5 October, 2019 - 08:39 (Research Matters)
The gold standard of any new product is measured based on its durability and efficacy. It is also true for new drugs that are made to cure existing or emerging diseases. These drugs cannot be administered directly to the patients without testing—they may help or harm our body. Some medicines may cause mild side effects, while a few could be life-threatening. Hence, every drug has to undergo ‘clinical trials’ to ensure it is safe for use.
Clinical trials are medicinal or observational experiments conducted on humans. The Food and Drug Administration (FDA), pharmaceutical industry, clinical trial registry databases, and policymakers are few of the significant entities that are involved in clinical trials.
FDA is an agency that regulates the standards and quality of the manufacturing of drugs to ensure the safety of public health. It holds the right to approve or reject a medicine to be publicly available. Pharmaceutical industries are involved in the discovery, development, manufacturing, and marketing of drugs. All pharmaceutical industries must follow the guidelines in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use-Good Clinical Practice(ICH-GCP) for conducting clinical trials.
The sponsor of the trial must register in clinical trial registry databases before starting any trials. A few of the databases are Clinical Trial Registry-India, ClinicalTrials.gov (US), Australian New Zealand Clinical Trials Registry and EudraCT (European Union). These databases are essential to record the status of the trials. They show if the trail is completed, terminated or suspended, the diseases studied, the number of successful tests, data availability from experiments, data analysis, sponsors, number of countries involved and more.
Researchers can make use of this data to implement the available experiment procedures, avoid previous mistakes, troubleshoot errors and get desired results. The FDA maintains an ‘Orange Book’ which can be used to identify the new drugs approved by it around the world. Thus, they improve the likelihood of finding a cure.
Policymakers are involved in reviewing the accuracy of the data in the database and in identifying discrepancies. Failure to catch errors might lead to misinterpretation of results and can hinder new ideas that can benefit the patient’s health or rights. Since lives are at stake, monitoring and regulating these clinical trials are mandatory.
In the end, everything in a clinical trial is related to how to cure patients. Ethics play a vital role as everyone involved in the trial need to be treated equally. Some patients could have even risked their lives to test a drug for the very first time, paving the way for saving more lives. Hence, stringent auditing, monitoring, and regulating these clinical trials can help researchers to create a healthy society.