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Were the 1990s the “Good Old Days” of Clinical Technology?

By: Hugo Stephenson, Executive Chairman of DrugDev

Be honest – would you really trade the technology of today for the technology of 20 years ago? Do you miss giant projection TVs, thousands of CDs, car phones the size of suitcases, and the revolutionary Windows 95?

No one would blame you for wanting to stay current. Today’s technology is convenient, fast and mobile in a way that few of us could have predicted even back in the 1990s. In fact, the advancements of the last 20 years have made many aspects of our lives easier than ever.

So why, then, in my unique dual role as a principal investigator in Melbourne, Australia – and the Executive Chairman of leading technology innovator DrugDev – do I long for the past?

It may sound counter-intuitive, especially from me, but the processes we ran back then made it so much simpler for sites to run a clinical trial. To understand my mindset, let’s take a trip back in time to 1999:

My study coordinator and I were tasked with enrolling, and treating patients. Back then, that meant filling out large binders of forms from sponsors – non-carbon triplicates. Every visit, we would fill out the forms supplied by the sponsor with the patients’ information and send them back. If there were any questions about the data we supplied, they faxed us back and we would record any changes as needed. That was the end of it.

Sponsors would take the forms and send them off to a data processing facility to be double-data entered in a database. Training was focused on the protocol, supply management and safety – it was still time consuming, but it was relevant to our responsibilities.

Nowadays we understand the flaws of this system – the data quality and efficiency concerns to name just a few. It makes sense that companies – such as DrugDev – would come along to “fix” the process.

Flash forward 20 years later and a clinical trial site is rife with computers, tablets, and smart phones. Today, instead of completing forms, we’re given access to online software that requires my study coordinator to remember multiple logins, become familiar with multiple (counterintuitive) user interfaces, and deal with multiple ways that our sponsors want us to things (e.g. enter these diagnoses here, but not here) – she’s a wonderful coordinator but she’s not a data specialist. We spend a tremendous amount of time training on each system’s differences and learning the different ways to input data. And we still get emails and calls weeks after “acceptable” data entry when sponsors change the way they want to deal with data as it starts streaming in.

As sponsors jumped at the chance to implement new site-facing technologies and processes they ended up creating a fragmented ecosystem of different software, hardware, vendors and processes – one or more for each “silo” that exists within the sponsor/CRO world. Unfortunately, this muddied the waters for sites when it came to performing basic functions such as patient enrollment. These days, we spend more time learning new systems, training, entering data, and troubleshooting than we ever did back then.

In parallel, there has been more pressure on “fair market value”, and downward price pressure on what sites get paid – so sites are feeling that they are doing a lot more, for a lot less. At DrugDev, we understand that we either need to pay sites more to do the extra work or make the process simpler for them. So, we’ve chosen to make things simpler.

My perspective as a site has been a guiding force behind the creation of our DrugDev Spark™ platform. When you are working to run clinical trials every day, in addition to seeing patients in a private practice, it becomes clear that by industry picking so-called best of breed point solutions that don’t talk to each other, the industry has only made matter worse for their clinical site partners.

It’s all done with the best intentions, to provide sites with tools that help them do their jobs faster. In reality, speaking as a site myself, I’d rather have one system that does everything well enough to get the job done, than 11 separate systems that each do one (and only one) thing a little bit better. Talking to sites around the world, it’s clear that I am not alone.

Simply stated, providing disparate systems to sites may make it easier for teams within a sponsor or CRO, but it creates a real headwind for sites that just want to focus on patient recruitment and care. Sites need a single system with one dashboard, one set of rules, and one set of passwords. Anything else just complicates things.

With DrugDev Spark, we’re trying to create the best of both worlds, but we’ll be happy so long as sites can use one system for a dozen or more tasks without having to learn, remember and log into a dozen different systems. We’re doing this by combining investigator experiences with the needs of sponsors and CROs.

To accomplish this, our professional services team (many of whom are prior study coordinators themselves) and our development team worked together to analyze each component, ensuring it was easy to use and made sense to sites. It also required each of the components to “speak to each other,” ensuring that sites received one single experience.

While DrugDev Spark™ is the first end-to-end trial operations solution, it’s not the end of my work. If we’re not looking at how our software makes things easier for sites every single day, than we’re not helping anyone – and our culture at DrugDev is built on this philosophy of helping the world do more trials.

At the end of the day, you don’t need to be a principal investigator to think like a site when developing new technology. Go out and talk to study coordinators. Shadow them as they meet with patients. We’ve had plenty of developers at DrugDev do exactly this. You’ll quickly understand why they might long for the past – even if it means giving up Facebook, Twitter and Candy Crush.

Our job as a technology provider, and I think we are on the right track as an industry, is to come together to combine the simplicity of yesterday with the convenience of today. Only then will sites like mine give up yearning for the past.

(my Terminator 2 Pinball machine of course, is here to stay.)