Clinical trials: Australian prospective view

The regulatory agencies need to have pro-active approach in handling clinical trials throughout the globe. FDA as well as other regulatory bodies should continue to encourage unbiased gender and race participation in the clinical trials. Australia's National Health and Medical Research Council does ask researchers running trials whether they'll include equal numbers of men and women, but there's little follow up to enforce the guidelines. The sponsors should conduct sex analysis of the subjects enrolled at the clinical trial sites. Prospective design of clinical trials for sex analysis would provide more relevant statistical information. Trust, communication, education, and building a presence within the community are successful means to increasing diversity in clinical trials. Collaborative efforts are essential across all sectors of medical product research and development. Regulatory and review bodies must focus on patients needs and facilitate the clinical trial process. Phase III trials are not powered to assess trends in subgroups. In order to make an impact, analysis should be done in Phase III, not just post marketing studies. Manufacturers still want to make one size fits all, and also dont want to have to make many different dosages. There is a high prevalence of off-label and unlicensed drug use confirming that it is a widespread phenomenon. It is important for both the marketing authorization holder and national and international regulatory authorities to monitor for any consequential safety concerns and to take appropriate measures to address them, as well as to identify research priorities and mandate clinical studies to resolve important questions. Regulatory authorities should use existing clinical evidence on the use of off-label and unlicensed drugs in decision making and support conducting rigorous clinical trials only when necessary in order to fill the gaps in pediatric pharmacotherapy.It is my recommendation to t