Clinical Research and future scope

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.