The Food and Drug Administration (FDA) is a regulatory body involved in the various stages of the drug development process to ensure to mitigate public health concerns to mark the safety of drugs for public use. In the drug development process, clinical trials are critical and time-consuming aspects that determine the safety and efficacy of the drug. Moreover, the relevant data is important to get the FDA’s marketing approval for the drug. This blog post is an informative guide about the oversight of the FDA to ensure the integrity of various phases of clinical trials. Let’s get started.
Understanding the Phases of Clinical Trials
The phases of clinical trials are almost the same worldwide. However, the regulatory authority differs in each region in the US it is the FDA and in Saudi Arabia, it is the SFDA clinical trials monitoring authority. Here are the major phases of clinical trials under the influence of the FDA.
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Phase 1
Phase one of a clinical trial is focused on studying the pharmacokinetics and pharmacodynamics of the drug under study. In phase 1, a bunch of healthy individuals (20 to 80 in number) volunteer to participate in the clinical trial. This phase is focused on monitoring the adverse effects of drugs on healthy individuals that can lead to serious health concerns like organ damage, birth defects, and even death. Phase 1 of the clinical trial lasts for months.
After the end of the trial period, the data is collected, analyzed, and presented to the FDA. If the results meet the outcomes from the drug design, the FDA will approve the result and allow the researchers to move to the second phase. Otherwise, the trial is aborted at the first stage. This phase is usually skipped if the drug under study is pre-approved for another disease undergoing trials for repurposing.
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Phase 2
This phase determines the dose, route of administration, and efficacy of the drug under study. The participants (100 to 300 volunteers) in phase 2 of clinical trials are patients of that particular disease. In the study design of phase 2, the researchers divide the volunteers into different groups who receive different doses of drugs with different administration routes. There is also a control group that gets the available treatment or placebo for the validity of clinical trials.
In the data processing part of the trial, researchers determined which dose and route of administration of the drug had the most positive results. Moreover, if there is already an available drug for that disease, the result of both drugs is compared to ensure that the new drug is more efficient with the least adverse effects for the disease treatment. The FDA analyzes all the data to decide if the trial sponsors can move to the next phase or not.
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Phase 3
Phase 3 of clinical trials involves a large group of participants (300 to 3000 individuals). It determines the safety and efficiency of drugs in a large community including people of various ages and health concerns. Apart from the number of individuals, the remaining study design is almost the same as for phase 2. At the end of phase 3, the drug outcomes from the study groups are compared to the control group.
The results must indicate the better efficiency of the drug as compared to the available treatments. Moreover, there should not be any acceleration of disease or the other drug’s side effects. If the results meet the standards, the FDA permits to apply for a New Drug Application (NDA), and all the collected data is submitted as supporting documents. After NDA submission, the FDA takes all the data into account and decides on giving the sales approval to the manufacturers.
Final Words
The above three phases are critical in the drug development process to get FDA approval for mass production and drug distribution in the market. However, the role of the FDA does not end here. There is a fourth phase, post-market surveillance in which the FDA keeps collecting data about the drug from healthcare professionals, sponsors, and patients to study the long-term effects of the drug. In short, the role of the FDA lasts until a drug persists in the market.