Riding In Cars With Researchers

NASH is a disease without a therapy. It's a situation where there's an inflammatory response in your liver. Type 2 diabetes and obesity are our large contributors to this, and sometimes you can have obesity and Type 2 diabetes and you'll never develop liver disease. And sometimes, all of a sudden, you will develop an inflammatory response that will cause scar tissue formation in your liver and that can lead to liver failure. That's kind of what NASH is and there's no therapy. And because there's no therapy, doctors under-diagnosed, because what's the point in diagnosing you?

Herd immunity doesn’t work with the flu, nor the common cold. Dr. Kingsley discusses this and the scientific and ethical factors that go against the concept of herd immunity in this week’s episode. 

The fact that these trials got put on hold should be evidence to you that these companies are maintaining their ethics. It should be evidence to you that they are not putting profit ahead of patient safety. These trials cost billions of dollars. Putting a trial on a pause costs these companies a tremendous amount of money, which is evidence that they're doing the right thing. 

Bottom line….you won’t know if you have COVID-19 or the flu.  There is such a tremendous overlap, even in the core symptoms of flu and COVID that telling the difference by symptomatology would be rough. And then frankly, COVID presents in people differently; even people in the same family with remarkably different symptoms. And so what that means is we're going to have to test you for both all season long, because we won't be able to tell the difference by symptoms alone. 

Let's talk about FDA's emergency use authorization. Hello, I'm Dr. Jeff Kingsley and welcome to another edition of Riding in Cars with Researchers. The FDA has the ability to get products to market faster in emergency situations. It’s called the emergency use authorization, or EUA.Normally research takes 7-10 years in human clinical trials before you would ever get FDA approval.  In an era of a pandemic, this is being accelerated like I've never seen before. Sponsors are conducting what is called adaptive trial designs, where they're blending different phases of research. They are still following the normal safety protocols that we would - it's still a gated approach. But it enables faster turnaround times and faster collection of data. 

Hello, I'm Dr. Jeff Kingsley and welcome to another edition of Riding in Cars with Researchers. Let's talk about vaccine research! Traditional VaccinesThe vaccines that you and I have both received since childhood are derived from actual viruses or bacteria; they're derived from the actual thing that infects people. And they come in two basic forms. One is a little bit safer than the other, but they're both effective.  Right now we are exploring an entirely new realm of vaccine research that is incredibly exciting, where we are in an era of genetics, the actual genetic code that could tell your body to make a very specific antibody to a very specific protein without you ever experiencing any exposure to the actual virus or bacteria. So in COVID-19 research right now, we are doing that. How does DNA Play a Part?We all remember learning about DNA in school - it's our genetic code. And we also have RNA in our bodies. RNA reads the DNA, and then it shuttles it to the machinery in your bod

I'm Dr. Jeff Kingsley and welcome to another edition of Riding in Cars with Researchers. Let's discuss the difference between the treatment trials for COVID-19 and the vaccine trials for COVID-19 19. The treatment trials we're doing for COVID-19 are with monoclonal antibodies. So what we're doing is we're taking known antibodies that can bind the right receptor, bind the right protein, and give you protection from COVID-19. And we're giving you the antibody! If you've gotten infected with COVID-19, your body has not yet figured out how to defeat it. We can jumpstart you by giving you an antibody that is designed to be effective in defeating COVID-19. It's different in vaccine research where we're giving your body a chance to build its own immunity, build its own antibodies, in advance of you ever getting COVID-19. So if you get COVID-19, we're trying to give you an antibody in advance of your own body's ability to figure it out and say, “Hey, let's h

I'm Dr. Jeff Kingsley and welcome to another edition of Riding in Cars with Researchers. Do you want to know how we're coming up with therapies and vaccines for treating COVID-19 with therapies?We are literally looking at patients who actually survived COVID-19. And their body made the right antibodies and got rid of it. They defeated it and beat the virus. So what scientists are doing is they're taking blood samples from patients who succeeded in defeating COVID-19, and they're looking at all of the antibodies. Anytime your body sees something that is “not you” (a bacteria is not you; a virus is not you). Your body is continuously looking for threats; things that are not you. When your body sees something that it says, “Hey, this shouldn't be here; this is not me”, your body then randomly starts making antibodies to it. Most of the antibodies you make are worthless. Your body makes an antibody to a protein on a cell surface that does nothing. That antibody successfully grabs a protei

Hello! I'm Dr. Jeff Kingsley and welcome to another edition of Riding in Cars with Researchers in the midst of a COVID-19 pandemic. I've stopped doing lots of videos because frankly, I haven't been riding in cars, but it's time. I'm actually heading into the office right now to see some COVID-19 patients. We are treating COVID-19 positive patients. We are diagnosing patients. We are trying to prevent family members from being able to get COVID-19 from other family members in the same household who are COVID-19 positive. And we are doing vaccine trials. It's insane, but this is what you do in a pandemic. This is why we do research!What most companies call a mission statement is what I call a passionate cause. Our company's passionate cause is revolutionizing research and changing lives. And in a pandemic, how do you revolutionize research and change lives? Well, you lease extra real estate, you hire as many people as you can, and you begin becoming a force to reckon within th

It's important for you to think proactively when it comes to patient management.  There can be issues when re-subscribing prescriptions to patients who went off of those medications for the clinical trial. Coordinating with insurance companies and pharmacies ahead of time can help with a seamless transition. 99% of patients have no issue whatsoever when finishing a research trial, but if you can do a little something extra to protect the one percent, isn't it worthwhile? 

Treat the patient, not the data point. If you do this, you will have better quality data in your research trials. You will have better quality adverse event profiles. The adverse events that you document on your patients will be far more likely to be truthful and accurate than if you do otherwise. The patients that you do early terminate, or patients that you screen fail, will be far more appropriate to have been early terminated in a trial or to screen fail. We need to treat these data points differently in research than we do today. We need to treat them more like we do in normal healthcare. 

Dr. Kingsley talks to physicians about assessing the patient instead of individual data points.  He encourages you in your research trials, think the same way you do in your medical practice. Individual data points are far less significant than constellations of data points.  Doing so will refine your quality. Doing so will ensure that your adverse event list is higher quality than if you don’t.  The patients you put in research trials will be higher quality patients. The patients that you screen fail or early terminate will have screen failed or early terminated for the right reasons, not the wrong reasons.

Today we are talking to patients about the level of training of the research staff seeing you in a research trial.  I have a dirty little secret to share with you.  There are a lot of undertrained people in the research industry.  A lot.  There are a lot of research coordinators that have not had adequate training and support when they get into research.  There are research coordinators who’ve been in research for years, but if you test them, they cannot pass a test on their research knowledge.  Meaning they haven’t learned all that much.  And the same is true in physicians.  There are physicians that are very competent physicians, have little to no research experience, but are given the ability to be Investigators in research trials.  That is a dirty little secret in our industry.  And that is something we need to stop; something we need to fight against.

As an industry, we need to recognize that cognitive overload is real and if we want a better output, we need to work hard to decrease the inputs - to simplify what we're doing as an industry. Not to simplify for simplification sake.  Not to simplify to make an Investigator's life easier.  To simplify because ultimately, we all win.

Today we're going to talk about fair market value. We're going to talk about what it is and why you should care. Specifically, I'm going to try and convince you that it's flawed in how we're assessing what fair market value is in clinical research and why that matters, why it hurts.  The definition of fair market value is different in the rest of the world versus in healthcare and research. Fair market value is whatever someone's willing to pay for a company:  in the technology space, in private equity, in venture capital. Why should you care?

We need to talk about the fact that physicians and patients aren't communicating. That's a problem and it's impacting clinical research.  Find out how the biases we harbor affect influence our behavior as doctors when recommending patients for clinical research trials.

We need to improve diversity in clinical research trials. What we're going to talk about today is (1) what diversity is  and (2) we'll talk about three strategies that you can implement to help improve diversity in clinical research trials. 

The FDA is not the bad guy.  Just like IRB, their job is to ensure the integrity of the trial and patient safety.  Find out why Dr. Kingsley thinks an audit by the FDA is not to be feared, but  something that will help you ensure you are producing high quality work.

Exceptional performers are able to manage the complexity of being a CRC.  Dr. Kingsley discusses the 2 ways you can reign and become an exceptional performer by prioritizing and blocking your time.

Dr. Kingsley discusses how to handle site level workforce issues by not thinking about CAPA as being linear - start with patients' safety, then data integrity, then root cause analysis, CAPA, study what you did, and act on what you learned from the study.  And speaks to Sponsors and CROs about training your CRAs and project managers to think this way so that they can interact with the sites in the same way.