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Hugo Stephenson MD examines his longing for the past with the advances of today's technology in this blog focused around sites.
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 Consultant of technology provider 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 companies like 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. Sites are feeling they are doing a lot more for a lot less. As an industry we need to either pay sites more to do the extra work, or make the process simpler for them.
When you are working to run clinical trials every day in addition to seeing patients in a private practice, it becomes clear 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. That’s why technology vendors are working to make things simpler. Sites want to use one system for a dozen or more tasks without having to learn, remember, and log into a dozen different systems. Technology vendors can do this by combining investigator experiences with the needs of sponsors and CROs.
This isn’t the end of our work. If software providers aren’t looking at how our solutions make things easier for sites every single day, we’re not helping anyone.
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. I’ve seen plenty of developers do exactly that. 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).
Hugo Stephenson, MD, is Executive Consultant of DrugDev. He can be reached at firstname.lastname@example.org