How disclose the results of observational and phase IV studies
Andrea Rossi, Medical Writer - Eli Lilly

Much biomedical research is observational or occur when drugs are marketed. Despite the importance of such researches, the reporting of such research is often inadequate, which hampers the assessment of its strengths and weaknesses and of a study’s generalisability. Most pharmaceutical companies use to disclose the results of any study included in the Clinical Trials Registry, including observational studies conducted in the USA . Disclosing the results of a phase IV study is not, in principle, significantly different than disclosing the results of any other clinical trial. Even if any editor has its guidelines, the International Committee of Medical Journal Editors (ICMJE), and the Good Publication Practice (GPP2) are the reference for most of the writers, peer-reviewers and editors. Furthermore, principles to be followed while disclosing any result from clinical trials are continuously increasing and improving. They include any aspect of disclosure, from author’s definition and responsibilities to financial disclosure.

Some recommendations on what should be included in an accurate and complete report of an observational study is described in the STROBE statement.

The scope of the STROBE recommendations is to cover three main observational study designs: cohort, case-control, and cross-sectional studies. The STROBE statement is a checklist of 22 items that relate to the title, abstract, introduction, methods, results, and discussion sections of articles. 18 items are common to all three study designs and four are specific for cohort, case-control, or cross-sectional studies. A detailed explanation and elaboration document is published and is freely available on internet. The ICMJE and GPP2 guidelines and the STROBE Statement have contributed to improving the quality of reporting of clinical and observational studies.