The use of new tech in clinical trials is mutually beneficial to both the clinical research and technology industries. It enables the former to make great strides in areas such as efficiency and patient engagement, while tech developers gain access to a large and growing new market. But it also brings challenges. Clinical trials are conducted according to standard operating procedures, both at research sites and regulatory agencies, that will have to adapt to the use of items like smartwatches and other devices. These often decades-old norms are deeply entrenched, and moving them can require extensive communication and collaboration throughout the industry.
That this communication and collaboration is taking place today is encouraging. It is a sign that the industry recognizes the utility of mobile tech for their trials and views its implementation as worth the effort of reviewing industry norms. Here are some of the questions raised about the tech revolution, and some of the steps the industry is taking to answer them.
What are the concerns?
From wearables to smartphones to social media, the range of devices and platforms that have shown utility in clinical trials is wide. But the wider the range, the more challenging it can be to ensure that they all meet the needs of a clinical trial. Will a Fitbit, for example, track all aspects of a patient’s response to a drug that a researcher needs to observe in order to determine that drug’s efficacy? One avenue through which mobile tech can lead to savings in a trial budget is through a “Bring Your Own Device” (BYOD) approach, in which patients use their own smartphones, tablets, and laptops to complete trial-related functions such as ePRO surveys; but do all of those devices offer the same potential for use in ePRO, or are some not as suitable as others? Will a BYOD approach undermine efforts at patient diversity by excluding those who don’t own the necessary devices1?
There are other concerns on the regulatory front. Researchers must be certain that all devices adhere to the government’s guidelines related to data gathering, patient privacy, and transparency. But it can be difficult to determine if a device could be used in a way that risks contradicting guidelines written without that device in mind. Regulations established before the advent of a new technology may need to be revised if that technology is to be utilized.
The Industry Responds
To verify that all devices used in a clinical trial possess the necessary functionality, an equivalence test must be performed on those devices in advance. While this kind of extensive verification may seem, at first glance, to risk negating the time and cost savings originally proffered by approaches like BYOD, this concern may be misguided: the necessity of equivalence testing has given rise to an industry of products designed to handle the process efficiently1. On the regulatory side, the research community and the FDA are currently volleying ideas for how best to establish a framework for the use of new tech in clinical trials. Late last year, the FDA requested more information on how researchers were using such technology. Now, with the benefits largely proven and the technology ready to go, the industry is petitioning the FDA for more concrete guidance on the best way to use it2.
Tailoring an industry to the new technology that affects it is not always easy. But in the frenzy of work and discussion that has come on the heels of new tech in clinical trials, it is clear that the clinical research industry considers the benefits well worth the effort.
1 Watson, Chris of Exco InTouch; The Truth About BYOD: How To Implement Appropriately In A Clinical Study; Clinical Leader; 19 October 2015
2 Brennan, Zachary; Industry Calls for More Guidance From FDA on New Clinical Trials Technology; Regulatory Affairs Professionals Society; 11 May 2016