The traditionally conducted clinical trial model requires increasing amounts of time, cost, and resources for both sponsors and sites. In fact, fewer than 10% of clinical trials are completed on time due to poor patient recruitment, retention and protracted budget negotiations. And since 2008 per-patient, clinical trial costs in the US have risen an average of 70% across all development phases.
In March 2015, however, BLOOMBERG BUSINESS
reported “Stanford University researchers 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, less than 24 hours after the iPhone tool was introduced. ‘To get 10,000 people enrolled in a medical study normally, it would take a year and 50 medical centers around the country’ said Alan Yeung, medical director of Stanford Cardiovascular Health. ‘That’s the power of the phone.”‘
At Scanadu, data collection and clinical studies are key to the development and deployment of our medical devices, and we’re fully aware of the kind of scale and speed and power we’re talking about here. And as a startup developing the next generation of medical devices for consumers, we had to innovate the clinical study process, while bucking the traditional assumptions of how a clinical study should operate.
In May 2013, we launched the most successful crowdfunding campaign for a medical device on Indiegogo –The Scanadu Scout™ for investigational use – because we wanted to leverage this campaign and its platform to put together our FDA study. More than 8,000 people backed the campaign.
More than 8,500 people from 72 countries backed the INDIEGOGO CAMPAIGN.
We partnered with Scripps Translational Science Institute (STSI) and, after cautious preparation, officially launched the SCOUT study for the investigational medical device in early 2015.
STSI is now conducting a completely mobile-based trial evaluating the impact of the Scanadu Scout, the first comprehensive, handheld, wireless device designed for personal use, measuring blood pressure, core body temperature, oxygen saturation and heart rate. The aim of the study is to understand how the device modifies 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 (eICF ) 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 has enrolled in our study – or is currently using Research Kit in a study such as GlucoSuccess, Asthma Health, Parkinson mPower, or MyHeart Counts – will agree that using an eICF presents many opportunities and advantages for both sponsors and participants. With this new system we now have the ability to enhance a participant’s understanding of the trial, to inform about changes to the study’s protocol, to allow for subjects to consent from remote locations with the use of an electronic signature, and make it easier (with appropriate pre-planning) to enroll non-English speaking subjects.
Using a HIPAA-compliant platform for the ICF process has eliminated major problems found on these forms including missing or incorrect signatures and dates or lack of verification that the subject received a copy. However, using this type of platform for eICFs did pose some hurdles. While this particular digital signature platform was user-friendly for the most part, not knowing all of the intricacies of sending the documents led to some confusion for some recipients. This contributed to a pause in enrollment for a few days and resending some ICFs to potential subjects. No system is completely flawless, and during enrollment, we found technical glitches that caused a change in expiration dates on the documents.
While this did not cause any compliance-related issues, the team had to manually close out any eICF document that was not signed by the enrollment end date. Also, because we used a platform that was not specifically designed for eICFs, sending out a revised version proved to be complicated. These challenges led to unanticipated increases to clinical resources/budget in order to manage and rectify the situation.
The online survey tool used in the study was seamlessly integrated into the process. Creation and distribution of surveys has proved effortless. Data is stored on a secure system, which is HIPAA-compliant and only accessible to the clinical team. Data collected from subjects also has audit trails. The data can be downloaded and analyzed in real time. This platform has been very useful in simplifying data collection and subject engagement.
The SCOUT study has an unprecedented enrollment rate for a medical device, and while there were challenges, this success is thanks to the transparency of the process, the incredible engagement from the participants, and the full use of what technology is allowing us to do today.
Access to information, knowledge and rapid development of technologies has an unparalleled impact on the progress of science. We imagine a world in which even more people participate in clinical trials like this one to further our understanding of our health and to improve life for the next generation.
Scanadu is based in San Diego, California. Follow them on the Scanadu blog, where this post first appeared.