Digital technology can now enable collection of 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.
Some in this industry might say that a cancer research study will be the last to transition to a digital platform. We disagree.
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, 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.
Although it is unlikely the FDA will 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.
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 in trying to determine misuse of the product, such as the case with 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 and 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.
Imagine a scenario where a hair care company wants to tailor a product to people’s hair care regimens. A traditional study would cost millions and would produce limited data. A digital study facilitates collection of hygiene data for a vast array of hair types across multiple environments with minimal inconveniences for a participant and high rewards for the sponsor. Study participants would simply answer daily questions about their hair care regimen and could take a picture of their hair on their smart phones.
The hair-care sponsor could then use data to create an algorithm to intelligently recommend the best of its products for each type of hair, and the best way to use them.
Let’s imagine you have developed a vitamin or supplement that has a positive impact on athletic endurance. How can you cost-effectively support a claim to this effect?
What if you were able to measure the intensity of a workout, as well as blood pressure, resting heart rate, and blood oxidation in real time? All of this is possible in a digitally enabled study. Participants can take their blood pressure at home using a Bluetooth blood pressure cuff and the data integrates directly into the digital study platform. As participants exercise, the data from their 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. Continued dependence on the traditional methods of conducting studies is akin to training horses to run vs driving a car.
The next generation of clinical research study has just parked curbside. Strap in and enjoy the ride!