Clinical Trial Registry Role and Their Regulations

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.

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 There have been instances of several drugs being withdrawn from the market due to newfound reports of unethical trials being conducted.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.

Fear of plagiarism of their intellectual property

Reluctance to an early release of sensitive information to the general public

The decrease in the market value of the investigational medical product

Decrease in profit due to information being known to rival or competitor companies.

Despite these concerns, complying with international standards is mandatory for filing copyrights or patents.

Keeping up with the latest developments is the primary function of the clinical trial registries. Keeping these developments in mind, the concerned registries are currently in the process of developing or creating the standard structure format of results for disclosure based on the international standards for interventional trials covering a few points or criteria.

These criteria include:

• The overall patient population of the region under consideration.
• The baseline characteristics of the trial.
• The primary outcomes of the trial.
• The secondary outcomes of the trial.
• The adverse or negative results of the trial.

According to the World Health Organization (WHO), the registration of all clinical trials across the globe is a scientific, ethical, and moral responsibility. Thus, it makes the clinical research trial registration a publication of all the information of the trial. The information includes aspects concerning the design, administration, and conduct of the entire trial. They are also required to post extended details like the summary and other relevant aspects to ensure transparency. This registry should be accessible to the public at no cost. It also is available to all the prospective registrants who are managed by a separate organization who have the ability and mechanism to ensure the validity of the data registered.

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