MedNet is pleased to introduce our first guest blogger – John Lehmann from IMARC Research:

First and foremost, while there are certainly differences in the clinical research process for drugs and devices, there is a common thread that ties these seemingly different processes together…patients. Real people exist on the other side of an investigational product and they face risk when they choose to take part in a clinical research study. So while the investigations of drugs and devices have their differences, by design these differences are intended to accomplish the same goal:  to safeguard those research participants while bringing safe and effective products to the market as quickly as possible. 

More than ever before, pharmaceutical, biotechnology and medical device companies of all sizes (not to mention CROs, research consortiums, independent investigators and animal health organizations) are looking for “Do-It-Yourself” eClinical solutions.  Given the tremendous affordability and ease-of-use of some of today’s leading cloud-based eClinical systems (including our iMedNet EDC technology platform), it’s easy to see the appeal of this approach.  If you couple those benefits with the built-in flexibility and superior control these system provide, it may seem like a no-brainer:  Why wouldn’t you want to do it all yourself?

We’ve all heard the African proverb: "It takes a village to raise a child." I’d like to extend it to say that it takes a community to make us successful. Whether it happens to be friends, religious groups, athletic teams, or business partnerships, the relationships around us make us successful. I’d like to talk about a couple types of communities and then about a specific community that has grown over the past eight years in Minnesota to the point where it is now rumored to be the largest of its type in North America.                

The Open Source community as a whole has had a major impact on my life. The knowledge that I’ve gained from adopting, modifying and deploying open source solutions is on par with knowledge gained while at university. While I have benefitted greatly from open source, so has the software itself in the form of bug reports, tutorials, code submitted, and word of mouth advertising for a particular project. Open Source Software lives and dies according to the success of its community. I never adopt anything open source unless I can see an active community behind the project. I expect frequent updates to the code base, engaged product support, progress in its feature stack, and developers listening to the end users. If any of these are lacking, the project will likely die or at the very least stagnate.

My wife and I both live and breathe in the eClinical world.  She works for a small medical device company while I lead a team of software R&D developers at MedNet. Her job is to manage her EDC-based clinical studies while I assist in managing and developing our EDC solutions to effectively manage these studies. Although we are in the same eClinical world, we approach it from different perspectives. Hers revolves around clinical research needs and wants, where mine revolves around designing and developing solutions to automate those needs and wants. It’s this point – the intersection of research needs and technology solutions – that defines an EDC company. How the company responds and reacts will determine if it will thrive or fail.  But creating innovative solutions that solve client needs and wants within a highly regulated FDA environment is easier said than done. I’ll devote the rest of this article to delve into some of these obstacles.

By my count there are at least 70 EDC vendors with a product on the market today.  So how do you choose?  It’s an important question, especially since we have witnessed multiple EDC and eClinical companies come and go over the last several decades.  I certainly don’t blame study sponsors and CROs for being a little queasy about forming a partnership when they don’t even know if the EDC company is going to be around when their studies end. We typically see three or four new EDC companies pop up every year. In many cases these new companies’ use of the latest technology can make their products, at least on the surface, look very tempting. To add to the confusion, the lines between EDC, CTMS and CDMS have blurred, making the selection process even more perplexing. 

"To consult the statistician after an experiment is finished is often merely to ask him to conduct a post mortem examination. He can perhaps say what the experiment died of." 

– Sir R. A. Fisher
Presidential Address to the First Indian Statistical Congress, 1938
 

The above quote, by one of the founding fathers of modern statistics, provides important insights into the scientific process underlying clinical research. These insights apply whether one is conducting a randomized clinical trial designed to test formal hypotheses or an observational registry that employs an ad hoc analysis approach.

As a 25+ year healthcare IT marketing veteran, I’ve had a chance to witness a tremendous technology revolution across our industry. While the adoption of state-of-the-art information solutions in healthcare has lagged behind other segments of the economy, the migration from pen and paper record keeping to sophisticated web-based solutions has dramatically impacted all aspects of the healthcare world.  The clinical research community is no exception…today’s technologies can significantly enhance clinical study efficiencies, shorten timelines, and save money.   

While the potential benefits of eClinical technologies are generally well accepted, the million dollar question is which vendor/solution should you pick?  Your choice here is vitally important…a poor choice can lead to a lot of headaches and frustration.  Worse yet, the wrong decision could jeopardize your entire study.

As a member of a healthcare technology company like MedNet Solutions we’re surrounded by clinical research, some of us more than others.  For me, clinical studies are a constant reminder of all of the work put into developing new treatments and ways to cure a wide range of problems.  I’ve seen many of my close friends and family impacted by the same illnesses or conditions that are being studied in the trial protocols I’ve read. This personal connection gives me a real appreciation for the clinical trial process and reminds me of the study participants.

We live in a do-it-yourself world where technology is running wild.  Every month, new gadgets arrive in stores that aim to make your life easier by giving you more control with more ways to do things on your own.  There is an “app” and a website for almost everything.

About 5 years ago when my wife and I were looking to buy our first house, we were eager to jump in and get going on do-it-yourself home projects!  We ended up buying the perfect townhome straight out of the 1980’s which came with a blank slate of white walls and white carpet.  Although I definitely would not consider us to be home improvement experts, we were able to do many projects ourselves which ended up saving us a lot of money – painting walls, resurfacing kitchen cabinets, changing out hardware, installing new light fixtures, etc.  With the help of the do-it-yourself/how-to websites and “apps”, we were able to get quick answers on how to tackle these items ourselves without hiring an expert.