Category: Phase 1 clinical trial

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Clinical Trials 101

Phase 1 clinical trial

Clinical Trials 101

A clinical study is research performed by medical professionals and scientists with groups of people in order to better understand new medicine. This clinical drug development is critical in order to bring new drugs and medicines to the public. Without the medical research studies, there would be no way of knowing what sort of reactions a drug would have on the taker. There could be adverse side affects that could possibly harm large population of people. Instead, a clinical study is performed on smaller groups of people in order to conclude what any, if any, side affects taking a certain drug or medication could cause. Starting with the phase 1 clinical trial, the outline for a general clinical study is as follows:

1) In Phase I trials, researchers test an experimental drug or treatment in a small group of people (20?80) for the first time. The purpose is to evaluate its safety and identify side effects.

2) In Phase II trials, the experimental drug or treatment is administered to a larger group of people (100?300) to determine its effectiveness and to further evaluate its safety.

3) In Phase III trials, the experimental drug or treatment is administered to large groups of people (1,000?3,000) to confirm its effectiveness, monitor side effects, compare it with standard or equivalent treatments, and collect information that will allow the experimental drug or treatment to be used safely.

4) After completing Phase IV, the clinical trial team submits a New Drug Application (NDA) for approval to go on the market. Of the 5,000-10,000 drugs that annually enter RandD, only 250 make it to pre-clinical trial testing; only five make it to clinical trial testing; and only one makes it to FDA approval.

Reasons To Participate in Clinical Trials

Some 46 percent somewhat agree that taking part in clinical trials is as valuable to health care system as giving blood. Most of the time, participates of a clinical study are chosen based on a condition they have. They are then given the drug and the results, if any, are evaluated.

Everything You Need to Know About Informed Consent

If researchers plan on using children, defined as anyone younger than 18, in a study, they are legally required to obtain consent from their parent or guardian of the child. Informed consent is so important that in the 9th revision of the American Psychological Association’s Ethical Code it has its own section, 8.02. These statutes serve as guidelines that help keep minors safe and accounted for. Without them, underage children would participate in clinical drug development without the reliable, responsible knowledge of a parent or guardian.

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How Many Times Per Week Do You Take Pills Or Vitamins?

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How often do you think about the painkillers you take for a sore neck or the medication you rely on to soothe an asthmatic episode? We’ve all become accustomed to the benefits medical technology has on our everyday lives, to the point many forget the medical research studies that made it possible. Without a clinical study to properly test and evaluate the effects medication has on a varied and unique population there would be even more accidents and failures. Clinical drug development is the key to making sure we can all live a healthy and supportive life, no matter what.

What is the function of a clinical study? First and foremost it’s necessary to test a product in a safe and controlled environment to ensure it’s fit for its purpose. Each trial, also known as phase, needs to be followed closely. Medical standards change on a yearly basis and safety is always the most important factor to keep in mind for doctors, nurses and pharmacists. This is where terms like ‘informed consent’ come into play.

Informed consent is such an important aspect of the clinical study that the American Psychological Association’s Ethical Code recently gave it its very own section. For researchers that need to use children in a clinical study (as is defined by anyone under the age of 18), they are legally required to obtain the parent or guardian’s consent before proceeding. Failure to comply with these rules mean the clinical study will be unable to proceed.

The first trial, also known as Phase 1, requires that researchers test their experimental drug or treatment in a very small group of people. These are no smaller than 20 and no larger than 80, allowing the scientists to evaluate the safety and side-effects for the first time. Once the Phase 1 clinical trial has been completed they can move onto the second.

The second trial, also known as Phase 2 or Phase II, the drug or treatment will be given to a steadily larger group. These range from 100 to 300, depending, and the process is very much the same. According to a recent survey about clinical trials in the United States, over 90% of respondents said they have never participated in a clinical trial. Many researchers hope to spread awareness about the clinical study and the benefits it has on society on the whole.

The third trial is where the drug or treatment is administered to the largest groups of people, ranging from 1,000 to 3,000 and anywhere in-between. The studies have also expanded to explore not just side-effects, but compare it with equivalent treatments and how effective it is in the long-term. Once this is finished the last trial, or phase, can finally begin.

The last clinical trial sees the team submitting what’s known as a New Drug Application (or an NDA) for approval by the FDA. Of the nearly 10,000 drugs that enter every year, only 250 will make it to pre-clinical trial testing and only five to clinical trial testing. It’s estimated only one or two will actually reach FDA approval every year. Back in 1999 a clinical trial generally lasted 460 days. Compare this to 2005, where a clinical trial averaged nearly 800.

Without a careful and attentive clinical study many drugs and treatments would never make it to market to help people live their best life. The benefits of clinical drug development can be felt by adults and children alike. Will you offer your help this year?