One of the key purposes of clinical trials is to make sure that newly discovered medicines are tested, safe to use and effective. The medical consumption should not endanger humans and, respectively, should be absolutely risk-free when it comes to humans lives. In this regard, making sure that patients’ are safe and respecting their rights are two tasks of high priority. As part of Good Clinical Practice (GCP) standards and other regulations by the FDA, they should never be neglected. However, there is a much broader goal of clinical studies. Their performance aims at delivering results which, at the end, will turn out to be beneficial not only to the recipient but to the whole Pharmaceutical and Clinical industry as well. In other words, research projects can define the future of the medical world – they can equally improve it and/or deteriorate it.
Before the start of the testing procedures, there is a lot of work to be done. And this is not a secret. It is true that clinical trials which have already started involve lengthy and costly processes. But they become even more so time-consuming and resource-intensive due to various “pre-start” and “post-end” phases so to speak. Examples of such phases are trial registry and results submission.
What is the purpose of clinical trials registry?
In this article, we will focus on examining the pre-start procedure first, namely – clinical trials registry.
- First and foremost, registering clinical trials is crucial because it prevents any duplications in terms of research effort (choosing medicament, effects, testing, topics and so on). When one party is ready and wants to conduct a certain study, it is of a great importance for other parties and research organizations or institutions to know about already planned and started researches so that they can avoid wasting time on the very same one and can focus on another project instead.
- Secondly, rregistering clinical trials at their start contribute to the timely, well-prepared and accurate updates in the future. This is to say that clinical trials registry eliminates any risks of possible selective reporting of the trial progress and trial results and minimizes data violation.
- Thirdly, such registries help patients in case they want to check on the progress of the trial. The general audience also benefits from the whole process. How? They learn more about the trial itself, its goal and anticipated outcomes.
- In addition to this, clinical studies very often depend on resources which come from third parties. They rely on sponsorships and financial support which derives from external sources. In relation to this, trial registries also serve to promote better allocation and distribution of funds.
Finally, when it comes to ethical and institutional review boards (IRBs) as well as, clinical registrations give them an opportunity to define the appropriateness of a clinical trial far more easily and much more efficiently. What is more, they can consider and review the similarities between one research and another and check their relevance.
According to the International Committee of Medical Journal Editors (ICMJE), trial registrations are not merely a prerequisite but something really necessary for the smoothness of the trial performance. Such registrations are understood as a requirement that leads to better and more transparent publication of research results. Registration is accepted by the ICMJE in any registry that is an initial register of the WHO International Clinical Trials Registry Platform (ICTRP) or in ClinicalTrials.gov.
