important shifts in
cardiovascular research and development activity over the past two
decades. Importantly, while the overall number of new investigational
cardiovascular drugs has declined, we also found a relative growth in
the number of drugs targeting novel biological pathways ,” said Aaron S.
Kesselheim, M.D., J.D., M.P.H., associate professor of medicine at
Brigham and Women’s Hospital and Harvard Medical School and the senior
author of the study.
Half of cardiovascular drugs entering Phase 3 trials targeted a novel
biological pathway, or one for which the FDA had not yet approved a
therapeutic agent. The rate of novel drugs entering Phase 3 increased
from 27 percent in 1990-1991 to 57 percent in 2012.
While the development of most cardiovascular drugs was sponsored by
large pharmaceutical companies, the number sponsored by small and
medium-sized companies grew over time.
“These findings are not entirely glass-half empty,” said Douglas L.
Mann, M.D., FACC, editor-in-chief of JACC: Basic to Translational
Science. “Part of the decline in new drugs is that there are less ‘me
too’ drugs that are similar to those already available. The study also
refutes the premise that cardiovascular drugs are often riskier to
develop than drugs in other clinical categories.”
In an editorial comment accompanying the study, Mona Fiuzat, PharmD,
FACC and colleagues from the FDA emphasize the need for more
translational basic research to identify new drug targets and the need
to develop better strategies to identify successful drug candidates in
Phase 2.
“Because drug development follows science, continued investment in
the basic biology of cardiovascular disease is needed, and because large
populations are impacted, attention to improved efficiency of the
evidence generation system will be needed to generate needed sample
sizes for definitive trials at a lower cost,” they said. “Finally,
involving the full community including industry, the National Institutes
of Health, academic experts, funding agencies, regulators,
practitioners, and patients will be an important step in strengthening
the science and advancing the field.”
Full bibliographic informationTemporal Trends and Factors Associated With Cardiovascular Drug Development, 1990 to 2012
Thomas J. Hwang, AB, Julie C. Lauffenburger, PHARMD, PHD, Jessica M. Franklin, PHD, Aaron S. Kesselheim, MD, JD, MPH
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