Is full transparency in clinical trials an achievable goal? - European Journal of Internal Medicine

Abstract:  In the last two decades several requirements have been developed to enhance clinical trials transparency. Some are encouraged or recommended by ethics codes, journal editors, or funders. Others are mandated by national or supranational regulations or research institutions policies. From a global point of view, while prospective registration of trials and posting trial findings on a free publicly available register are the two most widely required or recommended requirements, others such as posting of protocols, statistical analysis plans (SAP), informed consent forms (which includes the participant information sheet) (ICF) on registers and sharing of anonymized individual participant data (IPD) are much less required or recommended. These differences are mainly due to three main reasons: a) whether the interventions assessed in the trials are regulated (drugs, biologics, devices) or not (e.g., behavior, surgery, diet, physical therapy); b) the institution or organization funding the research; and c) the country in which the sites involved in the research are located.