Riding In Cars With Researchers

There is a lot of drivers for the waste, costs, and delays of getting new innovative therapies to the patients that need them.  Dr. Kingsley talks about what precision enrollment means and how it will reduce a lot of waste throughout the industry.

Today we are going to interview Felicia Irvin, Director of Sales and Marketing for IACT Health, a multi-specialty research site.  She has about a decade of experience in finding patients for research trials.  She talks to Dr. Kingsley about recruitment methods and strategies.

Today we are going to talk about commodities and site differentiation.  As an example, let's talk about copper. Copper is a commodity. What does that mean? It means there's no differentiation. It means that if I pull copper out of one mine and copper out of a different mine, they're both the same. Copper is copper. Because there is no differentiation, I can't really tell the difference, so they should be priced the same. In fact, if one of the mines is willing to sell it to me cheaper, I should buy it from the cheaper mine because copper is copper. That's what a commodity is. Sites have been commoditized.  Actually, we largely did it to ourselves. Sites are undifferentiated.  Sponsors and CROs, despite all of their intelligence, still struggle and fail to tell the difference from one site to another.  

I'm going to talk about the word reSEARCH and why I pronounce it as I do. I frequently have people who will ask me, “why do you pronounce it that way?” Research, if you look it up in the dictionary, you can put the accent on either syllable. It can be reSEARCH or it can be REsearch. Now, in my experience, most people seem to pronounce it REsearch, so why do I choose not to? Why do I choose to put the accent on the second syllable?

How do you predict which sites are going to perform the best on research trials? A recent study found significant evidence that the combination of a certified PI and a certified research coordinator produces far better enrollment, better engagement with patients, and far better quality with fewer errors or protocol deviations. Find out more about how to choose the right site for a research trial.

Dr. Andrew Pippas is an oncologist at John B. Amos Cancer Center in Columbus, GA.  Find out how he feels about clinical research and why he thinks patients should participate in research studies.  He discusses the future of oncology treatment and gives advice to other oncologists on the best way to get involved in clinical research trials.

“Will my other physicians be upset if I enter into a clinical research trial?”  The answer is NO. Patients frequently have that fear and I’ve being seeing it for nearly 20 years.  Patients will ask me, “If I enter a research trial, will my physician(s) be upset with me?”  They wonder If they enter into a research trial with their pulmonologist, will their primary care physician be upset that they did so.  Or vice versa - if they enter into a trial with their primary care physician, will their specialist be upset with them.  I’ve mentioned in previous episodes that we collaborate with almost all of your physicians. I can tell you definitively that physicians are amazingly supportive of clinical research for lots of reasons. Learn more about these reasons in today's episode.

Today I'm going to answer a question that I frequently get from patients….”if the study drug works for me, can I continue to take it at the end of the trial?” Unfortunately, usually, no. Why? The point of research is to have a systemized process whereby we can look at the safety and efficacy of something stepwise, where piece by piece we learn more about the safety and the efficacy of something. That's why the whole thing exists and that's why we can't just simply give experimental compounds to people without regulatory bodies like FDA, EMA, and Health Canada looking at, vetting, and approving our ability to move forward. The process is slow, but it exists for a reason. It exists to protect you and that's a good thing. The downside is if you got benefit in a research trial, you can't simply stay on the compound that we used. Are there exceptions?

98% of patients who’ve been in a research trial readily say they would enter another – nearly 100 percent! 96% say that they would refer friends and family into research trials. 96% gained such a level of confidence from their experience in research, they would recommend friends and family to research. That's dramatic! As physicians, we have to start talking about research more to our patients. We have to get more publicity around the benefits and the wonderful things of research because it's a tremendous benefit to patients, to physicians, to all of healthcare in general and frankly to our economy. This is how innovation happens. This is how we learned to cure cancer. This is how we make all of these game changing breakthroughs that we're able to. So, patients, if you get involved in research, trust me, you’ll love it and spread the word!

What are virtuous and vicious cycles? They are chains of events, many times very complex chains of events, that are like dominoes:  One thing is contributing to another thing, is contributing to a third and a fourth, and they are self-reinforcing - heading in a certain direction. They'll continue in that spiral until an external force breaks the cycle and allows the chain of events to change. These cycles are everywhere. They're in our bodies, in our own biochemistry, self-reinforcing cycles in a direction. They are in economics, in how cities attempt to change neighborhoods from being in dire poverty to entering the middle class, and in the research world. They are even in our own family dynamics: how we raise our kids and how we run our families.  But I'm specifically going to talk about the research world and I'm going to talk about the fact that I believe we are in a vicious cycle when it comes to sites and principle investigators, and what I think we need to do about it.  

The use of technology at clinical research sites improves efficiency and quality for sites and Sponsors. The use of electronic regulatory binders - eRegulatory - prevents errors and adds to the professionalization of our industry. Find out what regulatory means in the clinical trial world and the benefits of using eRegulatory.

Dr. Kingsley talks about electronic source documents -  its purpose, what it does, what it shouldn’t be, why you need it, and how the industry should react.

Dr. Kinglsey interviews Dr. Maria Mascolo about the changes and breakthroughs in pulmonology.

Dr. Kinglsey interviews Dr. Steven Leichter, an endocrinology specialist, about how clinical research has changed over the years. 

Dr. Kinglsey interviews Dr. Paul Weinberg about how to successfully get involved in clinical research from a physician's standpoint.  What characteristics make a physician successful in research, who shouldn't be involved, as well as how to talk to your patients about volunteering in a research trial.

We are doing a two-part series about changing the world.  In this episode, we are talking about high-quality research protocols that go off the tracks.  Sometimes there is great research that actually doesn’t produce the result we wanted to find.  It doesn’t give us the answer that we sought simply due to the inefficiencies in research today.  We have to improve the research trial process. 

I want to change the world!  We are going to do a two part series on changing the world.  Today we are going to talk about the cost of healthcare. The largest driver of the cost of healthcare today is pharmaceutical cost.  Drugs, devices, and biologics that we have to use in healthcare today are a prime driver of what drugs cost.  Why are drugs so expensive?  

We are going to talk briefly about what a balanced scorecard is and then I’m going to focus in on quality. If you focus too heavily on one metric you can do so at the expense of others.  In research sites, if I focus too heavily on enrollment, or finding patients that meet criteria for research trials, I can do so at the expense of the quality of my data. And, ultimately, that is not serving the industry the best that I can.  A balanced scorecard is where you pay attention to an assortment of metrics so that if you do well on all of these, you are in the sweet spot.  You are serving the industry in the best way you possibly can in any given moment and time. In our company we talk about EQTCS - Enrollment, Quality, Timelines, and Customer Service.  If we achieve great enrollment (putting patients into trials), the quality of the data we are producing, adherence to the timelines, with great levels of customer service to our patients, our physicians, and to the industry, then we are in that sweet spot. Today we

We are completing our current discussion on balanced scorecards. Remember a balanced scorecard is that sweet spot between meeting all of the needs of your customers and the health of your company. I’m speaking to research sites in particular on what should be included in your balanced scorecard. I think fundamentally what our customers want of sites is what I refer to as EQTCS - enrollment, quality, timelines, and customer service.  Today we are talking about customer service.  Now, obviously, in any business, customer service matters. But the reality is that most companies don’t measure it. Most companies go on the assumption that their customer service is good if not great. But the reality is that is not always the case. To paraphrase a famous quote - 50% of the companies you know are below average.

Today we are going to talk about timelines.  Our customers need us to move rapidly on everything. Our customers want us to be able to make rapid decisions on feasibility questionnaires, rapidly start-up a study, rapidly enroll the first patient in that study, quickly do query resolution, database lock. A quick recap of what we discussed in prior episodes - a balanced scorecard is the sweet spot of KPIs (Key Performance Indicators).  A site’s customers need something from you and I argue that they need EQTCS - Enrollment, Quality, Timelines, and Customer Service.  Your balanced scorecard is the balancing point of the health of your research site with servicing the needs of your customers. I would argue that EQTCS needs to be in any site’s balanced scorecard.