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Saturday 20 January 2018
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Saving Lives One Step At A Time The History Of Clinical Research Trials

Phase 1 clinical trial

Have you ever wondered how you can do your part to help out the American healthcare system?

Some choose to donate blood to provide additional relief for victims of natural disasters. Others try to spread awareness in their state by providing people of all budgets and ages the information they need to get insured. Yet another way to provide assistance in the fluctuating American healthcare system is to participate in clinical trials. There are multiple benefits to a clinical study, perhaps most pertinent of all helping useful (and sometimes life-saving) drugs see the light of day.

The first detail you should know about clinical trials are their policies on consent. This is an important issue that can have many concerned about their rights when they participate in medical research studies, particularly if children or people with disabilities are also involved. Informed consent has its very own section in the 9th revision of the American Psychological Association Ethical Code. Researchers are not even allowed to use children in clinical drug development until they get the express permission of a parent or guardian first.

Clinical trials have a long and interesting history. They were first pioneered a few centuries ago, eventually arriving on our modern doorstep as a still irreplaceable part of the drug creation process. Although clinical trials are well-known, the vast majority of the population have never been involved. A recent survey found over 95% of respondents admitting they haven’t participated in a clinical study before. A supplemental survey on the importance of clinical trials saw 45% of people ‘somewhat agreeing’ that taking part in the process is just as valuable to the healthcare system as donating plasma.

Every clinical study is required to go through a series of phases before being deemed conclusive enough to present to the NDA. The first trial (also known as a Phase 1 clinical trial) is where researchers will test either an experimental drug or treatment to a small group of people. Since this is the very first phase, the group will be no smaller than 20 and no larger than 80. Over the course of multiple weeks its safety and side-effects will be closely documented so the next stage can begin. Anything lackluster will have to be pulled and considered inconclusive.

Much like the first trial, the second trial will have the drug or treatment method administered to a larger group. This one is as small as 100 and as large as 300. The third trial is the largest of all and has the treatment given to a group as large as 3,000 to get the widest range of results possible. It’s only after the third trial has been concluded do the researches have enough information to present their work to the NDA. A New Drug Application is a formal application with rigorously high standards that only get higher by the year. With people’s livelihoods (and sometimes lives) depending on this medication, the margin for error needs to be as small as possible.

Over 5,000 new drugs will enter the RandD every single year. A mere 250 will actually make it to pre-clinical trial testing and just five will actually be deemed safe enough to test in clinical trials. How many reach the approval of the FDA (or Federal Drug Administration)? Just one. That should give you a good idea as to the necessity of new applicants. The American healthcare system is expected to go through massive changes over the next few years, but the demand that has never changed is help for clinical drug trials. The average clinical trial back in the 1990’s lasted 460 days, but nowadays the timeframe is closer to 800 days.

You have a hundred different ways to help out your fellow man. Clinical trials is an effective and highly viable way to make sure millions of people can lead the healthiest life possible.




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