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Disruptive Real World Data & Real World Evidence Internet of Things platform for faster and more accurate clinical studies

Periodic Reporting for period 1 - HumanITcare (Disruptive Real World Data & Real World Evidence Internet of Things platform for faster and more accurate clinical studies)

Reporting period: 2019-12-01 to 2020-05-31

Clinical trials (CT) are crucial to improving drug development and safe lives worldwide. However, it takes an average of 8 years and $100m to complete and is a critical component in drug development (total cost of $2.6 billion and a time to market of 12 years). Relevant to this proposal, some of the reasons that cause CTs to have high costs and lengthy time frames for Study Sponsors are ineffective monitoring, weak quality control measures, poor data management, and lack of reporting tools. Among all phases, on average, these challenges amount to approximately 45-50% of the costs. Due to these high costs and long durations, ~12% of drugs are not developed. Furthermore, traditional methods for evaluating the evolution of the symptoms produce data that is episodic, subjective, and scarce, meaning that patients, clinicians, and other stakeholders do not have needed evidence to make real-world decisions. Also, the obligation for patients to be physically in the hospital/clinic to perform the evaluations supposes an inconvenience and is a time-consuming activity for both parts estimated at 12 hours per week per patient. This ineffective monitoring, weak quality control measures, poor data management, and lack of reporting tools causes clinical trials (CTs) to be lengthy and costly processes.

Benefits society by saving time to doctors from administrative work and thus, being able to spend more time attending patients, increasing the quality of the treatment and diagnostic; also, it prevents relapses of chronic patients; and, helps to research drugs in real environments (RWD).

Our ambition is to be the best company for remotely monitoring the health of patients or the overall population using their own devices or disease-specific devices. With the grant and the coaching of the SME phase I, we intend to perform 1) market study; 2) regulatory analysis; 3) business plan. As part of our ambition, in 4 years, we will work towards entering the clinical Value-Based Healthcare market too (€2.4bn 30% job increase) with the aim to improve patients’ health outcomes by providing a better follow-up.
The work performed since the beginning has been focusing on the feasibility study, for 6 months we had been working in the business plan that includes:
1) description of the market analysis
2) the commercialization plan
3) regulatory roadmap
4) and specific business plan for Value-Based Health Care.
subjective and scarce, meaning that patients, clinicians, and other stakeholders do not have needed evidence to make real-world decisions. Also, the obligation for patients to be physically in the hospital/clinic to perform the evaluations supposes an inconvenience and is a time-consuming activity for both parts estimated at 12 hours per week per patient. This ineffective monitoring, weak quality control measures, poor data management, and lack of reporting tools causes clinical trials (CTs) to be lengthy and costly processes.

Our action to solve this problem is an IoT platform that provides RWD & RWE, which allows a passive 24/7 remote monitoring of patient’s symptoms in CTs. The platform is composed of:

- a smartphone app, through which patients’ novel real-life data and ePRO are collected from various devices (smartphone, sensors or wearables)

- a web portal, through which medical professionals can set-up the study’s settings and consult patients’ real-life data after being turned into biomedical and clinical insights using deep learning techniques.

The ambition of the HumanITcare platform is to be the best company for remotely monitoring the health of patients or the overall population using their own devices or disease-specific devices. With the grant and the coaching of the SME phase I, we have performed 1) a market study; 2) a commercialization strategy; 3) a regulatory analysis, and 4) a Value-Based Healthcare business plan.

After our feasibility analysis, our results have shown that the best European country market to start expanding our company it would be Germany due to the high performance of clinical trials (CTs) and its high commitment to R&D projects. Regarding the implementation plan, we have concluded that the best option is to start with a market segmentation within our target strategic countries, in which we will launch our marketing campaign focused mainly on specialized congresses as well as through social media, and that our pricing plan should be based on a subscription model depending on the amount of data to be processed. Then, our regulatory roadmap includes getting the CE mark and the Medical Device Regulation (MDR) this year (2020), in which we have already started working in order to be classified as a medical device. Finally, we have carried out a new business plan including the Value-Based Health Care (VBHC) model in order to reach hospitals and improve patients’ health outcomes by providing a better follow-up, which is shown to be a promising market for the company.