Participation of women, children and elderly in the clinical trials: Australian prospective view

Saba Nabi, George John, Patrick Ball, Parikshit Basu

Research output: Other contribution to conferenceAbstractpeer-review


Life expectancy in Australia is 79.3 years for men and 83.9 years for women. Australia is predicted to see a substantial increase in the number of frail older people. An essential component of medical care is Pharmacotherapy and it's estimated that around two-third of Australians over the age of 60 use four or more drugs. Exclusion of older adults as clinical trial participants is highly problematic because they suffer high rates of Cancer,Cardiovascular Disease, Dementia, Arthritis and Parkinson's disease. The health care system in Australia has to successfully manage an increasing absolute number of frail older people with multiple co-morbidity and disability. It has been documented for years that female have been underrepresented in the clinical trials in the New Drug Application (NDA) and Investigational New Drug Application (INDA) which are being approved before the marketing.The issue of the underprivileged position of children with respect to the drug therapies or their participation in the clinical trials was raised years ago, but the situation remains inadequate. Children are routinely given drugs that basically lack the specific pediatric information because of facing the difficulty in carrying out clinical trials in this population, such as practical difficulties and ethical considerations arising from the involvement of children.The regulatory agencies require a Pro-active approach in handling clinical trials throughout the globe. The FDA and other regulatory bodies should continue to encourage unbiased gender and race participation in 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 analysis of distribution of the sexes of subjects enrolled in clinical trials. The prospective design of clinical trials for analysis of gender would provide more relevant statistical i
Original languageEnglish
Number of pages1
Publication statusPublished - 2014
Event5th FIP Pharmaceutical Sciences World Congress - Melbourne Convention and Exhibition Centre, Melbourne, Australia
Duration: 13 Apr 201416 Apr 2014


Conference5th FIP Pharmaceutical Sciences World Congress
Abbreviated titlePharmaceutical Sciences beyond 2020 – The rise of a new era in healthcare
OtherOne exciting venue, where the leading pharmaceutical scientists from across the globe will meet to discuss the future: Where will the pharmaceutical sciences stand beyond 2020? What should be your focus? What will be the breakthroughs and the pitfalls? How can we meet the biggest challenges? Join us in dynamic Melbourne and discover how we are on the verge of a new era in healthcare.
Co-sponsored by many of the world’s leading pharmaceutical science and educational organisations, the International Pharmaceutical Federation (FIP) is pleased to bring the 5th PSWC to Melbourne, Australia in 2014.
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