What is clinical and How important is it?
Nowadays, healthcare is the top concern from each individual to nation. The researches reveal that annual average expenditure for healthcare is increasing but “we spend 50x more treating people who are sick than we spend finding cures” – Mark Zuckerberg’ commencement speech at Harvard in May 2017. In Asia, excluding developed nations such as Japan, HongKong, Korea,…the clinical research (Research for new treatments and carings )hasn’t been considered as expected. The total number of clinical trials in Southeast Asia equal only 5% of USA one.
What is clinical trial?
According to NIH (National Institutes of Health), the definition of clinical trial is “Clinical trials are part of clinical research and at the heart of all medical advances. Clinical trials look at new ways to prevent, detect, or treat disease. Treatments might be new drugs or new combinations of drugs, new surgical procedures or devices, or new ways to use existing treatments. The goal of clinical trials is to determine if a new test or treatment works and is safe. Clinical trials can also look at other aspects of care, such as improving the quality of life for people with chronic illnesses.”
Count to 25th July 2017, Clinicaltrials.gov (Global Clinical Trials registration site ) announce that the number of clinical trial registration grow by 37% from 2014. USA one appropriate 37%, other ones hold 47%, Both of the USA and other ones hold 6% and un position land takes left part.
Typically, trials are conducted in four phases:
– Phase one is when generally healthy people are given the medication to test if the ingestion of the pill or treatment will have no adverse, toxicological effect;
– Phases two and three dive deeper into the safety, effectiveness, and dosage of the medication, and it’s after these stages when the FDA would approve the drug or device; and
– Phase four examines new uses for previously approved treatments.
With the promise of marketing authorization, though far ahead in the road, hanging on the horizon, the approval of a clinical trial usually attracts investors and leads to a respectable rise of the company shares. However, everything comes at a price. Clinical trials are not without risks, and while the perspective of success is encouraging, the crude reality is that most compounds fail before reaching the market. As explained in previous entries, despite higher R&D expenditures, attrition rates are high and, what is worse, on the rise. “Data collected between 1990 and 2004 show that the number of unsuccessful clinical trials has been steadily increasing during the last years: from 30% to 50% at Phase 1, from 40% to 70% at Phase 2 and from 20% to nearly 50% at Phase 3,4. As a result, less than 10% of the drugs that enter clinical trials end up being approved by regulatory agencies” as NCBI noted.
According to Ken Getz, founder and chairman of the Center for Information and Study on Clinical Research Participation (CISCRP) “there’s no question that clinical trials will play a large and growing role in the medical options”. In fact, nearly 4,000 experimental drug therapies are in active clinical trials today and that number will continue to grow as improvements are made in detecting disease, in understanding the root causes of acute and chronic illnesses, and in discovering medical innovations.
Mr. Getz also predicted that “in the not-so-distant future it will be more common for clinical trials to be discussed during routine visits with the doctor as electronic health records and clinical research converge.” This prediction is much different from how most people stumble upon clinical trials today.
Diversity in Clinical Trials
Clinical trials are an essential part of drug development. These provide a base of evidence for evaluation of a drug. Each drug needs to be tested for its efficacy, ease of application, side effects, and many other factors before being launched into the market. The average medicine developed by a major pharmaceutical company costs billions of dollars to develop. In general, the drugs are not specifically designed with every racial group in mind due to the cost of production. That is why clinical trials are an important tool to determine the medicine’s effectiveness in the population as a whole. The trials are performed on a sample population and researchers try to prove its statistical significance on the entire population. Hence, it is very much essential for clinical trials to be diverse to represent the population. People from diverse cultures differ among factors such as their predisposition to diseases or the environment they are exposed to. To create awareness, the FDA announced 2016 as “The Year of Diversity in Clinical Trials.” Despite an increase in awareness, the current trend is unsatisfactory. According to the FDA, African Americans represent 12 % of the U.S. population, but only 7% of clinical trial participants. Additionally, Hispanics represent 16% of the U.S. population but only 1% percent of clinical trial participants2. In a country where minorities are estimated to outnumber white Americans by 2044, the inclusion of individuals of varied races, ethnicities, ages, gender, and sexual orientation in clinical trials can help to prevent disparities in the evaluation of potential new medicines. Clinical trials ensure top quality drugs and diversity in clinical trials should be considered to provide better treatment.