Combat-caused PTSD is often associated with other psychiatric disorders, including depression, anxiety, mood disorders and substance abuse disorders ( 22 ). More specifically, 57–62% of Croatian Balkan war veterans diagnosed with PTSD also met co-morbid diagnoses criteria ( 44 ), with the most common being depression (Muck-Seller et al ., 2003), alcohol, drug abuse, phobias, panic disorders and psychosomatic and psychotic disorders ( 45 ). In terms of PTSD-associated psychotic symptomatology, between 30 and 40% of combat-related PTSD subjects may go on to develop psychotic symptomatology ( 45 , 46 ).
The Clinical Trials Unit (CTU) consists of a team of specialist research nurses and scientists who provide our research partners with first-class conduct, management and coordination of multi-centre national and international clinical research trials.
Benefits of our Clinical Trials
These phase I-IV clinical trials benefit the community through enhanced medical knowledge about the place and value of new treatments. Medical specialists can gain experience with new therapies and trial participants can take part in study protocols of new and potentially improved therapies. The result is enhanced quality of care and treatment not available as standard care.
Information for the medical community: Conducting a trial with the CTU
The CTU team manages all documentation of clinical trials including paper and computer-based case record forms. We also assist with study design, regulatory affairs, database maintenance, and participant recruitment. The CTU takes responsibility for liaising between the Gallipoli Medical Research Institute, the Therapeutic Goods Administration (TGA) and local ethics committees. We provide our research partners with first-class conduct, management and coordination of multi-centre national and international clinical research trials.
Information for potential trial participants
All CTU trials are run under strict conditions. Our Clinical Trial Coordinators ensure all participants are treated with the utmost care, while our Data Manager oversees the meticulous data entry for each of participant visit. In addition, trial monitors from each company involved in our trials visit us regularly and double check every single number that we enter in order to ensure the trial is run correctly.
Trial participants will never be ‘out of pocket’ health wise for participating in a trial; every patient gets the standard of care treatment – alone or combined with a new treatment. We work with our patients to make sure that any new treatments truly live up to their claims. In this way, we can together improve future health outcomes for all Australians and the wider global community.