Virtual clinical trials are here. Will they work? Todd Johnson of Halloran Consulting Group gives his insight as a participant of a virtual clinical trial.
I am currently participating in a clinical trial. I have neither seen a physician nor traveled to a site for a procedure. During my first 15 days of trial participation, my samples have been sent 43 times – and I never once had to leave my house for it.
I am enrolled in the Apple Heart Study – a clinical trial run by Apple in collaboration with Stanford Medicine to assess if data from my Apple Watch can be used to identify irregular heart rhythms.
Eligible participants can literally register in the Apple Heart Study between turns at Trivia Crack. There was not only a legitimate 10 page/screen informed consent document that I needed to read (and check for required elements), but there was also a signature page (along with HIPAA authorization) that I signed with my finger. I then quickly completed my demographic information along with several cardiovascular medical history questions. That is it. I am now participating in the study, and my heart rhythm data is sent several times daily (depending how active I am). I can track all of this through the Heart Study app and can withdraw at any time with a tap of my fingertip.
This is patient-centricity at its finest.
Change is upon us
Much has changed in the past 25 years – mobile phones have replaced landlines and payphones, the weighty encyclopedia has fortunately been replaced by Google, and the cloud has relegated the floppy disk to a mere icon in a software program. Having worked in the pharmaceutical industry for over twenty years (and a healthy volunteer in my college days), I can unequivocally say that change is indeed upon us.
In an industry that has not necessarily been recognized for being agile, we are beginning to see some tangible changes in the way clinical trials are being designed and conducted. While regulatory authorities may be initiating some of this change, it is the advancement of personal technology that is truly driving it forward.
Virtual First Steps
In 2011,Pfizer was one of the first companies to dip their toe in the virtual trial waters with the REMOTE trial(1). REMOTE was the first randomized IND study in which patients could participate in any geographic location, using electronic tools. The trial actually encountered enrollment difficulties – perhaps due to a more elderly population (it was an overactive bladder study) either not comfortable with using the technology or not comfortable submitting personal information electronically.
More recently, Science 37, a Los Angeles-based research and technology company, has partnered with both Sanofi and Otsuka to further the virtual trial journey. Science 37 uses their Network Oriented Research Assistant (NORA) to compete in the virtual trial space. NORA is 21 CFR Part 11 compliant and enables patients to participate remotely.
These siteless trials can be a godsend for patients that are not capable of traveling to an individual investigative site. With the obstacle of travel eliminated from the equation, recruiting patients for participation not only becomes much easier, but it also opens up the patient pool significantly. The patient’s home essentially becomes the investigative site. Any blood draws or procedures that cannot be conducted there can either be conducted by a mobile nurse or a clinic close to the participant’s home.
[inlinead-1]
Regulatory Impact
To date, the FDA has been very supportive of virtual trials. In 2015, the FDA began seeking input for “using technologies and innovative methods” to conduct studies(2). Their recent guidance for electronic informed consent provides helpful procedural information to companies on different electronic methodologies that can be used(3).
In addition and more recently, the FDA has announced a pilot pre-certification program – not for technology products, but for developers of them(4). The intent is for the FDA to assess a firm’s safety in product development so that each product would not require regulation. Nine companies are part of the pilot program (including Apple, Samsung, and Fitbit) so wearable technologies will continue to pave the way for more patient-centric studies.
The proliferation of wearable devices for vital signs, diabetes detection, arrhythmias and range-of-motion measurements will only increase as the capability of healthcare technology enhances.
Clinical Research Implications
As researchers, the patient always comes first. Patient-centricity has been a buzzword for quite some time, and now enhancements in personal technology are genuinely making it a reality. Accepting this new technology as part of our toolkit makes good sense from both a patient and data perspective. While we may not necessarily see the wearable device, we definitely will need to understand and interpret the data that is collected by it.
One significant benefit of virtual data is that it is collected much faster than data on a case report form – that means decisions can be theoretically made sooner. Second, like ePRO, since the original observations are entered directly into a computerized system, the electronic record is the source document, removing any manual oversights in data transfer.
Access to data has never really been a problem – it is the acquisition of it that has changed and will increasingly change over the next decade. Questions about how much data is too much have yet to be answered – especially with the increasing availability of electronic health records (including Apple’s recent foray into this area).
Is the virtual trial the answer to every study? Of course not. However, if more patients in need of treatment can be reached because of this technology, there are significant benefits to embracing it.