A Big Moment for Diagnostics and Medical Device Clinical Trials

The medical device and diagnostics industries may not represent the face, so to speak, of clinical research. That distinction may belong to pharma, with its blockbuster drugs and lion’s share of the total number of clinical trials registered worldwide. But it would be a folly to underestimate the surge of energy, coming from both industry players and regulators, moving diagnostics and medical device clinical trials forward. To those paying attention, it’s clear as day that in these industries, big things are happening.

From 2010 to 2017, diagnostics went from representing just 0.7% of all clinical trials worldwide to representing almost 4%. In the final year of this time frame, the raw volume of diagnostics trials nearly quadrupled. Medical device clinical trials, for their part, have grown 5% faster than the rest of the clinical trials market, and represented 9% of the total number of registered trials by 2017 – up from less than 7% in 2010.

It’s a time of opportunity for device and diagnostics research. What’s driving this growth, and what are the fundamental eClinical considerations facing researchers seeking to stand out in this booming environment?

The fuel moving medical device clinical trials forward

When it comes to growth in medical device clinical trials, there’s no single cause. Numerous factors have conspired to set the stage for a surge in device research. Some of these are technological in nature:

1. Advancements in clinical research, particularly diagnostics research, necessitate more technically sophisticated medical devices.

2. Virtual trials are becoming more prevalent, with the widespread availability of the internet and other technologies including electronic health records.

3. As the healthcare industry works to improve the quality of care offered to patients, there’s a growing need for devices that can minimize the invasiveness of surgery and make patients more comfortable.

Perhaps the biggest factor driving this growth, though, is regulatory. The FDA has taken a particular interest, of late, in updating the regulations governing medical device clinical trials and stoking innovation. Regulators have become more open to device trials accepting data collected overseas. FDA Commissioner Scott Gottlieb recently released a statement announcing the agency’s intention to modernize the 510(k) program “to help keep pace with the increasing complexity of rapidly evolving technology.”

What about diagnostics?

At the heart of recent growth in diagnostics are innovations in some of the hottest areas of clinical research. One of these is companion diagnostics, an area growing a full four times faster than in-vitro and in-vivo diagnostics.1 By empowering researchers to make biomarker-based predictions of a drug’s effectiveness on a given individual, companion diagnostics make it easier to focus trial enrollment on likely responders, thereby maximizing a drug’s chances of success in late-stage trials. At a time of ballooning clinical trial costs, the value of such an innovation is hard to overstate. And regulators have taken notice, with the FDA coming out in favor of more efficient development of companion diagnostics.

It doesn’t stop there. Companion diagnostics have been tied to advances in the effectiveness of immunotherapy, which in recent years has gone from a buzz to a roar in oncology circles.

Striking while the iron’s hot – with a smart eClinical approach

As the markets for diagnostics and medical device clinical trials grow, researchers have reason to celebrate. But they also face a challenge. With more trials taking place in their space, they’ll be facing more competition from organizations racing to be the first to market with a new product. Victory will belong to those organizations with the tools and resources to clear data management hurdles and get their trials done faster. For device and diagnostics companies, this means investing in a flexible and intuitive eClinical platform tailored specifically to the needs of these studies.

This is where too many device and diagnostics researchers stumble. The modus operandi of legacy systems – complex programming requirements, on-premise installation – doesn’t fit the priorities of device studies with small patient populations and diagnostics studies with simple designs. These studies expect short timelines that get extended thanks to the logistical headaches of their EDC. As a result, many device companies still collect their data on paper.

But with technological innovation pervading every aspect of clinical research, it doesn’t have to be this way. Diagnostics and medical device clinical trials today have, at their disposal, eClinical resources that keep their study build in their own hands, eliminate costly dependencies related to programming and monitoring, and shorten study timelines. This has significantly raised the stakes of eClinical vendor selection. And successful organizations will be those best able to navigate it – and to arrive at an eClinical platform tailored to them. This is the key to taking advantage of the opportunity taking diagnostics and medical device research by storm.


WHO International Clinical Trials Registry Platform (ICTRP), January 2018