Clinical trials play a vital role in quality improvement, and the Commission wanted to understand their full potential to influence health outcomes as well as their economic impact. In 2016, the Commission engaged the Australian Clinical Trials Alliance, in partnership with Quantium Health Outcomes, to evaluate the overall health and economic impact of investigator-initiated clinical trials conducted by networks.
Governments are increasingly looking to foster greater coordination and integration between safety and quality and research activities to build self-improving models of health care. As a result, there is a growing need to determine appropriate strategies to support high-quality public-good clinical trials as an integral part of the healthcare quality, safety and value agendas in Australia.
This project is intended to support evidence-based decision-making and is closely linked to the Commission’s broader strategic priorities.
If the results of the 25 trials included in the study are implemented in 65% of the eligible Australian patient population for one year:
In addition, the report found that:
Clinical trials are studies that explore the impact of new or existing approaches to health care. They generate evidence to inform best-practice ways of providing care or treatment to patients. The outcomes of clinical trials can provide evidence that leads to the adoption or continuation of effective treatment and care, or the cessation of ineffective interventions. Given the valuable insights that clinical trials offer, they are an important component of a ‘self-improving healthcare system’ (see Figure 1).
A self-improving healthcare system
There are a number of different types of clinical trials. Trials can be initiated by various groups of people, and can occur in different ‘phases’. The phase refers to the point in the research process, and ranges from ‘early phase’, which tests the safety of an intervention in small groups, to ‘late phase’ trials that monitor long-term effects in the whole population once an intervention is implemented. Their findings can vary, from no difference between compared interventions, to highly significant differences that lead to changes in clinical practice. Late-phase investigator-initiated trials can be complex in logistics and methods, and are thus often conducted in networks.
Networks are made up of a geographically dispersed and multidisciplinary community of experts, which have formed to overcome some of the challenges of designing and conducting these trials successfully. Common among all networks is the involvement of multiple healthcare facilities and practising clinicians. Networks add value by ensuring that highly relevant research questions are generated and that the correct methodology is used to answer research questions. They provide efficiency through established trial infrastructure and site-based partnerships that provide access to patients and specialised trial coordination expertise, and ensure capacity through the training and career development of trial experts.