One of the biggest challenges in clinical research is poor compliance. Subjects who dropout, and who therefore do not provide data specific to study endpoints, are wasted money. A high dropout rate requires a larger sample size, leading to longer recruitment timelines and a surge in study costs.
Inconvenience to the subject and infrequent engagement with the study team often lead to low compliance. Digital technology, such as ClaimIt, makes it easier for subjects to adhere to the protocol in the following ways:
Digital studies are programmed to remind subjects to complete study activities. These reminders are sent directly to participants via their smart phones.
For example, let�s pretend a protocol requires each subject to record what time he/she takes a pill every day. Some might take the pill but forget to enter the information. Others might forget to take the pill altogether. In a digital study, the protocol could be designed so if a �take time� has NOT been entered by 6 p.m. local time, a notification is sent to the phones of those subjects, prompting them to take the pill and input the data.
These reminders are built into digital platforms, like ClaimIt, and customized to each study.
Some subjects are more forgetful than others, and therefore might need individualized engagement.
If a subject is consistently non-compliant, ClaimIt would alert study team members. This allows for a study team member, even one unable to view identifying information, to engage with the subject through the app to understand why he/she is not adhering to the protocol. A mobile platform allows for these customized interactions based on individual needs.
Let�s be real: the incentives for participating in a study are real motivators. A traditional study typically offers monetary compensation when the subject has completed.
In a digital study, it�s easy to generate more frequent compensation. With the IRB�s approval, you could program the system to generate a $20 compensation payment every week, the subject is engaged. The ClaimIt platform can deposit this compensation into a PayPal-like account automatically. This results in more accurate and complete data since participants know adherence is tied to compensation.
Let�s pretend a subject in a traditional trial experiences a headache, stops taking the study product and waits until the next site visit to report it. Once at the site, after a discussion with the PI, they both agree the headache was due to stress, not the intervention. The subject then continues consuming the study product. However, this has now lowered the overall compliance possibly impacting the end of study analysis.
Since digital technology lends itself to real-time data collection and constant monitoring, this scenario would be unlikely in a mobile study. Instead members of the study team would have been alerted to the adverse event when it happened, allowing them to engage with the subject immediately and provide instruction as to next steps.
Perhaps, the most obvious reason compliance is enhanced in a digital study: it lessens the burden on study participants. In a site-less trial, there�s no struggle to find a convenient appointment and no need to travel to a doctor�s office.
Some trials are a hybrid �a mix of digital components and traditional site visits. In these studies, much of the data can be collected using digital technology, meaning fewer on-site visits are created within the study design. In conclusion, digital tech enables study teams to engage with participants while easing the burdens that come with the traditional brick and mortar site. Mobile studies allow subjects to interact with interventions and study team members in their natural environments, instead of inside a clinic, which not only encourages compliance, but also increases data timeliness. And it�s all accomplished via their smart phones!
Joshua Lowndes, Associate Director Clinical Operations, is a physiologist with 15 years of research experience in academic and industry settings. Prior to ObvioHealth, Joshua focused on research in human obesity and metabolism, with a dual emphasis on the cardiometabolic consequences of obesity and change in weight, and on the neuroendocrine regulation of energy balance. He has designed and conducted studies used for product development, for national advertising campaigns, and for contributing to FDA health claims. Joshua has 22 peer-reviewed publications in high-impact scientific and medical journals and has authored two book chapters. Joshua is certified by SOCRA. He has a Master of Arts in Exercise Physiology from the University of Central Florida and a Master of Science in Regulatory Affairs from The George Washington University.