Saturday, 13 February 2016

Mobile Based Remote Clinical Trials Now a Realistic Option

Web-based remote trials have been in use since 2014.  

The format replicates clinic based trials. A central clinical site oversees a process which:
  • Recruits participants over the web through questionnaire based selection.
  • Obtains informed consent using web-based methods, countersigned by a local physician.
  • Conducts lab testing in each community.
  • Monitors and collects results by self-reporting through a web-portal.
One of the main benefits of this approach is in patient recruitment. Traditional challenges to selecting a patient group, including minimising selection bias, establishing a representative group and establishing a suitably large sample size are helped by web selection. Candidates can be identified through arrival at niche websites which rank highly in search engines for keywords linked to the condition. A wider group of clinicians can be canvased through email and clinical portals. Online Support Groups can also be approached.

Groups approached in this way have been shown to be more positive about being involved in clinical trials; they are also more informed, which mitigates against low health-literacy in obtaining informed consent.

A number of recent innovations can now build on this success.

Automatic Data Collection in Remote Clinical Trails

The first is the use of disposable biosensors, which can automatically collect data and send it through a mobile or wearable device to a central server.  Such data collection can increase the resolution of the data, help avoid gaps and provide quantifiable data in near real time.  The technology is often  unobtrusive, which further improves compliance. 

Improved Safety in Remote Clinical Trials

Not only does this improve the datasets available to the trial, it also provides significant safety benefits.  Formerly data was entered on paper and faxed to the clinical team. Recently this has improved through uploading the data, but this still involves offline collection and periodic submission.

This all changes when automatic data collection is through a mobile online device.  Data is now reported in real time which allows faster analysis.  This may allow for early indications of problems with the trial drug which may warrant intervention.  It also allows clinicians to monitor adverse reactions in patients as soon as they occur.  Qualitative data can also be added by the patient in real time, including diary information and an alerting function to report severe events.

A further benefit is the opportunity to connect with the patient's support network during the trial. Most patients will share information with someone during the trial. Mobile technology allows that person to have a connection with the clinician.

Leveraging Diverse Datasets in Remote Clinical Trails

The use of mobile data linked with analytics opens up further opportunities for innovation. With consent, rich meta-data about the patients environment can be collected.  Ambient temperature and GPS location can be linked to widely available weather datasets, eg to give an estimate of air quality at the patients location. In other industries major benefits have been realised by joining disparate datasets in this way; the technique may well benefit clinical trials similarly. 

Remote Clinical Trial Coordination

A final benefit of combining these technologies is in the coordination of the trial team.  By building a more dispersed trial set, it's likely that more clinicians will be involved.  Social collaboration tools set up specifically and securely for the trial can assist in the coordination of all involved, the dissemination of information  and a route back for both two way and many-to-many discussions.  Having these coordination tools installed on tablets also allows for the input of clinicians who typically move between sites or hospitals.

By combining the use of disposable biosensors, wearable technology, mobile devices and social collaboration tools, clinical trials could greatly increase their ability to collect high quality data while improving trial safety.  Moreover, and for the first time, such technology can be deployed at reasonable cost.