Guidelines for designing, conducting, documenting, and reporting human nutrition randomized controlled trials (RCTs) have as yet to be developed and disseminated as reference for investigators, funders, regulators, institutions, assessors, trainees, and others involved in human nutrition research. Diet-related interventions can include diet and/or behavioral manipulation, provision of foods or entire meals, or delivery of dietary components in individual food items or supplements. This Perspective introduces a series of papers that outline core principles for the design and conduct of human nutrition RCTs, documentation and reporting of all aspects of clinical trial management, and data analysis and reporting of results. Human nutrition RCTs have unique considerations delineated in these papers. Conducting them with the highest scientific rigor is essential to the development of evidence-based dietary guidance for promoting optimal health and advancing health care.

UNASSIGNED: Several approaches to clinical trial monitoring, including the Risk Based Monitoring (RBM) are aimed at the protection of the human subjects (safety), improved data quality, and ultimately, reducing the cost of drug development and operations. There exists minimal evidence globally about the perceptions and the level of confidence among the clinical staff on the merits of RBM. The present study assessed the perception among clinical research staff globally (developed and emerging countries) on the applicability and adaptability of RBM.
UNASSIGNED: An electronic questionnaire survey consisting of twelve items was developed, validated, and then circulated globally via email to three thousand clinical research staff members at various investigational sites. This survey collected information on the use of RBM and factors that relate to clinical trial cost, data quality, subject safety, and the readiness to adopt RBM practices. The survey responses were summarized and analyzed by using the information e.g. responder\'s age, sex, clinical research role, global location, and experience in clinical research trials.
UNASSIGNED: Responses were received from ten countries, six emerging and four developed. Of the 3000 surveys sent to emerging (1,000) and developed (2,000) countries, a total response of 595 (261 vs 334) participants was received, respectively. The emerging versus developed group had 100 vs 137 participants with complete responses (CR); 34 vs 35 participants with partial responses (PR); and 127 vs 162 participants were disqualified with no exposure (NE) responses. About 67% of the overall responders were investigators, followed by 23%, 10% coordinator and other staff respectively. There was not significant difference in feedback between the researchers in developing versus emerging countries (p = 0.20) with regards to their perception of RBM reducing the overall cost of conducting a clinical research. Responders from emerging countries had a more favorable response than in the developed countries. Similarly, when asked if RBM will be more effective in addressing data quality (p = 0.006), patient safety (p = 0.05) and findings fraud/fabrication (p = 0.01), researchers from emerging countries indicated more confidence than researchers from developed countries. There was also a significant difference in the readiness to adopt RBM between responders of emerging versus developed markets (p < 0.0001).
UNASSIGNED: This unique study performed across ten emerging and developed countries strongly supported the need for systematic global training, education, and implementation of RBM regulatory guidance, with an aim for better safety of subjects and improved quality of clinical trial data. Furthermore, studies with larger sample sizes are recommended to provide an evidence-based approach.

BACKGROUND: In July 2012, the European Commission formalized the proposal for a European Clinical Trial Regulation that should replace the European Clinical Trials Directive 2001/20/CE. The new Regulation 536/2014 entered into force in June 2014 and it was expected to be applied not earlier than May 2016. Indeed, at the time, all required central tools are not yet available and new forecasts indicate it will become effective at the end of 2018. The aims of the Regulation are the promotion of higher standards in patient\'s safety and increasing transparency in Clinical Trials, also by changing the application process.
METHODS: An online survey was conducted among the Italian\'s Clinical Research Coordinators and Clinical Investigators to examine the perception and knowledge about the upcoming changes in Clinical Trials. A total of 190 Clinical Research Coordinators and 80 Clinical Investigators were surveyed.
RESULTS: Clinicians are less aware of the content of the Regulation than Clinical Research Coordinators, who demonstrate an extensive expertise on the topic (84.4%), mainly reached through self-training. The majority of the Investigators (74%) believes that their site\'s facilities and staff already met all the requirements imposed by the Regulation while Clinical Research Coordinators are less optimistic: 65.2% of them believes that the site staff is not yet fully aware of changes associated to its implementation.
CONCLUSIONS: The general opinion of the interviewed is that the new Regulation will strongly affect the trial management regardless of their type and phase, and the fulfillment of the imposed requirements represents an opportunity that Italy should not miss to increase its attractiveness to the pharmaceutical market.