By: Aly Diana

Not long ago, a journal asked me to submit a clinical registration number for a pilot study I had conducted. I had registered my main randomized controlled trial (RCT), but not the pilot study. It turns out the CON-SORT statement includes a checklist for pilot and feasibility studies (the CONSORT checklist of information to include when reporting a pilot or feasibility trial), which was new to me. While the International Committee of Medical Journal Editors (ICMJE) rules and regulations on the registration of pilot studies are not entirely clear, I would encourage everyone to register their studies. In this case, more is definitely better. Registering RCTs, pilot studies, systematic reviews, and more to be on the safe side. Since there’s nothing wrong with it, it’s probably a good practice.

Reasons for Registering Studies

Clinical trials are indispensable for advancing medical knowledge and improving patient care. Registering these trials, particularly with platforms like ClinicalTri-als.gov (also known as the National Clinical Trial, NTC registry), is a critical process that ensures transparency, accountability, and accessibility of clinical research data. Clinical trial registration promotes transparency by providing a public record of all initiated studies, regardless of whether they yield positive or negative results. This practice is essential for preventing selective reporting, where only favorable outcomes are published, thereby reducing publication bias and offering a more accurate picture of the research landscape.

Moreover, registration fosters scientific rigor. By re-quiring detailed documentation of study protocols, researchers must specify objectives, methodologies, and statistical analyses in advance. This requirement minimizes the risk of data manipulation and enhances the reproducibility of results, contributing to the overall quality and reliability of scientific research. One of the most significant benefits of registering a study is the necessity of thinking through the statistical analysis plan before conducting the study. This planning stage helps in truly designing the study well. Although the registry itself may approve the registration without a clear or detailed statistical plan, some funders or journals have stringent regulations requiring this.

In addition, registration improves access to information, ensuring that data about ongoing and completed trials are available to researchers, clinicians, and the public. This fosters collaboration, prevents duplication of efforts, and accelerates the translation of research findings into clinical practice or community service. Furthermore, registered trials are viewed as more credible and trustworthy. Journals, funding agencies, and regulatory bodies often require registration as a prerequisite for publication or support, reinforcing the importance of this practice. Comprehensive trial registries also provide a valuable resource for systematic reviews and meta-analyses. These studies rely on complete datasets to draw robust conclusions about treatment efficacy and safety, ultimately guiding clinical decision-making. Additionally, ethical guidelines such as the Declaration of Helsinki emphasize the necessity of trial registration to protect participants and maintain public trust. By ensuring that trials are conducted ethically and responsibly with proper oversight and adherence to established protocols, registration upholds the ethical standards of clinical research.


In conclusion, the registration of clinical trials and other studies is a fundamental practice that enhances the transparency, ethical conduct, and scientific rigor of medical research. By adhering to registration requirements and CONSORT guidelines, researchers contribute to a more reliable and trustworthy scientific enterprise, ultimately benefiting patients and advancing healthcare knowledge.

The World Health Organization mentioned: “For the purposes of registration, a clinical trial is any research study that prospectively assigns human participants or groups of humans to one or more health‐related interventions to evaluate the effects on health outcomes.”
While reading, I found an article on common uses and misuse of pilot studies (cited here); maybe you can read or maybe we can discuss it another day.


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