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Siteless: The Need for Disruption (Part 1 of 3)

July 11, 2018
Posted by: Gerald “Pharmacist Jerry” Finken, RPh, MS

Siteless: The Need for Disruption

Photo credit: iiNet

The idea and concepts surrounding virtual clinical trials would be very exciting if it weren’t for the pharmaceutical industry’s history of assimilating most, if not all new innovations, especially when it comes to technology.  Every day we read about how new technology is or will be changing clinical research and promises a better tomorrow.  When I look at drug discovery, I absolutely agree, and believe that many more early diagnosis and cures are on the horizon which, by themselves, will innovate and may even disrupt the way we think about disease and how patients are treated.  But, when I look at the impact of technology on conducting clinical trials all I see are added costs and marketing hype.  I base this upon personally witnessing the introduction and use of technology in clinical research over the past 40 years.  Just to name a few technology innovations that have changed the way we have worked and should have impacted clinical research: personal computers (8086, 186, 286, 386, 486, Pentium processors, etc.), networked workstations, laptops, tablets, hard drives, flopping drives, 3.5” discs, memory sticks, RFID, MEMS caps, fax machines, scanners, car phones, cell phones, digital cameras, video conferencing and the Internet.  What do all of these have in common?  They all directly or indirectly added complexity and costs to clinical research without affecting the strategic quality of clinical research:  getting more medications approved.   So, when I hear that the next best thing in innovation are wearables and virtual studies, please forgive me for mostly ignoring the marketing hype as these too, I would argue, will also be assimilated like the above examples.

Watch 1980s Mobile Phone Commercial

It’s not all bah hum bug though. I do get excited about all the promise and possibilities of the latest technologies, when I consider Moore’s Law.  But, with all of this excitement, I have yet to see one technology for clinical research that promises to address the most strategic goal that the industry should be pursuing:  overcoming our 90% failure rate.

In addition, we all know that technology is supposed to make things proportionally less expensive.  Instead, the technology that has been introduced into clinical research to date has done the opposite, raising the out of pocket expense to get a drug to market from approximately $0.5 Billion in the early 1980’s to $1.4B today.  Moreover, we need to ask if these new technologies have reduced time to approval or the complexities of conducting clinical research.  After all, isn’t this what technology is supposed to do?  It is like we are focusing on and congratulating ourselves on HOW we use technology and forgetting about WHY we are using the technology in the first place.

The definition of insanity (many times attributed to Albert Einstein) is doing the same thing over and over again and expecting different results.  This describes clinical research for the past 40 years. I propose we follow the advice of another, this time an unlikely great, Winnie the Pooh, strange as it is, who says in the newly released Christopher Robin movie (which I recently saw with my grandchildren): “I always get to where I am going by walking away from where I’ve been.” I propose we do the same and start thinking differently.  It is time to use technology as a tool and not as the solution.  It is time to review every aspect of clinical research.

In this three-part blog, we will review how the siteless clinical trial model can and will accomplish the goal of disrupting clinical research and change its future course for the better.

Let’s begin the discussion. To start, it must be understood that the siteless model is a service and not a technology.  We already have all the technology we need to drastically decrease costs and the time to file NDAs as well as, most importantly, to stop trials from failing drugs rather than drugs failing trials.

There is no reason why 50% of NMEs couldn’t be approved by the FDA the first time around.  We just need to learn how to better use what we already have.  Additionally, if the technology does not show an immediate ROI like wearables or virtual studies—real actual dollar savings from day one and not some future dollar savings—then do not use it.  I cannot begin to count the number of times I have heard how a new and innovative technology will save companies millions of dollars by reducing development time which many times is equated to saving $3M per day based upon the drug being approved and a $1B/year revenue.  While this sounds fine, we know that for the past 40 years 90% of the drugs fail so the new technology is really only adding to the cost of drug development.

If we think about the promises of the next round of technology to be used in clinical trials: virtual trials and wearables and the hype surrounding it, what are we really expecting to happen?  Are we actually going to drastically reduce the costs of clinical trials or cut years out of getting a drug approved?  Are we hoping virtual trials miraculously solve the recruitment problem which has always plagued clinical trials as seen with most technologies.  Are virtual trials really more patient centric? And will they help to reduce the 90% failure rate?  The answer is no. If they did, wearable and virtual trials would immediately have started reducing the overall cost of drug development, which should have also indirectly reduced the costs that patients are paying for approved drugs.

So, how does siteless help us leave this place and move to one that is truly patient centric?   To start, the siteless model does not look at technology as a solution, but rather a tool to be used by centralized and licensed healthcare professionals.  The siteless model also questions every aspect of clinical research by asking: “why”?  This is the foundation of the siteless model.  Let’s take this one step further and ask the first “siteless why” question:  Why is conducting clinical research clinician focused?  I invite you to ponder this question until next week’s #CPBlogWed when we continue the discussion on industry disruption by creating a new paradigm.

In the meantime, I invite you to share your thoughts.

 

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