The Alberta Aids to Daily Living Program also provides financial assistance for the purchase of medical equipment to low-income people with long-term physical disabilities or chronic or terminal illnesses. The costs of clinical drug trials are not among the extensive public disclosures now required by US federal legislation1 , the International Committee of Medical Journal Editors2 and others. Luigi Visani is the president and CEO of Exom Group Srl, a full-service Italian clinical research organisation (CRO) based in Milan and specialised in providing a wide range of clinical trial management services for the biotech, pharmaceutical and medical sectors. CROs prepare and ship clinical supplies for sites as needed, and track and ship additional supplies during the course of the study.
Olivier Cadiou is the Business Development Director of Synerlab Group, a European CDMO based in France and specialised in the development and contract manufacturing of pharmaceuticals, medical devices and food supplements. The number of participants in a clinical trial is a key driver of overall costs, as each patient enrolled involves a fee that the sponsor must pay to the hospital to cover tests and medical procedures. As device costs rise, and as policy makers demand more evidence on device-related treatments, the cost of medical device-based interventions must be documented along with their efficacy. Industry-sponsored CT scans have been used primarily to measure the efficacy and safety of medical devices.
The CRO may provide a medical monitor for the trial, but this is not always the case, as that role may also be played by pharmaceutical or biotech company personnel. Three other trials that did not use medical devices but were specifically designed to develop a clinical tool or evaluate a disease-specific patient-reported outcome instrument or rehabilitation assessment programme were excluded. Of the 18 medical device trials remaining for analysis, the most common device group was cardiology, with ten (56%) devices. In the medical device CTs, patients in the experimental arm always used the interventional device, while patients in the control arm could use similar devices from other companies, the interventional device or no device, depending on the trial protocol.