These tools have great potential but may not be applicable to every type of trial.
Mobile technology has expanded the capabilities of almost every industry. For clinical trials, this means greater accuracy of data, increased patient compliance, and a shorter timeline to get drugs to market. But is mobile technology applicable to every trial? Before committing, it’s important to consider all the qualities of your trial and how they apply to data collection.
Where is your study going to be conducted? Your patient pool is a large component in determining your ultimate study design and will vary depending upon where the study will be conducted. Mobile health devices have a wide variety of applications that can only be utilized with proper implementation and, more importantly, with subjects willing and able to use the technology.
Developed areas. Populated with a large amount of people with their own mobile device, developed areas can bode very well for sponsors looking to utilize Bring Your Own Device (BYOD) or flexible provisioning options. Conducting trials in these areas, however, often costs twice as much as they would in an underdeveloped region, due largely to quality of care and the regulatory demands of developed regions.
Underdeveloped regions. Conducting a clinical trial in rural or developing areas can hold many benefits such as lower costs and a higher concentration of patients in need of care. However, if you’re looking at a patient pool that doesn’t have regular access to broadband or devices, steps will have to be taken to implement the devices and educate the site managers and subjects on how to properly collect data. Deploying mobile technologies can offer significant return on investment as long as the implementation process is done correctly.
What phase is your trial? The data collection needs of a clinical trial are drastically different depending on the current phase. The type of data needed, the way it’s interpreted, and most significantly, the amount of data collected will vary widely.
A phase IV trial typically has a smaller patient pool. Phase IV trials are designed to confirm the efficacy of a drug rather than prove it. In these studies, paper diaries could be the most cost effective choice as the data collection is for secondary outcomes. While mHealth could still be relevant for collecting data by using a simple survey, subjects could easily use their own device.
A phase III trial might include hundreds of subjects across several countries. Managing patient compliance across such a diverse patient pool is incredibly complicated, especially when ensuring the data collected is both reliable and valid. ePRO devices can greatly improve accuracy in phase III trials that traditionally relied on paper diaries. Some trials may be able to employ the BYOD approach but it’s important to consider the necessary degree of patient compliance for your particular trial.
We recently asked Kyle Hogan, an eClinical Solutions Director with Clinical Ink, for his take on the BYOD approach in phase III trials:
“On the patient’s phone, we’re not able to install what’s called Mobile Device Management (MDM) to lock or block a patient’s capabilities to mute their phone, turn down the volume, deactivate notifications, or things of that nature. So, when leveraging a BYOD solution, these are things to consider. Some sponsors have looked at handling this as a process component and part of informed consent saying that, participation in the trial mean you’re not going to do that. In other cases, what that has resulted in, especially I find, in the phase III space, is a real commitment around the provisioned solution and full mobile device management to really block that out.”
Trials in phases I or II of the drug approval process are often “first in human” trials, when the drug testing is in its infancy, and therefore rely even more on highly accurate data. For this reason, they are often concentrated on collecting data at actual study sites, rather than remotely from the subject’s own home. However, mobile technology can contribute to these trials as well. Site managers wouldn’t have to rely on their patient’s memories to track changes in symptoms if they had ePRO devices. There are also many new advancements in wearables and biosensors that are creating new opportunities for continuous data collection outside of the lab with minimal disruption to patient quality of life. With phases I and II, the scale and budget of the trial should determine if there’s a use for mobile technologies outside of study sites.
What is the trial testing? Whatever treatment is being tested in a clinical trial, the primary endpoint is to increase survival rate and improve Health Related Quality of Life (HRQL). This naturally differs depending on the disease or condition that the drug is for. Sponsors, CROs, and site managers should work together to determine what kinds of data are needed for their specific trial and work with technology experts to determine what the best methods are for collecting that data.