How A Problematic Database Project Inspired Me To Revamp eClinical Software

Mike on stage discussing the vision behind Medrio

Today’s post comes to us from Medrio’s founder and CEO Mike Novotny, who shares an experience that gave him the inspiration to build the first cloud-based EDC company on the market.

Early in my career, I built custom databases for whoever needed them.

It was the mid-90s, when it was a big deal to get a website up—especially with a database behind it—and I was brought on to help companies across disparate industries navigate this brave new world. One of my early gigs was a project for a multi-million dollar prostate cancer study. We built a patient registry that included 5,000 participants, and we tracked their lab values, quality of life, etc. over time.

I’ll never forget sitting with the head of Urology at the University of California, San Francisco and asking him why they were doing the study in the first place. He replied: “Because I want to understand how prostate cancer is treated in the U.S.”

My jaw dropped. “You’re one of the most famous people in the world doing prostate cancer treatment,” I said, “and you don’t know how it’s treated?” It blew my mind.

It’s impossible to determine which treatments work if you have no idea how people are being treated. I thought, if we can at least understand how people are treated and start to have some insights into what’s successful, that would be a great step toward important medical discovery.

Here’s an example of why:

In the 90s, the medical field was just starting to realize that people were being massively overtreated for prostate cancer.

Before then, the prevailing idea among doctors was: Oh my God, you have cancer. We have to do everything we can to intervene.

But in most cases, prostate cancer grows very slowly, causes no side effects, and takes decades to kill you. So if you’re diagnosed at 70, it may not be worth treatments—which may include major side effects such as wearing a diaper forever and no more sex, among others.

It took decades to understand that people were suffering for no reason. But if we’d had good data, we could have had treatment plans that were better tailored towards patients’ needs.

And the thing is, this issue is still largely true today. Right now, doctors are sort of stuck on their own island. Maybe they read some journal articles, but they really have little data in front of them about which treatments actually work.

This needs to change.

With the right data at the right time, doctors can make decisions allowing patients to live their best lives possible—no matter what their diagnosis.

Clinical researchers were using 100% custom-developed software, which was expensive, error-prone, and slow.

Back when I built the database for the prostate study, companies would write the code and build it out from the ground up.

This was expensive and took forever.

Today’s eClinical platforms are a little better, but they cater mostly to the needs of large pharma studies with complex designs. They’ll start with a 100-page document (the protocol) describing a clinical trial, hire a project manager to define requirements, use a bunch of programmers to build it, then ask a group of testers to look for bugs. Finally, a database will be built.

But even with the database built there’s still an incredible amount of paper involved in clinical trials. The standard research process is to write the data point down on a piece of paper (the Case Report Form (CRF)), enter it into a database, and then double-check that the database is the same as the original paper (Source Data Verification (SDV)).

So, in 2005, I started my own eClinical software company to help streamline the research process.

Today, we’ve grown accustomed to technology that does what we want, when we want. So it’s no wonder today’s researchers yearn for a certain ease and efficiency current platforms lack.

That’s why our eClinical technology is better suited to researchers’ needs. With our software, no one ever has to write a line of code. Researchers decide the fields and forms to collect, drag and drop, and then the database is built for you on the back end.

What you might lose in complexity, you gain in stability and speed.

And instead of recording trial data on paper and then later transferring it to an online database, eSource—or paperless data capture— allows researchers to capture data electronically off the bat so that they don’t have to manually review paper to confirm that the data’s still correct. It eliminates unnecessary duplication of data, reduces the opportunity for error, allows for remote real-time entry of electric source data, and ensures accuracy.

This tech puts useful treatment information in doctors’ hands in the most efficient way possible—ultimately helping patients make better, more informed medical decisions.

We’ve come a long way since that trial I worked on in the 90s, and humans are living longer and healthier than ever. But trials are still becoming more expensive by the day.

This means there are major gaps in discoveries, and the right drugs have trouble making it to market.

A recent Tufts report found that getting a prescription drug to market costs drugmakers $2.6 billion. This is up from $1 billion in 2013 and $802 million in 2003. The rate of success is just 12% and it takes eight years.

But we can reverse this trend by harnessing new tech. eSource gives researchers massive cost and speed savings. eSource makes data collection efficient and improves data quality, which gets results faster and saves lives.

When it comes to human health, the stakes are high—and we have to constantly strive to do better.