Love your smartphone? You’re not alone. According to Nielsen(1), more than 50% of all US cell phones will be smartphones by the end of 2011. The rapid growth in smartphone use has major implications for clinical trials, as the availability of inexpensive yet powerful smartphones and tablets with high-resolution displays, full touch screens, and full-time network connections will enable mobile interactive response technology (IRT) solutions to accommodate the needs of everyone involved in a study. By connecting the study team and participants in a controlled manner, new technologies will allow studies to be conducted with greater efficiency, greater accuracy, and lower cost. As changes driven by mobile IRT and other mobile clinical technologies take hold, study protocols will begin to directly leverage mobile technologies by requiring their use.
If you’re a study monitor or project manager, you’ll be able to use your mobile device to view real time study reports that provide detailed enrollment metrics including screening, screen failure, randomization, and discontinue rates. Messaging capabilities within the IRT will automatically alert you to potential study issues such as low stock levels at depots, pending lot expirations, or compliance situations.
As mobile IRT becomes more common, the overlap between IRT and electronic patient reported outcomes (ePRO) solutions will expand. While ePRO systems are used at study sites to collect questionnaire input from patients, they generally do not support IRT functionality for tasks such as patient randomization, drug assignment, and drug supply management. With the ability to deploy mobile IRT support for patient ePROs, sponsors will likely choose mobile IRT to support ePRO instead of two separate systems.
As for electronic data capture (EDC) systems, suppliers may find it difficult to offer full EDC functionality using mobile technology. The requirements for complete information-gathering on case report forms necessitate inclusion of far more data points than is usually required in IRT and ePRO solutions. Such requirements will likely keep the primary EDC user interface on the desktop. However it is likely that certain aspects of EDC systems such as reporting will go mobile. Some EDC providers may also consider directly supporting ePRO data gathering by implementing mobile interfaces that are directly tied to the EDC server.
For certain types of trials, mobile IRT solutions may allow studies to be designed to combine actual study site visits with “eVisits”, whereby the patient uses the mobile device to record pertinent information. In some cases, the eVisit may utilize peripherals that complement the mobile device to allow patients to self-report key information. This capability may help lower the cost of conducting clinical trials.
As patient information-gathering applications become available in mobile form, computers in treatment rooms will be replaced by tablets, with the expectation that IRT and other clinical trial technologies will be available on these devices.
Are you intrigued by the speech recognition and text-to-speech capabilities offered by some of the new smartphones? These technologies will eventually be incorporated into mobile IRT solutions, enabling hands-free utilization of clinical applications by doctors, nurses, and site personnel. In addition to facilitating accurate information-gathering and dissemination, these applications will enable medical professionals and site personnel to focus more on their patients, while also simplifying the user experience.
Adoption of mobile clinical technologies by the user community will likely raise expectations of access via multiple devices and computers. Clinical technology providers and IT teams will need to define and execute a clear strategy to ensure consistency across the spectrum of computing devices. The expanding array of choices for users to stay connected to their studies will require study teams to increasingly rely upon robust technology and networks, thus raising the bar for reliability.
The advent of mobile IRT solutions promises to expand the communications possibilities for those involved in clinical trials. What does this mean for CROs? At the very least, CROs will need to develop and maintain expertise in matching a greater variety of technologies to the needs of particular studies. As mobile clinical technologies emerge, trial sponsors will expect CROs to propose innovative solutions that may require the seamless integration of technologies and support services from multiple suppliers. The choice of mobile devices to support clinical trials will be an important consideration, as will the management of device access for study personnel and patients. Suffice it to say that the mobile device may someday be as essential to the conduct of a clinical trial as the stethoscope.
Reference
1. Entner R. Smartphones to overtake feature phones in U.S. by 2011. Nielsen Wire, March 26, 2010. http://blog.nielsen.com/nielsenwire/consumer/smartphones-to-overtake-feature-phones-in-u-s-by-2011/. Accessed October 27, 2011.
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