To Ride a Bike – and Conduct Effective Clinical Trials – You Need Experience

Remember the first time you rode a bike without training wheels? The excitement, fear, anticipation? For a lot of us, those early efforts resulted in a skinned knee or two and perhaps some tears.  But within a few days, we were speeding down hills and around corners with the best of them.  All it took was a little experience.

Experience counts for a lot in life, including developing effective clinical trials.  Over the past decade, the process for developing new drugs and therapies has evolved considerably. Innovations in technology, a new emphasis on the patient experience, and a commitment from the FDA to explore new approaches have led to an evolution in how we conduct trials.  

Gaining Knowledge

The importance of experience was highlighted to me when Tissue Analytics launched in 2014. TA’s” concept was simple – the healthcare industry needed a much, much better way than subjective ruler measurements to track the progress, intervene and treat patients with bedsores, diabetic and other wounds or lesions.  

Our founders’ vision was that digital imaging technology – deployed on that powerful device we all carry (our smartphones) – could provide cutting-edge imaging information that measures the size, depth and other critical information.  They recognized that data from smartphones (or tablets or other hand-held devices) could be integrated seamlessly into an electronic health record (EHR) and would revolutionize patient care.  I am fortunate to attest that this vision has been fulfilled and continues to impact the lives of providers and patients. (View this great podcast interview about our early years with one of our founders, Josh Budman.)

It certainly wasn’t easy.  Wound care is a complex sector of healthcare. Conditions such as bedsores, diabetic foot ulcers, pressure injuries, and other wounds/lesions profoundly impact the elderly, disenfranchised, and often overlooked populations.  Wounds are hard to treat, and usually, success is measured by incremental improvements, which potentially influence complete healing.

However, soon after launching our clinical app for wound care providers, the impact became real. Providers were amazed at how accurate it was and how much time it saved.  Because of our success, we began to recognize the tremendous value our sophisticated yet simple-to-use platform could bring to clinical trials and research.

Lots to Learn

We entered the research marketplace full of ambition, excitement and anticipation. We were so sure of our product that we just knew we were going to change the game when it came to wound/skin care clinical trials.  

I should have remembered my bike riding lesson.  First, we had to gain some experience. It wasn’t simply a matter of giving researchers a plug-and-play imaging tool. It wasn’t just about downloading our imaging tool from the “app store”. We soon recognized we were pioneers within an emerging and dynamic clinical research marketplace, and that brought many valuable lessons.

It was eye-opening for us young and perhaps overly optimistic newcomers to the field to learn about the myriad stakeholders, regulations, security, and local laws.  But we were determined to learn and quickly began working with industry and pharma on several innovative clinical trials here in the US and globally.

A Journey not a Destination

We gained experience on the importance of technology and the need to be aware of cultural barriers that might impact access. We learned how to tweak our platform to bring more value to investigators, how to work with regulators, the importance of documentation, the type of insights most meaningful to various stakeholders and last but not least, a humanized patient experience. Without a doubt, we gained a ton of knowledge in a short period of time. 

All of these experiences contributed to our quest to become one of the most experienced providers of decentralized and virtual wound care clinical trials.  It’s also helped us evolve into other areas, most notably, dermatology, as witnessed by a recent Tissue Analytics study published in JAMA. As a result, we now work with some of the largest wound care providers in the industry, developing a full range of research programs. It’s been heartening to hear that one of the main reasons these industry leaders choose us is because of our experience.

And that’s just one reason why experience is something we strive for daily. It’s not a destination – it’s a journey. Just like riding a bike, we get better with every effort. We learn from each engagement and opportunity – to build on all our experiences and propel us to bigger and greater things…

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