134P CT homecare an academic coordination platform for decentralized clinical trials

Background: Few sponsors offer decentralization solutions, and when they do, they are heterogeneous and time-consuming.CT HOMECARE is an academic coordination platform that organize decentralized clinical trial visits at patients' homes in a secure manner and in accordance with protocol requirements.Methods: This platform relies on two partners: A nursing service provider that employs experienced staff trained in clinical research, emergency procedures, and care, deployed throughout the country.The other one is a company who provides an electronic medical record used by home nurses accessible via a computer, tablet, or smartphone in online or offline mode.Staff are trained by CThomecare and delegated by the principal investigator of the trial.Access to data collected at home is available in real time.Results: Thanks to this system, CTHOMECARE is able to organize home visits to carry out "simple" follow-up consultations involving pharmacokinetic sampling, vital sign monitoring, biological assessments, as well as protocol visits involving the administration of the treatment under study, regardless of its form.CThomecare is now operational with three clinical research protocols underway, including a first-in-human study allowing 4 visits at home during the active treatment phase, including the DLT period.In the FIH study, vitals, PK sample and biological sample were collected and processed at patient's home.5 patients benefited from the program since its launch in December 2024 during the escalation phase.The number of kilometres avoided per patient ranges from 100 to 2,800 km.In another study, for 11 patients to date, treatment has been delivered at patient's home avoiding the patient to come back at hospital.Vitals and satisfaction has been evaluated.Each patient avoid 2 visits at hospital.The last study already included to date 4 patients, avoiding one visit per patient at hospital for a PK sample.Conclusions: 20 patients, representing 50 home visits benefited of this organization.The implementation of decentralization represents a major step forward for patients in terms of access to innovation and quality of life.By reducing the constraints associated with research protocols, it also helps to patient's retention in trials.Legal entity responsible for the study: Oncopole Claudius Regaud.