Poster Presentation Clinical Oncology Society of Australia Annual Scientific Meeting 2024

Collaborative, patient guided approach to a first-in-human study for advanced cancer (#298)

Christine Cockburn 1 , William Evans 2 , Kylie Shackleton 2 , David Thomas 3 , Malaka Ameratunga 4 5 , Narelle McPhee 6 , Annette Ervin-Haynes 7 , Amel Sadou-Dubourgnoux 8 , Pauline Darcel 8 , Ana Rubio-Jareno 9 , Maryann Rakopoulos 10 , Francis Hinds 10
  1. Rare Cancers Australia Ltd, Bowral, NSW, Australia
  2. Alfred TrialHub, Melbourne, Vic, Australia
  3. Omico, Kensington, New South Wales, Australia
  4. Department of Medical Oncology, Alfred Health, Melbourne, Victoria, Australia
  5. School of Translational Medicine, Monash University, Melbourne, Victoria, Australia
  6. Bendigo Health, Bendigo, Victoria, Australia
  7. Servier Pharmaceuticals, Boston, MA, United States
  8. Institut de Recherche et Développement Servier, Paris-Saclay, France
  9. Les Laboratories Servier, Madrid, Spain
  10. Servier Laboratories, Burnley, Vic, Australia

Aims  

Early-phase clinical trials are often the only treatment option for rare and hard-to-treat cancers. Despite this importance, regional and remote patients face barriers to equitable access in studies limited to metropolitan hospitals.

We aim to highlight how a collaboration, guided by lived patient experiences, creates opportunities for innovative trial design and addresses non-metropolitan participation barriers.   A sponsor-initiated, first-in-human and molecular-driven study provided the opportunity to apply the patient-centric decentralised trial (DCT) model.

 

Methods

At study conception, factors limiting regional trial participation were identified between patient advocacy groups and an international sponsor. The collaboration was expanded to Australian metropolitan and regional health services, and research institutions to formulate the final study design. Adaptation of the Teletrial model was chosen due to its risk mitigation approach. The regulatory-approved DCT model required considerable flexibility to conventional study processes and protocol design.  

 

Results

The final DCT model supported seamless movement of study care between metropolitan primary and satellite sites for in-person visits. A primary site was activated to receive regional patients for the first treatment cycles. The satellite site underwent usual regulatory approval and contract negotiations before being placed on hold for all study activities until an eligible participant is identified.

Patient barriers addressed through the collaboration included continuity of trusted care with local healthcare providers, safety concerns, travel burdens and access to informative genomic screening.

Additional benefits: broad screening to help recruitment, rapid activation of new satellite sites, and regional early-phase trial access for sites with limited capacity.

 

Conclusions

This unique collaboration, unified by a patient-centric vision, is an example of a successful, innovative approach to a first-in-human study. By increasing access to early phase trials closer to home, benefits are achieved for the sponsor, primary and satellite sites, and the regional community.