When we talk to patients about the challenges they face while participating in clinical trials, they tell us that it can be difficult to integrate the study’s requirements into their everyday lives. Providing the amounts and types of data that researchers need for a study can be a cumbersome and time-consuming process, especially when it requires manually filling out journal or log book with details about side effects, vital signs, diet, exercise, treatment efficacy and more.
Significant solutions to these problems will likely come from re-thinking clinical trial design with patients’ needs in mind. But, short-range wireless data transmission technologies—like Near Field Communication (NFC) and Bluetooth—can help us to take steps in the right direction.
The healthcare industry is seeing growth in the number of health devices that offer wireless and mobile connectivity. One application of these devices focuses on transferring data about patients to a doctor or health care provider in an effort to manage disease. Additional potential exists for wireless and mobile devices to be used to make clinical trial participation more efficient, and thereby more convenient, for patients.
How is Wireless Data Transmission being used in Medicine?
So, what do we mean by wireless data transmission? For the purposes of this blog post we’re focusing primarily on devices that use technologies like Near Field Communication and Bluetooth to transmit data. Both technologies use radio frequencies to transfer information wirelessly. The differences between them lie in the allowable range between the devices, the speed of data transmission, the security of the data being shared and amount of battery power required to complete the data transaction.
Here are just a few examples of ways in which these technologies are currently being used in healthcare:
Tracking your Vital Signs
The EPI mini and Medidata’s Linq are both devices that gather information about the activity of a person’s heart, and sends that information wirelessly to health care providers.
MobileHealthNews explains The Mini as a “stand-alone device that collects ECG readings through the user’s fingertips.” It uses Bluetooth to send those readings to the user’s phone. From there, the information gets sent from the phone to EPI’s health concierge service which then routes the results back to the user via text message. If patients want to store and track their data online in a virtual health record, they have the option of signing up for EPI’s subscription service.
The Reveal LINQ device is a bit different than the Mini in two ways: it was designed specifically to investigate irregular heartbeats and blackouts, and it’s implanted into a patient’s skin in a minimally invasive procedure. These types of implantable devices have been available for a while, but according to the UK edition of Wired magazine, the LINQ is a significant step up from its predecessor which was about the size of a USB stick, required more time for implantation and could only be checked in a doctor’s office.
Taking your Medicine
Many patients struggle with fitting a medication regimen into their daily lives. “Smart” pill packaging is one possible way to make it easier for patients to remember to take their medications and report the results and side effects from them to their doctors. GemaKit, for example, is a set of adhesive sensors that can be attached to a pill, pill bottle, or blister pack. When the patient goes to take the medication, she can wave her smart phone near the sensor to pull up an online reporting app. From there, she can record that the medication was taken, and also report on any current symptoms or side effects. The system also can alert the patient’s doctor to let him know if she is feeling worse, and can aggregate data for patients in the same treatment program.
What does this mean for clinical trials?
Much like 3-D Printing and other technologies we’ve discussed here previously, NFC, Bluetooth, and similar mobile data communication tools have the potential to facilitate patient participation in clinical trials. Tools like these can inspire new ideas and open doors to a wider range of options that fit the variety of patients’ needs.
These types of devices could significantly reduce the time commitment required of patients. In clinical trials that require frequent monitoring of a patient’s vital signs and health-related activities, leveraging telemedicine can greatly improve the patient experience. The number of investigator site visits can be optimized around the patient’s schedule, eliminating unnecessary travel time and costs. The overall time needed to record information could be reduced, since data would be automatically tracked and recorded wirelessly. The data researchers receive might also be more accurate, since the technology reduces the possibilities of human error in recording data manually. In addition, patients may be able to benefit from having secure access to their data so that they can continue to use it to make future health decisions.
Of course, the success of mobile health technologies like these are largely dependent on how well they integrate into patients lives and how easily they can be adopted. According to 2012 article on MobiHealthNews.com, past attempts to offer fully mobile, remote clinical trials have had mixed results. Attempts made by Pfizer and the Michael J. Fox Foundation showed that “even qualified patients were hesitant to sign up for a clinical trial online.” And, when they turned to the pharmaceutical industry side, the study’s leaders said that they were “met with a rigid system that couldn’t accommodate mobile innovation.”
With recent news that smartphones, for the first time ever, outsold non-smartphones globally and the growing popularity of mobile health apps, it’s becoming more likely that patients will be comfortable participating in a study that relies heavily on mobile technology for data gathering and reporting. Will pharma be ready when the patients are? We’d love to hear what you think. Comment below or send us a tweet…