Speak Out

Contributed by:

Kristopher E. Sarajian, DrugDev

NOTE: The content below contains the first few paragraphs of the printed article and the titles of the sidebars and boxes, if applicable.

Calling out Clinical Technology

Think about your phone – maybe you are even reading this on it – and you’ll probably have an emotional reaction of some kind. It may or may not be a strong reaction, but odds are there is a certain and specific feeling your phone emotes in you. For something that did not exist in the mainstream 20 years ago, our phones enable us to express our own individuality, share meaningful photos, find new places for travel, and slide the occasional piece of candy around the screen. More importantly, they connect us to the rest of our world. It’s a beautiful technology experience.

Now imagine you don’t have one phone, but many. You have an iPhone for your text messages, a Samsung Galaxy for your camera, a Google Pixel for your games. You browse the internet on an HTC. You have a Motorola exclusively for online shopping. Email is only on your LG. Netflix? Facebook? That cool flashlight app? That’s three more phones right there. Pretty soon you’ll need to invest in cargo pants simply to carry them all around.

Worse still, they are running on disparate operating systems, and none of them talk together, and the buttons are in unfamiliar places, and there’s a different passcode for each device (some want six digits, others ask you to trace a pattern, the hippest ones scan your fingerprint). Now when someone asks you to think about your phone(s), you will have a different kind of emotional reaction entirely. This is far from a beautiful technology experience.

…Which experience do you think our industry currently provides for clinical sites?

As technology has improved other industries everywhere around us, drug development has

gone the opposite direction with operations becoming far less efficient. Whatever the primary reasons, from complex protocols and restrictive I/E criteria to patient mistrust and fatigued sites, the simple fact is – despite all our fancy new toys – it costs 10 times more to develop a drug today than it did 30 years ago. Over the years, costs have continued to climb as NDAs precipitously declined. As it becomes more and more expensive and risky to test drugs, potentially life-saving treatments might remain on the shelf longer than they ever should.

With all these new automated systems, things should be easier now, not harder. So what went wrong?

The hard reality is technology providers didn’t work together, didn’t establish data standards, and certainly didn’t provide a beautiful technology experience for sites. The good news is, our industry is finally on the verge of accomplishing all three.

DrugDev believes passionately that technology is primed to transform clinical research

  • and that true change will occur by achieving these imperatives:

Industry-Wide Collaboration. Let’s face it – much of what our industry considers proprietary isn’t all that unique, and the historic blocking of certain information (e.g. investigator records) is counter-intuitive to moving drug development forward. The existence of collaborations such as TransCelerate and the Investigator Databank proves that companies are more open than ever to sharing data and resources in order to advance a common cause. In this spirit, DrugDev technology brings sponsors, CROs, sites and vendors together onto a collaborative platform to share data, streamline communications and dramatically reduce timelines.

Standardization. Clinical systems must be able to talk to each other and share information so sponsors and CROs can make smart and efficient decisions. The DrugDev Golden Number is a prime example of a groundbreaking data standard which assigns a universal identifier to global site facilities and staff. Our technology matches and masters data from numerous disparate sources (e.g. CTMS, internal records, CRO databases, collaborative resources, third-party lists) to generate reliable profiles that serve as a single source of the truth. Companies that use the Golden Number account for one-third of all clinical trials run in the world

  • and with over 500,000 investigators indexed, it can be integrated across clinical systems to track activity and understand site relationships better than ever The Golden Number is one example of a data standard that works, and we need more of them.

A Beautiful Technology Experience. Great technology features don’t do any good if no- body wants to use them. We can no longer ask sites to log into 25 different systems, each with a different interface, that make their jobs harder instead of easier. That’s why we focus so much on optimizing user experience. DrugDev Spark™, our unified clinical operations suite, is a milestone step forward for the industry, as study teams and sites are now able to manage essential operations and complete task lists not just for single trials, but across therapeutic areas and entire programs, from one convenient system that is simple to use.

We have a lot to learn from phones. When sites are asked about their clinical technology platform, we want them to smile, not smash things. Our call to the industry is to help us advance this mission of collaboration, standard- ization and a beautiful technology experience so drug development companies can do more of what they do best – bringing treatments to market that improve the lives of many millions of patients and families worldwide.

Contact us anytime to schedule your demo of DrugDev Spark™, the world’s first unified clinical operations suite comprised of proven solutions used by 85 sponsors and CROs on over 1,800 global clinical trials to date.


Posted in:

Post a Comment

You must be logged in to post a Comment.