Journal of Pharmaceutics & Drug Delivery Invites you to submit Your manuscript for 1st issue of 2020
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On the behalf of Editorial in Chief we are pleased to invite you for the submission of manuscript for the first issue of 2020 in month of March.
In this paper we will try to explain you about Clinical trials.
Clinical research is medical research involving people. There are two types, observational studies and clinical trials.
Observational studies: Observational studies observe people in normal settings. Researchers gather information, group volunteers according to broad characteristics, and compare changes over time. For example, researchers may collect data through medical exams, tests, or questionnaires about a group of older adults over time to learn more about the effects of different lifestyles on cognitive health. These studies may help identify new possibilities for clinical trials.
Clinical trials: Clinical trials are research studies performed in people that are aimed at evaluating a medical, surgical, or behavioral intervention. They are the primary way that researchers find out if a new treatment, like a new drug or diet or medical device (for example, a pacemaker) is safe and effective in people. Often a clinical trial is used to learn if a new treatment is more effective and/or has less harmful side effects than the standard treatment.
Other clinical trials test ways to find a disease early, sometimes before there are symptoms.
There are four phases of Clinical Trials-Clinical trials advance through four phases to test a treatment, find the appropriate dosage, and look for side effects. If, after the first three phases, researchers find a drug or other intervention to be safe and effective, the FDA approves it for clinical use and continues to monitor its effects.
Clinical trials of drugs are usually described based on their phase. The FDA typically requires Phase I, II, and III trials to be conducted to determine if the drug can be approved for use.
- Phase I trial- Experiments on small groups often on healthy people to know whether it’s safe or has side effects and find correct dosage.
- Phase II trial-Experiments on large group. Emphasizes on effectiveness. Aims to obtain preliminary data on whether the drug works in people who have a certain disease or condition. This can last for several years
- Phase III trial-Gathers more information about safety and effectiveness, studying different populations and different dosages, using the drug in combination with other drugs. If the FDA agrees that the trial results are positive, it will approve the experimental drug or device.
- Phase IV trial- A device or drug's effectiveness and safety are monitored in large, diverse populations. Sometimes, the side effects of a drug may not become clear until more people have taken it over a longer period of time.
Why Participate in a Clinical Trial?
There are many reasons why people choose to join a clinical trial. Some join a trial because the treatments they have tried for their health problem did not work. Others participate because there is no treatment for their health problem. By being part of a clinical trial, participants may find out about new treatments before they are widely available. Many people say participating in a clinical trial is a way to play a more active role in their own health care. Other people say they want to help researchers learn more about certain health problems.
Whatever the motivation, when you choose to participate in a clinical trial, you become a partner in scientific discovery. And, your contribution can help future generations lead healthier lives. Major medical breakthroughs could not happen without the generosity of clinical trial participants—young and old.
Thanks & Regards,
Journal of Pharmaceutics and Drug Delivery
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