The cardio factor: An insight into heart disease

The blood pumping mechanism of the body, ie the heart, is one of the most important organs in the human body. This is one of the organs which experiences extensive stress. The stress which the human heart goes through is because of both internal and external factors. Some of the factors could be genetic in nature because of which there could be abnormalities in the heart at birth. Sometimes changes and abnormalities develop at later stages in life which may have gone undetected earlier.
 
Needless to say, in most of the problems related to the heart, particularly in the ages of 35 and above, the external environment plays a major role. Stress and untimely eating habits are the two major causes of the rise of heart problems starting with hypertension. In the elderly population heart diseases are prevalent on a primary basis or associated as primary or secondary factors with other diseases like diabetes or the with the disorders of the central nervous system in general. The simplest and most common forms of heart disease is hypertension which is prevalent to the maximum in the working and urban population worldwide.
 
Research in heart disease is done via the form of clinical trials and data from the site https://clinicaltrials.gov/ shows more than 300 indications under the category of heart disease and related disorders. The top 10 indications account for greater than one lakh registered trials in all phases till April 2015. The top 10 indications for heart disease clinical trials are vascular diseases, heart diseases, hypertension, coronary artery disease, myocardial ischemia, arterial occlusive diseases, arteriosclerosis, atherosclerosis, coronary disease and hemostatic disorders.
 
  The top 10 indications account for greater than 60,000 registered trials and accounts for nearly 57 percent of the total registered clinical trials. Vascular disease trials alone account for 15 percent of the total registered trails in the cardiovascular category. About 10 percent trials fall under the heart diseases category of registered trials. A brief snapshot of the spread of clinical trials in the top 10 indications is depicted in the Graph.
 
A further analysis of registered cardiovascular clinical trial shows that 50 percent of the trials do not carry a listing of the phase of the clinical trial and the same inference is evident when the sources of funding are analysed. Majority of the trials which are listed in the cardiovascular category are industry funded in almost all phases of clinical research.
 
Exclusive phase 2, 3 and 4 taken together for heart disease clinical trials account for 40 percent of the registered clinical trials at https://clinicaltrials.gov/ in terms of sponsors. The largest contributor to the total of 40 percent is phase 4 trials followed by phase 3 and phase 2. Less than 5 percent of the total registered clinical trials for heart disease are present in phase 1 of clinical research. Phase 0 has less than 1 percent contribution in this category which indicates that not many identified drug compounds in the early clinical phases are able to make it to the later phases and then enter the commercial cycle. However, industry funding is now taking a direction towards clinical trials in this therapeutic area.
 
Nearly 25 percent of the total registered clinical trials are industry funded. Of the 25 percent industry funded trials, 40 percent of the funding is directed towards phase 1 of the research process followed by phase 3 and phase 2. About 30 percent of the total industry funded clinical trials are not having the listing related to the phase of the research. About 24 percent of the industry funded cardiovascular clinical trials are in phase 3 followed by nearly 16 percent of the total industry funded trials being in phase 2.
 
This is indicative of the fact that industry oriented and industry funded clinical trials in cardiovascular clinical research are able to find their path to completion. Trends show that an average of 88-95 clinical trials have been registered in the cardiovascular category starting from the year 2000 till 2015 by start phase for the top 10 indications of the cardiovascular category alone.
 
However, the regulatory approval timelines are a major hurdle to the cardiovascular clinical trial coming to market.
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Rashmi Pant is an expert in market research with more than 15 years of experience in major industrial sectors. She is also the owner of HOW TO: http://www.rashmipant.com/