Clinical Trials may be defined as voluntary research studies, conducted in people, that are designed to answer specific questions about the safety and/or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments. (Courtesy: FDA). Clinical trials have been existent since eleventh century wherein the learned lot of those times tried, tested and laid regulations for experimental use and testing of drugs and other related substances. Today in the 21st century, we have a whole population across the globe working on prevention and cure of diseases with latest technologies and science in a regulated environment put down by governing authorities and bodies like FDA, HIPPA, CDISC and others.
Clinical Trials can be classified into:
1. Observational Study
2. Interventional Study
There are different types of Clinical Trials specified by US NIH (National Institute of Health) as:
1. Prevention trials: look for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, vitamins, vaccines, minerals, or lifestyle changes.
2. Screening trials: test the best way to detect certain diseases or health conditions.
3. Diagnostic trials: conducted to find better tests or procedures for diagnosing a particular disease or condition.
4. Treatment trials: test experimental treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.
5. Quality of life trials: explore ways to improve comfort and the quality of life for individuals with a chronic illness (a.k.a. Supportive Care trials).
6. Compassionate use trials: provide experimental therapeutics prior to final FDA approval to patients whose options with other remedies have been unsuccessful. Usually, case by case approval must be granted by the FDA for such exceptions.
The clinical trials process may be categorized into four major phases namely:
1. Phase I - Phase I trials are the first stage of testing in human subjects.
2. Phase II- Once the initial safety of the study drug has been confirmed in Phase I trials, Phase II trials are performed on larger groups (20-300) and are designed to assess how well the drug works, as well as to continue Phase I safety assessments in a larger group of volunteers and patients. When the development process for a new drug fails, this usually occurs during Phase II trials when the drug is discovered not to work as planned, or to have toxic effects.
3. Phase III -Here studies are randomized controlled multicenter trials on large patient groups (300–3,000 or more depending upon the disease/medical condition studied) and are aimed at being the definitive assessment of how effective the drug is.
4. Phase IV - Phase IV trial is also known as Post Marketing Surveillance Trial. Phase IV trials involve the safety surveillance (pharmacovigilance) and ongoing technical support of a drug after it receives permission to be sold.
Well, this is just a brief overview of what can be a Clinical Trial. It would come as an astonishing fact to those who are looking at it for the first time... This industry is typically conservative and a lot of people do not know what actually goes behind the scenes while making a drug. This industry is regulated by major regulatory and compliance authorities. There are a lot of other interesting things that make this a booming sector - EDC - Electronic Data Capture, ePRO- Electronic PRO, mPRO- Mobile PRO, about which I shall discuss in my forthcoming blogs.
Happy reading !! :)
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