Conducting research involving human participants carries a significant responsibility to uphold ethical principles that protect their rights, safety, and well-being. Ethical oversight is a fundamental aspect of credible scientific research.

In the case of clinical trials, studies that produce evidence to guide healthcare decisions and improve patient outcomes, there are additional requirements that strengthen transparency and public trust.

Here, we will discuss registration, reporting and data availability statements that need to be considered when submitting your research for publication.

What are clinical trials?

Clinical trials encompass any study that prospectively assigns participants to interventions with the aim of assessing health outcomes. This broad definition includes not only pharmaceutical or hospital-based studies but also any research involving participant randomization or group classification around an intervention.

According to the National Institute of Health (NIH), a clinical trial is a research study in which one or more human subjects are prospectively assigned to one or more interventions to evaluate the effects of those interventions.

The NIH also provides 4 questions to help authors determine if their research falls under the category of a clinical trial:

• Does the study involve human participants?
• Are the participants prospectively assigned to an intervention?
• Is the study designed to evaluate the effect of the intervention on the participants?
• Is the effect that is being evaluated a health-related biomedical or behavioral outcome?

Answering yes to all 4 questions indicates that the study is indeed a clinical trial according to the NIH definition.

Even if the study does not include a placebo or comparison group, or if the research is only studying the safety or dose of a drug, the study is still classified as a clinical trial.

The World Health Organization (WHO) also has a similar definition of clinical trials that highlights the importance of volunteers that take part in clinical trials.

When and where to register a clinical trial

According to the Declaration of Helsinki, medical research involving human participants must be registered in a publicly accessible database before recruitment of the first participant.

Trial registration creates a public record of the study’s design and objectives, helping to prevent selective reporting and ensuring greater transparency in the research process. It also helps keep the public informed of planned trials they might want to participate in and prevents the duplication of studies.

These registries can also be used by institutional review boards when considering ethical approval for a study. They can search for similar studies and review the risks and available data.

To comply with requirements, authors must register their clinical trials in an established registry. Authors can choose a registry listed by the World Health Organization Registry Network or those approved by the International Committee of Medical Journal Editors (ICMJE).

These platforms meet the content and quality criteria set by the WHO and include platforms such as:

• gov
• ISRCTN
• EU Clinical Trials Register

Authors should also check with their funders to see if they are required to use a specific registry.

The registry name, trial registration number, and date of registration should be clearly disclosed within the Institutional Review Board statement or the methods section of any resulting publication.

It is also important to emphasize that ethical approval from an Institutional Review Board or ethics committee, while mandatory, does not substitute for trial registration. Both processes serve distinct but complementary roles in the ethical and scientific oversight of clinical research.

Reporting bias free results

Researchers have an obligation to disseminate the findings of their research on human participants. The WHO recommends that results be reported within 1 year of the study’s completion, although when publishing in a journal, an allowance of up to 2 years is suggested.

To promote clear and comprehensive reporting, authors of clinical trials are encouraged to follow the CONSORT 2025 guidelines. These tools help ensure that trial results are reported with the rigor and detail necessary for reproducibility and critical appraisal. The guidelines provide authors with a checklist of 30 items and a flow diagram that guide the authors on how to structure their manuscript and what information they should include in each section.

Reviewers and academic editors are also encouraged to follow the checklist when evaluating the article to ensure the trial reports are clear and transparent.

By rigorously following these guidelines, researchers not only comply with international standards but also strengthen the credibility and ethical integrity of their clinical trial research, ultimately benefiting the broader scientific community and public health.

Data sharing statements

There are several benefits to sharing clinical trial data, but of course there are also risks. These all need to be considered carefully even before participant recruitment commences.

Potential benefits include the acceleration of scientific progress, facilitation of secondary analyses which reduces cost and brings new benefits, and potential improvement in patient outcomes and public health. Risks include invasion of privacy, breaches of confidentiality, or even potential harm to society if the data are distorted or incorrectly evaluated.

Starting from the planning stage, authors are encouraged to analyze the risks and complete a data sharing plan. Learn more about how to create a data management and sharing plan here.

ICMJE has developed a data sharing statement policy that applies to all clinical trials. Authors are required to indicate if individual deidentified participant data will be shared, what specific data will be shared and when. They provide authors with a table of data sharing statements as examples that would meet their and many publishers’ requirements.

MDPI is committed to supporting open scientific exchange and enabling our authors to achieve best practices in sharing and archiving research data. To achieve this goal, MDPI requires all articles to include a Data Availability Statement. To assist authors, a list of example statements is provided on the Research and Publication Ethics page.

Ensuring ethical and open scientific exchange

Clinical trials are essential for advancing medical knowledge, as they provide reliable evidence on the safety and efficacy of new drugs, interventions, devices and diagnostics. Medical professionals rely on clinical trials to make informed healthcare decisions. It is therefore important that these decisions are grounded in transparent, high-quality scientific data.

Registering clinical trials, reporting the data in a structured manner according to industry standards, and sharing the results openly and timely all contribute to strengthening transparency and public trust.

MDPI is committed to ensuring that all research conforms to the highest publishing standards and is conducted ethically and responsibly.

Visit our Research and Publication Ethics page for more guidance on registering clinical trials and reporting guidelines.