ARCS Australia calls for key changes to strengthen the clinical trial sector

Medical News: The COVID-19 pandemic has been a transformational disruption for all aspects of society, including the healthcare sector. The clinical trials sector has adapted quickly to ensure the successful continuation and management of clinical trials during the acute phase of the pandemic.

Under the leadership of ARCS Australia, a group of Contract Research Organisations (CROs) are calling on the federal government to improve policies and processes around national coordination of clinical trials in Australia.

Dr Shanny Dyer, CEO of ARCS Australia, stated “The position statement sets out what needs to be done to remove the most significant barriers to how clinical trials are delivered in Australia.”

ARCS position statement key points

1. Australia remains open for establishing new clinical trials and supporting ongoing clinical trials, which save lives, improves the health and quality of life of participants.

• To enable these health and economic opportunities, there is a need for a national approach to identify clinical trial sites and site status which assists all stakeholders to attract and implement clinical trials in Australia in a timely and cost-effective manner for the wellbeing all participants.

2. Embedding key virtual processes and decentralised trials is essential to improve the conduct of clinical trials in Australia.

• The development of national standards which facilitates embedding patient centric decentralised research practices in Australia.
• The development of national standards for e-signatures, telehealth, e-consent and remote montoring, independent of software solutions and based on international regulations

3. Eliminating redundancy to improve start-up times and competitiveness internationally.

• Improved start-up times for trials will ensure that, irrespective of times of crisis, we can be more responsive to the needs of patients and their access to clinical trials.

“ARCS Australia has supported the CRO sector by providing a platform for open and frank dialogue to identify common issues. ARCS will continue to provide high quality accredited training on international standards and GCP as well as specific training on all aspects of conducting clinical trials,” concluded Dr Dyer.

Benefit of clinical trials to healthcare, patients and economy

Healthcare

Clinical trials remain critical to delivering innovative drugs, vaccines, medical devices and diagnostics, and therapies to Australian consumers and patients in a safe and regulated manner. Given the predicted impact of COVID-19 on the health system and services, CROs and others in the sector are working with doctors, research nurses and clinical trial sites to address disruption of normal research activities.

Participants

Trial participants gain early access to innovative new medicines and therapeutic goods. Clinical trials help improve the standard of care through the uptake of evidence into practice. At all times, the safety and continuity of care of clinical trial participants is the key concern of all professionals working with patients.

Economy

Clinical trials are also an important contributor to the Australian economy contributing to the GDP, attracting overseas investment, and supporting skills development and retention. The international clinical trials sector is predicted to grow significantly over the next decade and it is important for Australia to have policies and systems in place to capitalise on this growth.