Clinical trials are meant to determine whether devices, medications, or other developments in the medical field are safe for public use. These developments are at the cutting edge of the field, yet frequently, the trials to test their safety don’t incorporate the latest technologies (such as mobility).
There are reasons that companies have been leery of implementing mobile technologies in mobile trials: they’re concerned about regulatory issues, patient adherence, and cost. However, with the adoption of best practices, firms should no longer be concerned about using mobile technologies during regulatory trials.
Mobile technologies aren’t monolithic. There’s more than one kind – there are tablets, wearable devices, smartphones, and let’s not forget apps and mobile websites. And when it comes to apps and websites, there are several options available – each platform has its own language for creating apps.
So, what do you choose? There’s no single answer; your mobile technology will depend on the type of trial you’re conducting. However, there are some things to keep in mind. Make sure that the device/app is completely secure and user friendly. If you’re utilizing a device, take care that it’s durable.
Mobile technologies have disrupted the way the world does business, but that doesn’t mean that regulations have kept up with them. That’s a major reason why companies have been wary of utilizing mobile technologies in clinical trials – they don’t want to face penalties because they’re run afoul of regulators.
However, the fact that regulations haven’t yet addressed mobile technologies doesn’t mean you shouldn’t use them. What it does mean is that you should consult with regulatory agencies before launching clinical trials. The regulators can advise you so you won’t have to worry about penalties.
While it might seem like everyone on the planet owns a smartphone, that supposition might not mean that the patients in your trial will feel comfortable using them, or that they’ll use them correctly.
Before the trial begins, identify patients’ familiarity and comfort level with utilizing mobile technologies. This will reveal any potential issues (“But I’ve never used an app before”) so you can take care of them before they sink the trial. It will also determine whether patients need training (and how much of it) in order to use the mobile technology in order for them to participate effectively in the trial. Researchers conducting the trial might also need to explain exactly how gathered data will be used and what they’re doing to ensure that data is secure.
Mobile technologies have the potential to transform clinical trials, making them shorter and less expensive while still delivering accurate results. While they still represent uncharted territory for pharmaceutical and biotechnology firms, mobile technologies shouldn’t be shunned because they’re continuing to mature. By embracing them now, companies that run clinical trials can reap the benefits of mobile technologies as they deliver value to stakeholders (especially patients).