Local knowledge combined with Australia’s favorable conditions keep trial on track and on time.
Early phase clinical trials are the first-line research studies in drug development and assess therapies for safety, dosage levels and side effects. These studies form the basis for all further research on therapy, so they must be conducted to very high standards whether the trial involves healthy volunteers or patients with a specific disease such as cancer. Fully-equipped early phase specialty research centers conduct these studies in strict accordance with the protocol and provide very close monitoring of the trial participants.
George Clinical offers a full range of services for Phase I-II clinical trials including study design, protocol development, medical oversight from practicing clinicians, site monitoring, regulatory affairs, database development, and statistics and data management. Our home base of Australia is well-equipped for early phase trials with a network of around 200 beds ready for Phase I-II trials in dedicated units across the country. These centers can conduct trials from small first-in-human (FIH) to complex multi-center Phase I, II patient trials. George Clinical has strong relationships with these sites throughout Australia and New Zealand.
In conjunction with a Chinese biotech company, George Clinical recently initiated an early phase oncology study being conducted in patients with advanced cancers that have not responded to commercially available treatments and who have no other current treatment options. This study addresses the critical need to get a new drug to market that may provide these patients with a treatment option—and hope. With a very short timeline for completion of this early phase trial, the sponsor elected to conduct this trial in Australia. Benefits of this strategy include Australia’s streamlined Clinical Trial Notification (CTN) system, the comparatively lesser impact of the COVID-19 pandemic and the country’s R&D Tax Incentive.
George Clinical’s goal going forward is to continue to provide this study with the support it needs to be successfully completed within the sponsor’s timeline and to ensure the safety and attention to all participating patients whose important contribution to this study will help provide better cancer treatments for all in the future.
George Clinical was selected by the sponsor as the best fit for this trial with our offering of end-to-end CRO services, our partnerships with key oncology Scientific Leaders, and our deep and current knowledge of the oncology landscape in Australia and New Zealand.
CHALLENGES
Despite a large number of ongoing competing trials in Australia, timeliness of trial conduct was critical to the sponsor’s development plans. They needed assurance that the trial design would meet requirements without sacrificing quality or safety. Site selection was important with respect to both the early phase ability of the site and the best opportunity for rapid and efficient recruitment. In addition, it was necessary for local physicians to have buy-in on the study for recruiting optimum patients most likely to complete the study and preserve retention in the trial.
Complete case study available via download below.
