Cardiovascular disease is the number one cause of death in the world. However the number of drugs that entered the different phases of clinical trials has decreased in the last two decades.
The research study focused decline in the number of cardiovascular drugs entering different clinical phases in the last twenty years was published in the JACC: Basic to Translational Science.
‘The number of cardiovascular drugs that undergo clinical trials have declined in the last two decades.’
About 1 in 3 patients die due to cardiovascular disease in United States. This leads to a growing concern for the development of new drugs for treatment.
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 research team analyzed the data collected from drug development database. The study was carried out using the cardiovascular drugs that entered Phase 1 clinical trials from 1990 to 2012.
Around 347 drugs including antihypertensives, lipid lowering agents and anticoagulants entered phase 1 clinical trials which focus on human pharmacology and drug safety. In 1990 - 1995, around 16% of drugs were initiated for phase 1 clinical trials while only 5% of drugs entered clinical trials during 2005 - 2012. In the same way, Phase 3 trials which focus on the efficacy and effectiveness of the drug accounted for21% in 1990 whereas in 2012 it was only 7% .
Senior author of the study Aaron S. Kesselheim said, "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 "
Most of the cardiovascular drugs were found to target a new biological pathway and the number of new drugs that enter phase 3 trials rose from 27% in 1990 to 57% in 2012.
The editor-in-chief of JACC- Basic to Translational Science , Douglas L. Mann, M.D., FACC said that "These findings are not entirely glass-half empty, 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."
Mona Fiuzat, PharmD, FACC and colleagues from the FDA emphasized the need for new drug targets and drug strategies for phase 2 trials.
"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."