Device trials can be the key to understanding the total cost of treatments in which devices are an important component. As an innovator of a new medical device, you must decide what role you want to play in the lifecycle of your device (from concept to commercialisation). The estimates assess a range of what a contract research organisation might charge for conducting the study and do not include the sponsor's costs for study design, contract oversight or medication. We have seen that new business models and advanced technologies can help sponsors conduct trials of connected medical devices more cheaply and quickly.
The amount of money to be paid by the sponsor to the clinical centres where patients are treated to cover medical procedures and tests varies between study types, but in the US, the medical condition treated and related therapeutic areas were defined in IQVIA's CostPro Mid-Level tool based on a subset of the International Classification of Diseases version 9.A CRO is a clinical trial management company that handles all or several of the tasks involved in a clinical study, such as regulatory affairs, site selection, on-site monitoring, data management, biostatistics and medical writing, among others. It should be noted that the costs of drug trials, including CRO and regulatory affairs, are an order of magnitude higher than for connected medical devices. For connected medical device studies on pain, cannabis and chronic diseases, most of the source data can be collected by the CRC with direct patient interviews. CROs prepare and ship clinical supplies for sites as needed, tracking and shipping additional supplies during the course of the study.
The CRO may provide a medical monitor for the trial, but this is not always the case, as that function may also be performed by pharmaceutical or biotech company staff. For most medical device companies, clinical trials are the most important area of operational R&D expenditure. Clinical trial cost factors - the fourth in a series of blogs on clinical trials for medical device innovators. 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 medical tests and procedures.
However, unlike the validation of a connected medical device for a well-defined intended use, Litmus Health focuses on clinical data science for health-related quality of life. A set of variables describes the basic characteristics of clinical trials, such as the medical condition treated, the number of patients tested, the number of enrollees in the trial, and the duration of treatment. RWD and RWE can be used in 4 ways to improve the design of medical device clinical trials when there is a predicate device already being used to treat patients.