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The National Health and Medical Research Council (NHMRC) is the main statutory authority of the Australian Government responsible for medical research. It was the eighth largest research funding body in the world in 2016, [ 1 ] and NHMRC-funded research is globally recognised for its high quality. [ 2 ]
The DRKS is an open access, free of charge online register for clinical trials and is available both in English and German. DRKS is part of the WHO's ICTRP. The DRKS works with two partner registries in Germany, DeReG (German Registry for Somatic Gene-Transfer Trials) and Clinical Trial Registry of the University Medical Center Freiburg. [4]
The Therapeutic Goods Administration (TGA) is the medicine and therapeutic regulatory agency of the Australian Government. [4] As part of the Department of Health and Aged Care, the TGA regulates the safety, quality, efficacy and advertising in Australia of therapeutic goods (which comprise medicines, medical devices, biologicals and certain other therapeutic goods).
The main product of the CONSORT Group is the CONSORT Statement, [1] which is an evidence-based, minimum set of recommendations for reporting randomized trials.It offers a standard way for authors to prepare reports of trial findings, facilitating their complete and transparent reporting, reducing the influence of bias on their results, and aiding their critical appraisal and interpretation.
Clinical monitoring is the oversight and administrative efforts that monitor a participant's health and efficacy of the treatment during a clinical trial.Both independent and government-run grant-funding agencies, such as the National Institutes of Health (NIH) [1] and the World Health Organization (WHO), [2] require data and safety monitoring protocols for Phase I and II clinical trials ...
For trials where the response rate is the primary endpoint it is strongly recommended that all responses be reviewed by an expert(s) independent of the study at the study's completion. Simultaneous review of the patients’ files and radiological images is the best approach. Reporting of results
A large number of hierarchies of evidence have been proposed. Similar protocols for evaluation of research quality are still in development. So far, the available protocols pay relatively little attention to whether outcome research is relevant to efficacy (the outcome of a treatment performed under ideal conditions) or to effectiveness (the outcome of the treatment performed under ordinary ...
The Belmont Report: Ethical Principles and Guidelines for Protection of Human Subjects of Biomedical and Behavioral Research (1979) These reports contained their recommendations, [ 10 ] the underlying deliberations and conclusions, [ 11 ] a dissenting statement and additional statement by commission members and summaries of materials presented ...