Clinical trial registries are data collecting tools that are typically used for a better understanding of long-term trends of a specific population. This population generally includes those with a particular form of disease or exposure to a particular drug, treatment, or medical device. When registries are designed properly, they can be used as data sources within which any number of Clinical Research trials can be carried out.
Clinical trial registries are used not only for supporting the safety evaluations but also for efficient evaluations, which is a newer practice. The FDA has flagged a commitment to developing policies regarding the use of registries and other forms of real-world evidence for clinical research trials. The practices for designing and assessing registries are outlined in such a manner that they are able to meet the expectations of the FDA to review new products, drugs, medications, or treatments. The recommendations provided by the FDA can be applied to existing registries as well as developing registries. The sole aim of these practices is to improve the leveraging registries in order to facilitate high-quality clinical research trials at substantially lower costs.
Medical sciences and technology have made rapid advances, with new therapeutic options being designed at a phenomenal rate. However, clinical trials have been undertaken without the appropriate measures and protocols. There have been instances of several drugs being withdrawn from the market due to newfound reports of unethical trials being conducted. A series of these events has led to the greater need for transparency of clinical trials all over the world. Thus, registration of clinical trials and their public display of all the trials prior to the enrollment of the first test subject is identified as the way to bring in transparency as well as the accessibility of all clinical research trials for the concerned authorities as well as the public.
Apart from this, clinical trial registries are also expected to help in removing the publication bias by bringing all the clinical research trails (positive and negative) into the public domain. This also helps in reducing the duplication of results and research.