Clinical Trials - Innovation needed

We all know that digitalization within healthcare is a harsh mistress. So a lot of health innovators think let's start with clinical trials where stakeholders, customers and patients are similar to the broader healthcare sector. If the smart solution works in a clinical trial, then it's applicable in the broader healthcare sector.

Well, if it was so easy, why hasn't anyone done it already? Join the health innovators at SUND Hub and the Health 2.0. CPH Chapter for a morning session about how we can do innovation within clinical trial testing of pharmaceuticals products and medical equipment.

Program:

1. Clinical trial - A start-up perspective (08.15-08.30 h)
   Cortrium (https://cortrium.com/) started back in 2015 with testing of their Vital Sign monitor in clinical trials with healthy volunteers and then moved on to patients at hospitals in Denmark and Germany in 2016 and 2017.

Jacob Eric Nielsen will present the regulatory framework and the challenges the company faced with the Danish and German health authorities and ethical committees when applying for a test of a novel sensor device.

2. Clinical trial innovation (08.30-09.00 h)
   Attendants are discussing possible innovative solutions in regard to data management, patient recruitment, retention of learned lessons, etc. Also, strategies for introducing connected health solutions and novel sensor devices will be discussed.

3. Presentation of innovative solutions (09.00-09.15 h)
   Group presentation in the plenum.

4. Breakfast at SUND Hub (09.15-10.15 h)
   Everybody is invited to stay for coffee and breakfast until 10.15 h.

Why innovation in clinical trials make sense?
Clinical trials are labour intensive and time-consuming. Do you think the digital innovation has started in smaller scales with clinical trial testing? No, most trials are still done with an offline registration of patients and data management in spreadsheets. Hence, there is a basis for innovation in the way we conduct clinical trials.

But why? It's a billion dollar industry. Big pharma is involved and wants their products tested for market-entry as quick as possible. Currently, approximately 100.000 clinical trials are ongoing worldwide with an estimated total market value of 64B$. And still, data management and patient recruitment are like in the old days before the launch of the Internet.

The only thing that has happened over the past 10-15 years is the outsourcing of clinical trial management to so-called Contract Research Organisations (CRO). However, the conducting of trials and the regulatory framework have remained unaffected. Hence, no unilateral patient data management system has been established as accepted standard, medical doctor use data storage on PCs, and recruitment of patients starts over and over again from zero on paper.