Rural, Regional and Remote Clinical Trial Enabling Program

The program aim will be achieved through the delivery of five interdependent key projects:

1. Deliver clinical trials directly to the community: develop decentralised clinical trials capacity and capability
2. Involve communities in clinical trials: clinical trial awareness, engagement, recruitment, and retention
3. Conduct trials to international best practice standard: professionalise rural, regional, and remote clinical trial services
4. Support and develop the local workforce: deliver locally through rural, regional, and remote clinical trial support units
5. Governance and project coordination.

In rural, regional, and remote settings, populations suffer worse health outcomes than in metropolitan areas, with shorter life expectancies. People in these areas also lack access to clinical trials and new products and therapies.

Trials addressing the health needs of rural, regional, and remote populations are rare, resulting in a lack of evidence on how to improve practice in these settings. Barriers to research in regional areas  include geographical isolation, and lack of workforce experience, skills, and capacity. These can make trials in these areas unattractive to sponsors, which results in inequality of access to trials and innovation.

Clinical trials provide the most robust evidence to change clinical practice. Clinical trial involvement by patients, clinicians, and healthcare organisations offers early access to new treatments, skills, and medical technology; in turn generating significant economic, medical, and scientific benefits to the rural, regional, and remote areas of NSW and the ACT.

Health care environments active in research and clinical trials have better outcomes, due to many factors including better training and retention of staff. Australia has a strong track record of leadership in clinical trials and NSW is established as a key player.

The following principles will guide the program of work:

1. CORE values of NSW Health: Collaboration, Openness, Respect and Empowerment
2. Participant-centred: We will engage patients, carers and the wider public as partners in all our activity: to improve research quality and relevance, to ensure patients have an optimal participation experience in clinical trials; and that conditions of greatest importance to patients are well represented in the portfolio.
3. Inclusive partnership and collaboration: The project will be collective with collaborative working as key to our shared success. We will have strong relationships with our partners and be responsive to their feedback. Our partners will be:
   a. healthcare providers: to streamline and performance manage network support for trials, ensure that trial conduct is efficient, and ensure that support costs are covered; minimise bureaucracy and find pragmatic solutions to problems; integrate health research and patient care, and promote a strong research culture.
   b. clinical trialists and academics who will drive methods and innovation in delivery
   c. medical technology, pharmaceutical and eHealth industries to meet their trial needs.
   d. counterparts in metropolitan areas, other states and networks.
4. Effectiveness and efficiency: We will provide a consistently reliable and excellent service to researchers in all studies, in all parts of NSW, agnostic to discipline/type of trial. We will monitor progress and delivery and adapt as needed.
5. Development: We will continue to learn and develop the best approaches to delivery of rural, regional, and remote trials. We will continuously review and improve all our structures and systems to ensure the quality, speed, and cost-effectiveness of clinical research. We aim to be a world leader in methodology and delivery of rural, regional, and remote trials.

The Rural, Regional and Remote clinical trial enabling program is overseen by a robust governance structure.

The Executive Committee

The Executive Committee provides risk-based leadership and decision making to support the delivery of the program in scope, on time, and budget. The Executive Committee members are appointed for a minimum of two years, reviewed every two years, and renewed up to a maximum of five years.

The Advisory Group

The Advisory Group provide expert advice to support the operational implementation of the program.  The Advisory Group members are appointed for a minimum of two years, reviewed every two years, and renewed up to a maximum of five years.

All enquiries related to the Executive Committee, the Advisory Group or other enquiries should be directed to MOH-RRR-CTEP@health.nsw.gov.au