By Marcia Kashawa, Research Nurse at ResearchNurses.co
1st June 2012
Historically King George III’s reign was the start of royal jubilee celebrations, which mark the significant reign of a monarch. Other British monarchs rarely reigned up to their Golden jubilees in the past, and for those that did it was amazing as to how they achieved this (4).That Queen Elizabeth II is celebrating a diamond jubilee is significant as only one other British monarch, Queen Victoria, has reigned long enough to celebrate a diamond jubilee (4). Jubilee celebrations have given the country cause for reflection on the many changes that have occurred over the years. It has also brought about a celebration of all things British, which should be remembered and celebrated. However, the impact of globalisation on the face of society and health cannot be ignored and so credit and blame has to be acknowledged also on its impact on society, health and industry (4). Over the Queens 60 year reign there have been many developments in health including drug research impact on treatment of diseases and long term conditions. Drug research in children has been far less in comparison to drug research in adults (3). Delving deeper into paediatric drug research over the last 60 years, interesting information has surfaced.
The challenges and responsibilities associated with drug research in children have been the limiting factors (2). Drug companies have had concerns with:
• Ethical issues which are more complex in children e.g. the need for more blood draws.
• Greater difficulty in carrying out research for children e.g. issues of consent and provision of suitable child friendly environments with suitable staff.
• The financial benefits of research in this area, as clinical research are complex and expensive.
The extrapolation of adult medication for use by children has raised ethical issues as it fails to factor in the safety and efficacy concerns. There are differences in organ maturation, metabolism and such that indicate the need for there to be more research in drugs for children. 70 to 80 % of medication used by children is off label or not licenced for use by children. This lack of clinical trials on children’s medication has been slowly improving over the past 60 years (2). The potential benefits from improved drug safety and efficacy for children are quite apparent and have influenced changes in legislation and regulation that have made it more conducive and less challenging for drug companies. (2, 3)
Developments over the years such as:
• American Academy of Paediatrics (AAP) first published “Guidelines for the Ethical Conduct of Studies to Evaluate Drugs in Paediatric Populations” in 1977.
• FDA modernisation Act 1997 (3)
• Paediatric Rule 1998 which came into effect in the EU in 2008
• Best Pharmaceuticals for Children Act 2002
• Provision of funding to study off patent drugs
• Cheaper costs and a larger pool of unwell children that can be recruited for research in developing countries, although this has also raised its own ethical issues.
“The benefits that biomedical research has brought to infants children and adolescents are remarkable. In recent decades research has helped change medical care and public health practices in ways that each year lengthens and saves the lives of tens of thousands of children around the world and reduces and prevents disability in many more and improves the quality of life for countless others,” (2). Though this improvement is of great significance policies and legislation governing drug research in children are still needed as they are a vulnerable group that is open to exploitation. Improved working together among drug companies, legislators and doctors and consumers is needed for there to be better progress (1).
Drug research in children has quite a way to go to improve the current statistics; however there is cause to celebrate the developments achieved as they have had a positive impact on children’s health and ultimately society has a whole. Not only has the country cause to celebrate the Queen’s long reign but also the impact that drug research has in had children’s health and the expectation of better achievements in the future.
1) Drug trials in children: Problems and the way forward: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2014901/
2) National Academy of Sciences (NAS, 1995) http://www.ncbi.nlm.nih.gov/books/NBK25549/
3) The trial and tribulations of doing drug research in children http://www.ncbi.nlm.nih.gov/pmc/articles/PMC236228/
4) The Queens Jubilee http://www.thediamondjubilee.org/past-jubilees
Marcia Kashawa (email@example.com) is a Research Nurse at Research Nurses Limited, trading as ResearchNurses.co, a specialist provider of Research Nursing services.