ObvioHealth creates new app for site-less clinical studies

CEO of ObvioHealth, Bryan Silverman, told us the app - ClaimIt - democratizes clinical studies, as there are no geographic barriers to patient recruitment. "No longer are you leaving people out because of reasons x,y, or z​," he said.

The ObvioHealth app does not restrict recruitment based on location since site-less studies can be created. "Data has shown that within a 12 minute plus drive your drop-off rate is like falling off a cliff," ​Silverman explained, "So, it becomes exponentially costly depending on the study."​

While studies may not require a site, patients can be contacted as frequently as needed in different ways. Silverman said, "I could have a one-on-one dialogue in virtual reality with consumers or patients." ​Most often it is through in-app dialogue, chat box, or questionnaires.

"It becomes more patient-relevant, it enables patient dialogues, it now becomes patient-centric. The patient or patient as consumer has a voice. Where before, they had no voice,"​ he added.

Patient dialogue can also be tracked, so that anything that may be considered an adverse event (AE) is sent to a health care provider.

"Normally an AE doesn’t get recorded until the subject goes back to the study site, and that could be a week or month out depending on the study,"​ Silverman explained."That's valuable data that is lost. With this platform you can report it real time when it happens."​

Mobile clinical study platforms, like ClaimIt, also enable adaptive study design: "The standard operating procedure is to let the study finish, even though we know it’s going to fail, and then is money lost. Here, as long as it’s written in the protocol and approved by the IRB, you can actually course correct things like dosage or your study population size,"​ said Silverman.

The platform also complies with GDPR (General Data Protection Regulation). "It gives them [patients] true capability to own that data, not only are they learning what we’re doing with that information."​

Additionally, Silverman said the app simplifies post-marketing surveillance. "People do not have the invasiveness of going to a study site. So you can communicate with people daily in regards to how they’re using the IP [intellectual property]​."

ObvioHealth also is adding a behavioral component to the ClaimIt platform to screen for possible patients that have a higher risk for protocol deviation.

Silverman said the behavioral component will enable companies to build an early business case for market access. "It can actually show you early positive behaviors around medication adherence, and it can show those early behaviors that then enables pharma to build a business case early, and allows for them to get their new drug into their formulary" ​he added.

ClaimIt is only available on iOS or Android Smartphones currently.