What is Clinical Research?
Clinical research is a
branch of healthcare and biomedical science that determine the
safety and efficacy of medications, devices, diagnostic products and treatment
regimens which is intended for human use. It is the way to learn how to
prevent, diagnose and treat illness.
Clinical research is a
research which include both observational and interventional study on human
participants. The main perspective of these study to know the safety and
effective nature of drugs and other treatment regimens. Clinical research
basically conducted on those human participants who can be healthy volunteer or
patients. During the study, purposed protocol defines the risk and benefits of
clinical trial on human participants.
Clinical Trials
Clinical trials are research studies
that test how well new medical approach working on patients. In simple state, a
new medical approach test on human participants but this not an easy as it
sounds. A drug passes through different phases to reach clinical trials such as
- · Laboratory Phase
- · Non-Clinical Phase
- · Clinical Phase
In clinical trial a new treatment may
also compare to already available treatment content.
Why clinical trials important?
In growing world, new illnesses are
increasing rapidly. For every illness, we need to have cure. So new drugs are
coming into market but this is
not feasible to treat patients by using such drugs because without known
safety and efficacy profile of drug we can’t give them to patient directly. So,
it means if there are multiple illness, multiple drugs will come into market,
so drugs need to be administered for their safety and efficacy profile which can
be achieved by using clinical trials. Clinical trials measure safety and
efficacy profile of drug on large population and then measured drugs enter the
market.
Clinical trials come with a
staggering price tag. On average, pharma companies are spending anywhere
between $100 and $800 million per drug candidate.
Clinical trial outlook
Clinical trial market analysis, growth and
forecasts (2014-2025)
Globalization of clinical trial which
leads to increase the investment of new product in emerging countries thereby,
having a positive impact on overall market. The global clinical
trial market is expected to reach USD 65.2 billion, CAGR:5.7% by 2025,
according to a new report by Grand View Research, Inc.
As
the prevalence of diseases growing, clinical trial market will boost. Reports
also suggest that:
·
The
global clinical trials market is expected to grow at a CAGR of over 5.5% from
2017 to 2025.
·
Phase
III of clinical trial is expected to grow at fastest rate because it is long
duration trial on large population so more result will be obtained.
·
According
to various sources, more than USD 38.0 billion is currently being spent by the
healthcare industry towards preclinical and clinical development of oncology
therapy products.
According
to published report (Aug,2017) of grand view research, the global clinical
trials market size was valued at USD 40.0 billion in 2016 and is expected to
grow at a CAGR of 5.7% over the forecast period. New boosting demand for CROs
to conduct clinical trials developing.
According
to Bio Outsource, the demand for biosimilars testing is expected to increase in
the U.S. This is attributed to the fact that the FDA finally started addressing
the lack of clear guidance with regards to biosimilars, specifically how the
developers should prove that their drugs are like that of the originator
product.
U.S. clinical trials market, by phase, 2014 - 2025
(USD Billion)
Phase Perception
Clinical trials market, based on phase is classified
as Phase I, Phase II, Phase III and Phase IV trial services. According to U.S
clinical trials market, 2014-2015, rate of clinical trial phases increasing year
by year.
Due to investing in clinical trials, the
age-adjusted death rate in the US for coronary heart disease was cut in half
from 1980-2000. In fact, while half of the decrease is attributed to reductions
in cholesterol levels, blood pressure, and smoking. Since the success from
clinical trials has led to many benefits for patients, it was noted that more
funding is needed for cancer research. All these facts encourage the country to
do further clinical trials. As year by year rate of clinical trial increasing
and new regulatory amendments are set by the regulatory authority to maintain
patient’s safety, rights and wellbeing.
