Utilizing key therapeutic knowledge leader networks as championed by George Clinical has again shown its effectiveness in boosting recruitment; this time for a Phase 1 renal patient trial.
It is widely understood that the recruitment of patients into a Phase 1 trial can be fraught with difficulty.
This difficulty arises from:
- A lack of established clinical benefit for the patient;
- The fact that patients may be experiencing personal crisis due to ill health;
- The burden of additional clinical visits, including overnight stays; and,
- Patients not being open to participation in a trial where there is no evidence supporting the efficacy of the intervention.
As such, setting up a phase 1 trial for a compound that could have a positive impact on chronic kidney disease is prone to complexity that may be insurmountable unless addressed with innovative solutions that focus on bolstering recruitment by involving key scientific leader networks, with execution conducted by operational experts.
For this phase 1 patient trial, George Clinical leveraged their in-house scientific leaders, internationally renowned renal physician-researchers, to engage a number of their physician colleagues from leading Australian hospitals as referral sites. The physicians were open to participating in Phase 1 renal trial due to the high professional regard in which they hold their
George Institute peers. Once these referral sites were established, George Clinical oversaw the operational, governance and regulatory aspects of the trial.
George Clinical has implemented different referral models for phase 1 trials. In the renal trial case, the sites were only referring patients and not undertaking trial related activities, so George Clinical facilitated the RGO approval process for the sites before the referral process commenced. George Clinical also facilitated the Medicines Australia CTRA processes and
ensured that all parties were protected via indemnification.
In a separate example George Clinical set up referral sites that both consented and screened the patients before sending them to a phase 1 unit for the initial dosing. Patients were followed-up within the phase 1 unit before being returned to their referring site for long term follow-up activities. In this case, the referral sites needed to set-up as fully operational clinical trial sites.
In both cases, George Clinical used its operational expertise, agility, and local knowledge to negotiate the operational complexities of running multi-centre referral study.
George Clinical is a leading full-service CRO in the Asia-Pacific. In addition to its ability to provide world-class operational services, its capacity to leverage scientific leadership, their networks along with comprehensive regulatory expertise, allows George Clinical to help sponsors navigate the most complex multi-centre trials throughout the region and globally.
About George Clinical
George Clinical is a leading clinical research organisation in the Asia-Pacific region with over 260 staff operating in 15 countires. George Clinical provides a full range of trial management services to pharmaceutical and biotech customers, for both registration and post marketing trials. Our organization, The George Institute, is a leader in chronic disease research with a global network of experts. George Clinical combines this scientific and clinical leadership from the Institute with world class trial delivery capability to create a distinctive service. Our internationally recognized scientific leadership allows George Clinical to provide excellence from design to delivery. Gain access to Asia.