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Insights & Perspectives

4 Ways to ClaimIt: Scenarios for Using Mobile Clinical Trials

Jul 18, 2018 10:29:30 AM / by Camisha Harge

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We’re in the midst of a technology transformation in healthcare. Robots are performing surgery, visits to the doctor occur online, and medical devices are smarter than ever. Research studies are no different.

Digital technology can now enable collecting data from participants in their homes, during their everyday lives, instead of inconvenient, costly trips to the clinic. It’s as simple as having a smart phone.

Here are some examples of different research studies and how they can be conducted better, either entirely online or with an online element.

 

   Cancer Study

Some in this industry might say that a cancer research study will be the last to transition to a digital platform. We disagree.

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Site visits may always be needed in a cancer study. However, there is also the need to collect research study data related to quality of life (QoL) and patient reported outcomes (PRO). This is where digital and virtual solutions are ideal, as QoL and PRO measurements can be more accurately reflected in these environments, and thousands of data points related to a patient’s emotional and physical well-being can be collected daily as part of the study. In addition, direct upload of the data from connected study devices, such as blood pressure monitors and Bluetooth scales, can support a patient’s questionnaire responses, and direct upload from devices such as Fitbit or Apple Watch can detect sleep quality and energy levels. Moreover, the use of telemedicine and facial recognition tools can show emotions, connecting a positive or negative experience of the study drug. Most importantly, including the requirement of a patient to conduct in-home assessments with portable equipment and/or requiring the wearing of sleep or activity trackers as part of the study protocol allows for real-time reporting of quality and outcome data.

We all know that the FDA will not approve a drug simply on these QoL and PRO measures. However, this data does contribute to product labeling. If a patient has a grim prognosis and is likely to die, a doctor may choose to prescribe the therapy that has the most positive patient reported outcomes and emotional responses, or that demonstrates increased sleep quality and heightened energy levels, all to allow the patient to experience the greatest possible quality of life.

 

   Medical Device Study

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Let’s use one of the most common medical devices as an example: hearing aids. Hearing aids need to perform in every situation, from a noisy restaurant to a quiet home. Instead of requiring visits to a clinic and asking a participant to recall moments when the device did or did not work properly- which is a common issue when trying to assess performance of medical devices within the constraints of a site-based study- why not track performance in real time? A mobile phone can detect real-time decibel levels, and a participant can enter information detailing how the device responds.

Another common issue with assessing medical devices is trying to determine misuse of the product. This is the case when trying to assess the effectiveness of a bone fusion stimulator that is used when a broken bone does not heal. Patients often improperly use the product or forget to use it, which reflects poorly on the device, but is not reflective of its effectiveness. Imagine the benefit of tracking compliance in the moment, while the patient is meant to be using the device in his/her home. Enabling patients to answer questions in real-time about their use of the product will allow you to obtain more accurate responses to questions, as opposed to what you get when questions are answered two weeks later at the next clinic visit.  Moreover, if you notice that no data points have been collected from a particular participant, you can send a reminder straight to his/her phone, prompting him/her to use or answer questions about the device.

 

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   Consumer Goods Observational Study

Imagine a scenario where a hair care company wants to gain insight into the perceptions of people’s hair care regimens. 

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A traditional study would cost millions and would produce limited data. On the other hand, a digital study could allow for collection of optimal hygiene data for a vast array of hair types across multiple environments and would result in minimal inconveniences for a participant with high rewards for the sponsor. Study participants would simply answer daily questions about their hair care regimen and how they perceive their hair each day, and even take a picture of their hair on their smart phones.

The hair-care sponsor could then take the collected data points to create an algorithm – put in your hair type, how often you prefer to wash your hair, how you style your hair – to intelligently recommend the best of its products for each type of hair, and the best way to use them.

 

   Interventional Study of Vitamins, Minerals and Supplements

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Let’s pretend you have discovered the latest vitamin or supplement to help increase an athlete’s endurance. How do you prove it without spending millions of dollars on a site-based clinical study?

Imagine the ability to measure in real time the intensity of a workout, along with measurements such as blood pressure, resting heart rate, and blood oxidation. All of this is possible in a digitally enabled study. A participant can take his/her blood pressure at home using a Bluetooth blood pressure cuff and the data integrates directly into the digital study platform.  As the participant exercises, the data from the activity tracker and heart rate monitor is sent directly to the study database. In a digital study, thousands of data points can be collected, instead of just a few.

 

For too long, we’ve been inching along, using the same archaic model, doing our best to interpret real-world impact in an artificial, clinical environment.  Imagine the possibilities of simple, real-world, real-time data collection through the vast and growing universe of health-tracking technologies. Resorting in the traditional way is akin to seeking faster horses instead of just getting in the car.  The next generation for research studies has just parked curbside. Strap in and watch where we go.

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Topics: Sponsors

Camisha Harge

Written by Camisha Harge

Camisha Harge is the Vice President of Clinical Operations at ObvioHealth. She has global drug development and clinical operations experience across a variety of therapeutic areas, including cardiovascular, dermatology, gastroenterology (liver disease), hematology, infectious disease (HIV, HCV, HBV), inflammation (IBD), neurology, nephrology (chronic kidney disease), oncology, and ophthalmology. Camisha is an expert in ICH-GCP guideline application, strategic clinical trial planning and execution, and clinical program quality management. In addition to development and operations, Camisha has established successful strategic Sponsor-CRO partnerships that have effectively fostered innovation, led to recognition of efficiencies, and resulted in expedited milestone achievement. Camisha earned a BA in Biology from Mills College with a focus on immunology and human biological sciences.

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