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Clinical trials are a way to test new methods of diagnosing, treating, or preventing health conditions. The goal is to determine whether something is both safe and effective. A variety of things are evaluated through clinical trials, including medications, medication combinations, new uses for existing drugs, and medical devices
Clinical trials happen in several phases during which different questions are asked.
Each phase builds on the results of previous phases, Which are mandatory for every drug to go through these phases before getting approved and available in the market
Here’s a brief overview of each phase:
Clinical trials Phase 0:
This phase 0 of clinical trails is done with a very small number of people, usually fewer than 15.
Investigators use a very small dose of medication to make sure it isn’t harmful to humans before they start using it in higher doses for later phases
Clinical Trails Phase I:
During phase 1 of the clinical trails, investigators spend several months looking at the effects of the medication on about 20 to 80 people with no underlying health conditions. This phase aims to figure out the highest dose humans can take without serious side effects
Clinical Trails Phase II:
Clinical Trails Phase II involves several hundred participants suffering or diagnosed with the condition that the new medication is meant to treat. They’re usually given the same dose that was found to be safe in the previous phase. Investigators monitor participants for several months or years to see how effective the medication is and to gather more information about any side effects it might cause
Clinical Trails Phase III:
This Clinical Trails Phase III involves up to several thousand participants. The goal is to demonstrate that the medication is at least as safe and effective as existing treatments
Clinical Trails Phase IV:
Clinical Trails Phase IV happens after the medication has been approved by regulatory agencies and is available on the market. The goal is to continue monitoring its safety and effectiveness over a longer period of time and in a larger population
Clinical trials provide valuable information about the safety and efficacy of a drug before it is approved for marketing. However, even after a drug has completed Phase IV trials and received regulatory approval, ongoing monitoring is necessary to identify any potential safety concerns that may arise once the drug is used in a larger population.
Phase IV trials, also known as post-marketing surveillance or pharmacovigilance studies, continue to evaluate the safety and effectiveness of a drug after it is approved and made available to the public. These studies involve monitoring the real-world use of the drug, collecting additional data on its safety profile, and identifying any rare or long-term side effects that may not have been evident during earlier stages of clinical trials.
All Drugs which are through Clinical trials and approved May not work for everyone!
If you are taking a drug and find that it is not working as expected, it is important to consult with your healthcare provider. They can assess your specific situation, review your medical history, and determine the appropriate course of action. They may consider factors such as dosage adjustments, potential drug interactions, or the need to switch to an alternative treatment.
It’s crucial to communicate openly and honestly with your healthcare provider about your treatment experience and any concerns you have. They are best equipped to evaluate your response to the drug and explore other options if necessary. Additionally, they can help facilitate the reporting of any adverse events or concerns to the appropriate pharmacovigilance authorities.
Remember that the efficacy of a drug can vary between individuals, and sometimes it may take time to see the desired effects. It is essential to follow your healthcare provider’s guidance and communicate any changes or lack of response to your treatment. They will work with you to find the most suitable solution for your specific condition.
Vigilare Biopharma Pvt. Ltd.
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