Medical Research: Rebuilt, Retooled and Rebooted An early stage mobile medical device company developing a human-centered suite of consumer products using science and technology to empower everyday people to monitor and better understand their own health—anytime, anywhere.
The traditionally conducted clinical trial models need increasing amount of time, cost, and resources for both sponsors and sites. Only fewer than 10% of clinical trials are completed on time due to poor patient recruitment and budget negotiations. Since 2008 per-patient, clinical trial costs in the US has raised by an average of 70% across all growth phases.
In March 2015, BLOOMBERG BUSINESS reported that Stanford University scientists were stunned when they awoke Tuesday 10 March to find that 11,000 people had signed up for a cardiovascular study using Apple Inc.’s ResearchKit within less than 24 hours, after the iPhone tool was introduced.
Fact says that to get 10,000 people enrolled in a medical study normally would take a year and 50 medical centers around the country……That’s the power of the smartphone…..smart technology!
At Scanadu, data collection and clinical studies are key to the development and deployment of medical devices. And as a startup developing the next generation of medical devices for consumers, they had to innovate the clinical study process, while defying the traditional assumptions related to a clinical study.
In May 2013, they initiated the most successful crowd-funding campaign for a medical device on Indiegogo , because they wanted to standardize this campaign and its platform to put together their FDA study. Over 8,000 people backed the campaign.
They associated with Scripps Translational Science Institute (STSI) and, after cautious preparation, officially launched the SCOUT study for the investigatory medical device in early 2015.
STSI is now conducting a completely mobile-based trial analyzing the impact of the Scanadu Scout, the first comprehensive, handhold, wireless device designed for personal use, measuring core body temperature, blood pressure, oxygen saturation and heart rate. The study aims to understand how the device improves health behaviors in participants and to evaluate the ease of use and acceptance of the technology.
All platforms were HIPAA-compliant, all content was Institutional Review Board (IRB) approved and an electronic informed consent form was used. More than 75% of all backers based in the US signed up for the study, and in the latest survey more than 90% of them expressed that they would be willing to participate in such a study again.
Anyone who enrolled in their study – or is currently using Research Kit in a study such as GlucoSuccess, Asthma Health, Parkinson mPower, or MyHeart Counts – will definitely agree that using an eICF presents many opportunities and advantages for both sponsors and participants.
Using a HIPAA-compliant platform for the ICF process has eliminated major problems including missing or incorrect signatures and dates or lack of verifications. However, using this type of platform for eICFs did have some hurdles. While this particular digital signature platform was user-friendly for the most part, not knowing all of the details of sending the documents led to some confusion for some recipients. This led to a pause in enrollment for a few days and resending some ICFs to potential subjects. No system is totally flawless and during enrollment there were technical glitches that caused a change in expiration dates on the documents.
The SCOUT study has an unequaled enrollment rate for a medical device, and while there were challenges, this success is due to the transparency of the process, the incredible engagement from the participants, and the full use of today’s technology .
Access to information, knowledge and rapid development of technologies has an unequaled impact on the progress of science. If many people participate in clinical research trials like this then mode development can be made in the field of Clinical Researches.