In this section
To address the imbalance between adult and paediatric drug therapy through the conduct of clinical trials which aim to improve the safety and efficacy of therapies for children.
To improve the health outcomes for women and children by providing and promoting innovative services, research education and advocacy in partnership with other health providers and the community.
The Australian Paediatric Pharmacology Research Unit (APPRU) is a specialised unit and is one of only six other similarily dedicated units worldwide (outside the US). The unit conducts clinical trials in children to investigate the safety and effectiveness of prescription drugs and medications typically developed for adults.
To facilitate and promote paediatric labelling of new drugs or drugs already on the market.
Up to 80% of medications marketed today are not approved for use in neonates, infants, children and adolescents. That is, most of the drugs that are prescribed for children have never been tested on children.
A doctor faced with a sick young patient often has two options: to give a smaller dose of a drug licensed for use only on adults or not to give the drug at all. In some cases, manufacturers or doctors' groups have recommended dose schedules for children, but in others they haven't. Then it's a case of relying on their own experience and that of others.
There is no easy extrapolation from adult studies to children because the physiological systems of a child are different from adults and the results of medication can be very different.
Based at the Royal Children's Hospital:
Experienced with FDA Written Requests and Responses
Access to paediatric patientsExpertise in ethical issues surrounding paediatric trialsClinical trials involving paediatric patients require additional consideration to protect this vulnerable population. Close review is given to every protocol and informed consent form.
Dissemination of findings
APPRU maintains a strong academic mission and encourages the publication of results from the trials that it manages. Its leaders assist with preparation and submission of manuscripts to peer-reviewed medical journals and presentations at national and international meetings. APPRU is committed to the sharing of new information that will contribute to the advancement of pediatric therapies.
Established to facilitate high quality clinical trials in children, the unit is run by a dynamic, multi-disciplined team of professionals who have extensive clinical trial experience. Staff in the unit have collaborated on many clinical drug trials involving various clinical specialties. These range from phase I to phase IV studies, single-centre and international multi-centre trials, and include a number of pharmacokinetic, bioequivalence and pharmacodynamic studies.
The APPRU is located at the Royal Children's Hospital, Melbourne, which has an international reputation as a centre of excellence for research and clinical practice. It provides a comprehensive range of clinical services and it is a referral centre for highly specialised areas such as cardiac surgery, genetics and intensive care. It has 250 inpatient beds and serves 32,000 inpatients and 248,000 outpatients each year. The hospital enjoys strong local community support, receiving donations of time and money from a variety of local charities. A yearly telethon raises several million dollars for the hospital each year.
The Murdoch Childrens Research Institute (MCRI) combines cutting-edge scientific and clinical research with first-class public health services. Its research covers asthma, childhood cancers, diabetes, infectious diseases, genetic diseases, nerve, muscle and bone disorders and adolescent health issues. The MCRI was formed when the Murdoch Institute and the Royal Children's Hospital Research Institute merged in January 2000, creating the largest children's health research institute in Australia with more than 1000 staff. The merger brought together international experts in human genetics and genomics, paediatrics and neonatology, public health, education and ethics. The many scientists, researchers, doctors, counsellors and support staff working at the MCRI are the institute's greatest assest. Their passion for children's health and the quality of their research has created an international reputation for the MCRI. A not-for-profit organisation, the MCRI depends on the support of individual donors, charitable trusts and corporate sponsors.
A purpose-built clinical trials area is now well established. We provide a non-threatening and family friendly environment to clincial trial participants in both inpatient and outpatient settings.
APPRU has dedicated clincial trial pharmacists who have extensive experience in Clinical Pharmacology.