Oral Presentation Clinical Oncology Society of Australia Annual Scientific Meeting 2021

Teletrial model (TTM) as a new paradigm of trial conduct: assessing the impact on equity of access, accrual, retention, and safety (#151)

Marliese Alexander 1 2 , Samuel Harris 3 , Craig Underhill 4 , Javier Torres 5 , Sharad Sharma 6 , Jennifer Rogers 1 , Nora Lee 1 , Ben Solomon 1 2 , Kate Burbury 1 2
  1. Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia
  2. The University of Melbourne, Parkville, Victoria, Australia
  3. Bendigo Health, Bendigo, Victoria, Australia
  4. Border Medical Oncology, Albury , New South Wales, Australia
  5. Goulburn Valley Health, Shepparton, Victoria, Australia
  6. Ballarat Health Services, Ballarat , Victoria, Australia

Aims: To assess the Teletrial model (TTM) innovative trial strategy in an Australian multi-centre phase III clinical trial.

Methods: The TARGET—TP Trial (risk-targeted thromboprophylaxis for patients receiving anticancer therapy, ACTRN12618000811202), utilised TTM for conduct. The primary site (PS), a dedicated cancer centre, connected with 4 regional/rural (RR) satellite sites (SS). Trial operation and governance managed with site specific Supervision Plans, considered site capabilities and scope. Regular trial oversight meetings ensured connectivity, open communication and shared roles, responsibilities and accountability across PS and SS. Independent audit by contract research organisation assessed trial conduct against applicable standards. Trial, sponsored by Peter MacCallum Cancer Centre and Victorian Cancer Agency, accrued patients between June 2018 and July 2021.

Results: At accrual completion , 152/328 (46%) were RR recruited at SS with sustained rapid recruitment ~10/month and low drop-out despite high RR participation with significant distance from participant home to trial sites. SS 119-325km from PS; participants on average 52km from SS and 235km from PS. At abstract submission, drop-out rates: 3% month 1, 10% month 3 and 17% month 6 (37/42, 88% due to death); only 6 withdrawals. Recruitment rates differed across sites for cancer types, conferring broader representation, but no major differences in characteristics (age/sex/cancer stage/therapy). No major trial violations with regards to TTM.

Conclusions: In Australia >30% patients with cancer reside in RR areas and <5% participate on clinical trials. With TTM, 46% RR participation exceeded state-wide RR recruitment for cancer trials. High recruitment and retention were achieved by reducing trial participation burden and professional connectivity for high level care. With safety and efficacy of trial conduct including feasibility, socially and economically, this proof of concept will enable routine TTM implementation, with greater access to trials for all patients with cancer including rare cancers, and metro-RR clinical and research opportunities.