Clinical research studies

The following items are mandatory in clinical research studies:

1) Title: it should be as brief and objective as possible without sacrificing accuracy. Be descriptive and prefer specific terms rather than general ones and, if possible, state the type of study. Avoid using commercial names.

2) Introduction and objectives: this section should contextualize the clinical problem, highlighting its relevance and identifying the scientific gap that the study may help to fill. The objectives should clearly and concisely define the purpose of the study, making hypotheses to be tested perceptible. Ideally this should be done in a single sentence, without repeating or rephrasing the description used in the title.

3) Materials and methods: description of the materials used, the experimental design of the study and the methods. If appropriate, include the way statistical analysis was performed. You may briefly mention, according to the type of study, the following items: description of materials (generic names of drugs and equipment should be used, unless brand identification is crucial for the study), experimental design, participants (sample size, eligibility criteria, screening site), interventions, outcomes (clearly define the primary outcome), methods of allocation, calibration and blinding, intervention/evaluation times and type of statistical analysis (tests and level of significance).

4) Results: a clear summary of the results should be presented. It should mention some specific data representative of the results of the study. Do not reference information that does not correspond to the data in the presentation. Vague, non-specific sentences, such as “the results will be discussed in the presentation”, will not be accepted. Highlight the primary outcome of the results for each experimental group, and the size and precision of the estimated effect. If relevant, mention adverse or secondary effects.

5) Discussion: this section aims to provide a consistent interpretation of the results, by considering their applicability (external validity) and the potential risks and benefits, and by integrating these observations with the applicable evidence. The limitations of the work should be mentioned, indicating potential sources of bias and inaccuracy.

6) Conclusions: briefly mention, preferably by topics, the main objective conclusions reached by the study that respond to the formulated objectives or hypotheses. The conclusion may include implications of the study in the context of the current evidence and changes to be implemented as a result of the research.

7) Final indication of funding sources (if any).

8) Conflict of interest disclosure statement (if any).

In clinical research studies, the registration of the research study (registration number and name of the study) must be indicated in the form by filling in the field for this purpose.

Research studies conducted on humans, including those using human cells, tissues and/or data, require prior authorization by an ethics committee, which must be attached in the submission form in the field provided for that purpose.