Have you considered participating in a clinical study recently? It’s important you know the purpose of clinical drug development as well as your rights when being analyzed by medical staff. The function of a clinical study is to assist the medical industry in their research, helping them better develop a wide range of products for the American population through consistent testing, research and ongoing feedback. If you’re not sure how the process works, consider reading below to brush up on your terminology and gain a larger picture of clinical trials as a whole.
What Are My Rights?
One of the most important elements of a clinical study is that of active, informed consent. This is so vital that the 9th revision of the American Psychological Association’s Ethical Code has its own section on the matter. If researchers plan on using children (defined as anyone younger than 18), they are legally required to obtain consent from the parent or guardian.
What Is A Phase 1 Trial?
The first step in any clinical study involves the active consent of multiple participants. A Phase 1 clinical trial begins with researchers testing an experimental drug or form of treatment on a small group of people, consisting of anywhere between 20 and 80 people, for the first time. Over a regulated period of time the safety and side-effects of said drug or treatment will be actively evaluated.
What Is A Phase 2 Trial?
Should the first trial prove successful, researchers and scientists will then move the experimental drug or treatment to a larger group of people (at around 100 to 300, depending). Much like a phase 1 clinical trial, the goal is to study minor to severe side-effects as well as interactions and benefits. The average clinical trial back in 1999 lasted 460 days, whereas this number has increased to 780 in recent years.
What Is A Phase 3 Trial?
Following a phase 1 and phase 2 trial, the third one continues to expand upon already existing knowledge. This group of people numbers at 1,000 at the least and 3,000 at the most. At this point there is enough information to allow the experimental drug or treatment to reach a safe consensus for a wide group of people. However, there is one more trial that must be done before the medical research studies are considered conclusive.
What Is A Phase 4 Trial?
Last, but not least, a phase 4 trial involves the clinical team to submit what is known as a New Drug Application (shortened to NDA) for approval. Of the 5,000 to 10,000 drugs that annually enter the market, only 250 make it to pre-clinical trial testing and only five will actually be involved in a clinical study. Overall, the FDA approves one or two on average for mass marketing and consumption.
Should I Participate In A Clinical Study?
Clinical drug development is necessary to ensure that medical products are safe for human exposure and consumption. Nearly 47% of respondents to a recent survey ‘somewhat agree’ that taking part in clinical trials is as valuable to the health care system as donating blood or plasma. Another survey concerning clinical trials in the United States had 96% saying they never participated in a clinical study. From the initial phase 1 trial to the final approval stage, clinical trials are the bridge between the country and a better future.