Riding in Cars with Researchers
68 episodes - English - Latest episode: over 1 year ago - ★★★★★ - 4 ratingsRiding in Cars With Researchers features Centricity Research CEO, Dr. Jeff Kingsley, as he drives to revolutionize research by advancing new ideas in how research happens; literally revolutionizing the ‘how’ of clinical research. He discusses topics related to patients, physicians, and the research industry including the importance of participating in clinical trial research. His goal is to advance medicine and treatment, to improve volunteer and physician participation, and to get needed treatments to patients faster. His goal is to change lives.
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Episodes
What Happens When a Trial Unexpectedly Goes Away?
December 01, 2022 18:00 - 6 minutes - 4.47 MBWhat reasons can cause a trial to unexpectedly go away? What happens when it does? In today's episode of Riding In Cars with Researchers, Jeff Kingsley outlines some scenarios that would cause trials to suddenly close or never reach start-up despite preparation, and gives some practical suggestions for how #clinicaltrial sites can prepare for this in the future.
Clinical Site Trial Budgeting
October 13, 2022 13:00 - 7 minutes - 5.53 MBWhat is appropriate clinical trial site budgeting? How can sites go about improving their budget negotiations? Today, Dr. Jeff Kingsley outlines the steps to take in order for your site to budget for trials successfully. A full transcript of this podcast can be found on our blog: https://iacthealth.com/riding-in-cars-with-researchers/ Follow Us On: Instagram: https://www.instagram.com/centricityusa/ Facebook: https://www.facebook.com/centricityusa Twitter: https://twitter.com/Centric...
What is the right size of a clinical research site?
September 01, 2022 13:00 - 10 minutes - 6.99 MBWhat is the right size of a clinical research site? Small or large? Today, Dr. Jeff Kingsley gives insight into why he believes one site size prevails over the other. A full transcript of this podcast can be found on our blog: https://iacthealth.com/riding-in-cars-with-researchers/ Follow Us On: Instagram: https://www.instagram.com/centricityusa/ Facebook: https://www.facebook.com/centricityusa Twitter: https://twitter.com/CentricityCR LinkedIn: https://www.linkedin.com/company/centr...
How do you choose which trials you should conduct at your research site?
August 26, 2022 13:00 - 8 minutes - 6.03 MBHow do you choose which research trials you should or should not be conducting as a research site? Dr. Kingsley speaks to sites, business development professionals, and other key decision makers about the 3 things you should consider: the greater good, business development, and business in general.
How do you decide if you have the capacity to conduct a trial?
August 18, 2022 14:00 - 8 minutes - 6.06 MBWhen considering a trial for your site to conduct, you have to assess both people and site capacity. If you are not measuring your site’s capacity, it will affect your site’s performance and may lead to failures. Find out more in this week’s edition of Riding in Cars with Researchers.
What is the difference between pandemic, endemic, and epidemic?
August 05, 2022 13:00 - 8 minutes - 6.03 MBLet’s talk about the differences in the use of pandemic, endemic, and epidemic and how we use them. Is COVID-19 considered a pandemic? Find out in this week’s episode of Riding in Cars with Researchers.
Why Physicians and Patients Should Participate in Clinical Trial Research 2021
October 14, 2021 13:00 - 8 minutes - 6.15 MBIn an interview with Dr. Joseph Surber, Chief Medical Officer at IACT Health, Dr. Jeff Kingsley gets to the heart of the importance of both physicians and patients participating in clinical research trials. For physicians, isn't that why you got into the medical field - to make medicine and the lives of your patients better? For patients, participating in clinical research trials gives you an option to participate in a modality that you would otherwise not have access to as well as it bein...
Riding in Cars with Researchers - Marketing Clinical Trials
July 09, 2021 12:00 - 10 minutes - 7.13 MBDo you know where to spend your marketing dollars in Clinical Research? How do you decide what areas to focus on? What percentage of your budget should go to what medium? How to implement your strategy? In this special edition of Riding in Cars with Researchers, Dr. Jeff Kingsley has a conversation with Dr. Christine Senn, Chief Strategist of Research Designed and COO of IACT Health, where they discuss ways to improve your existing marketing, tips to help attract patients, and how to maximi...
Riding in Cars with Researchers - Using Technology in Research
June 23, 2021 18:00 - 6 minutes - 4.26 MBThe use of technology in research is potentially of immense benefit. Research requires a ton of attention to detail and it is easy to make a mistake when you are using paper or paper source documents like eSource. The use of smart technology would make that easier and enhance data integrity. Look into different technology and test them: plan, do, act, and study! Did it work? Technology will revolutionize research and enhance the quality coming out of clinical research sites.
Riding in Cars with Researchers - Direct-to-Patient Clinical Trials
June 07, 2021 12:00 - 5 minutes - 4.11 MBThere has been a movement going on for 28 years now to move research into the patient's home making it easier for patients to participate in research. The hardest thing we do is find patients who can meet the stringent criteria for research, and who have the time and the willingness to participate. If it’s the hardest thing we do, we need to remove as many barriers as possible, and make it as easy as possible for patients to be able to participate. The direct-to-patient movement is aimed at ...
Benefits of Using Project Management in Clinical Research
March 01, 2021 12:00 - 7 minutes - 5.03 MBDr. Kingsley interviews Dr. Christine Senn, Project Manager Extraordinaire, on the benefits of using project management in clinical research. She discusses the importance of certifications and how it will help you site manage your trials more efficiently. For those interested in learning more she recommends reading Lean Six Sigma for Service by Michael L. George, and Execution: The Discipline of Getting Things Done by Larry Bossidy and Ram Charan. For more information on certification pl...
Riding in Cars with Researchers - Should We Remove the Placebo Arm from Trials
February 01, 2021 15:00 - 8 minutes - 5.85 MBThe Japanese government just announced that they will be releasing a guidance document sometime around April of 2021, regarding how you would be able to submit data for regulatory approval there while using what's called real-world evidence in place of a placebo arm. So let's discuss this concept and what this means ethically and how it would work. It's a leap of faith for the industry to start thinking, “could we do this?”. But something that I always say is just because something's hard, d...
Riding in Cars with Researchers - Why Do We Need More COVID-19 Vaccine Trials?
January 26, 2021 15:00 - 5 minutes - 3.57 MBWe have a supply and demand problem. We have more people that need vaccines than we have vaccine available. It will take Pfizer and Moderna time to continue to manufacture vaccines and ramp up manufacturing a vaccine. But every time a new company gets an emergency use authorization, you're effectively instantaneously adding manufacturing facilities around the planet. Pfizer can only manufacture at this rate. Moderna can manufacture at this rate. You add another company you immediately stai...
Riding in Cars with Researchers - COVID-19 Research Ethics
January 26, 2021 15:00 - 6 minutes - 4.62 MBWe're in a situation today where we've got ethical challenges pulling in opposite directions, and that's what's creating difficulty for Sponsors today. We have an immense need to do more COVID-19 vaccine research, and we already have several that are FDA emergency use authorization approved in the US and others internationally. And so now you have a situation where patients are in research trials, they've given of themselves to be in a research trial. Depending upon if they are healthcare ...
Riding in Cars with Researchers - COVID-19 Vaccine and Viral Mutations
January 05, 2021 13:00 - 5 minutes - 4.12 MBThe majority of the COVID-19 virus that's around the world originated in Europe, not within China. There was a mutation that happened in Europe that gave that virus an advantage over the virus that came out of China. And now the majority of the virus that's around the planet is that variant that came out of Europe. And right now there's a new variant, a mutation that perhaps originated in London that we're now discussing actively. What happened in London was that the epidemiologists could se...
Riding in Cars with Researchers - Why We Need More COVID-19 Vaccine Research
December 16, 2020 13:00 - 4 minutes - 2.97 MBPfizer and BioNTech have just gotten a FDA EUA (Emergency Use Authorization). They also got EUA in England, and I believe in Canada at this point in time. We're expecting Moderna to get its’ EUA shortly, and there will be more to come. What I don't want to see is people thinking that that's it, that's the end, that there's no more need to enroll in COVID vaccine research trials. Now, why would I argue that there is still a need?
Riding in Cars with Researchers - mRNA Vaccines are Game-Changing
December 07, 2020 13:00 - 3 minutes - 2.79 MBThe traditional way vaccines are made is time-consuming. Traditional vaccines are grown, and because they're grown, they're difficult to make. They take time to make and it's a lengthier, costlier process. This messenger RNA (mRNA) technology is completely different and it's showing tremendous promise right now with the COVID-19 successes that we're having. Find out how!
Riding in Cars with Researchers - AstraZeneca's Vaccine Data Explained
November 30, 2020 12:00 - 4 minutes - 3.06 MBDr. Kingsley discusses the announcement made last week regarding AstraZeneca and Oxford University's COVID-19 vaccine candidate. What does the data set tell us? The bar for the vaccine candidates was set at 50% - meaning if you have a greater than a 50% efficacy, the FDA would consider approving your vaccine. Did AstraZeneca reach that bar?
Riding in Cars with Researchers - Pfizer's COVID-19 Vaccine
November 10, 2020 16:00 - 3 minutes - 2.39 MBPfizer just released their interim analysis showing that their vaccine is 90% effective against COVID-19! The interim analysis shows a 90% efficacy - this means the vaccine protected the patients who got COVID-19 to the tune of 90% - 9 out of 10 patients who got the vaccine were immune to contracting COVID-19. Not only did they have antibodies, but they literally didn't get it at the same rate as the people who didn't get Pfizer's vaccine candidate. That's huge!
Riding in Cars with Researchers - Diversity in COVID-19 Trials
November 09, 2020 12:00 - 3 minutes - 2.43 MBYou've heard me talk in the past about the ethical and scientific imperative to have diverse patient populations in clinical research. It is unethical and scientifically unsound to do research on white men and assume that the data is going to be the same in women or people of African descent or Asian descent or any other descent. There is an ethical and scientific imperative to have diverse patient populations. Well, in the era of COVID-19, the FDA said, “Hey industry, COVID-19 is affectin...
Riding in Cars with Researchers - NASH Research
November 03, 2020 13:00 - 3 minutes - 2.78 MBNASH 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 the...
Riding n Cars with Researchers - Herd Immunity and COVID-19
October 26, 2020 13:00 - 6 minutes - 4.45 MBHerd 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.
Riding in Cars with Researchers - COVID-19 Vaccines on Pause
October 19, 2020 12:00 - 3 minutes - 2.38 MBThe 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.
Riding in Cars with Researchers - Do I have COVID-19 or the Flu?
October 12, 2020 12:00 - 2 minutes - 1.61 MBBottom 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.
Riding in Cars with Researchers - Emergency Use Authorizations
October 05, 2020 13:00 - 3 minutes - 2.27 MBLet'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...
Riding in Cars with Researchers - COVID-19 Vaccine Research
September 28, 2020 12:00 - 3 minutes - 2.54 MBHello, I'm Dr. Jeff Kingsley and welcome to another edition of Riding in Cars with Researchers. Let's talk about vaccine research! Traditional Vaccines The 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 t...
Riding in Cars with Researchers - Development of COVID-19 Treatment & Vaccines
September 21, 2020 14:00 - 3 minutes - 2.44 MBI'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...
Riding in Cars with Researchers - Difference in COVID-19 Treatment & Vaccine Trials
September 21, 2020 14:00 - 2 minutes - 1.74 MBI'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 ...
Riding in Cars with Researchers - Commitment to COVID-19 Research
September 07, 2020 13:00 - 3 minutes - 2.46 MBHello! 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 house...
Riding n Cars with Researchers - Evaluating Data
March 03, 2020 16:00 - 4 minutes - 3.29 MBDr. 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 s...
Riding in Cars with Researchers - Patient Management
March 03, 2020 16:00 - 4 minutes - 3.05 MBIt'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?
Riding in Cars with Research - Quality of Data
March 03, 2020 16:00 - 5 minutes - 3.65 MBTreat 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 poin...
Riding in Cars with Researchers - Fair Market Value
January 10, 2020 19:00 - 13 minutes - 9.39 MBToday 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 pri...
Riding in Cars with Researchers - Certification Matters
January 10, 2020 19:00 - 4 minutes - 3.08 MBToday 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 knowled...
Riding in Cars with Researchers - Cognitive Overload
January 10, 2020 19:00 - 8 minutes - 5.95 MBAs 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.
Riding in Cars with Researchers - Diverse Patient Population
November 21, 2019 13:00 - 10 minutes - 7.13 MBWe 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.
Riding in Cars with Researchers - Communication between Doctor and Patient
November 21, 2019 13:00 - 5 minutes - 4.11 MBWe 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.
Riding in Cars with Researchers - Don't Fear the FDA
November 21, 2019 13:00 - 5 minutes - 4.11 MBThe 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.
Riding in Cars with Researchers - Site Level Workforce Issues
November 05, 2019 13:00 - 10 minutes - 7.3 MBDr. 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.
Riding in Cars with Researchers - How to Reign as a CRC
November 05, 2019 13:00 - 7 minutes - 5.1 MBExceptional 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.
Riding in Cars with Researchers - Precision Enrollment
November 05, 2019 13:00 - 5 minutes - 3.7 MBThere 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.
Riding in Cars with Researchers - The Word "Research"
September 10, 2019 16:00 - 1 minute - 1.3 MBI'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?
Riding in Cars with Researchers - Patient Recruitment
September 10, 2019 16:00 - 9 minutes - 6.27 MBToday 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.
Riding in Cars with Researchers - Site Differentiation
September 10, 2019 16:00 - 5 minutes - 3.9 MBToday 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 sho...
Riding in Cars With Researchers - Interview with Dr. Andrew Pippas, Oncologist
August 05, 2019 13:00 - 12 minutes - 8.71 MBDr. 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.
Riding in Cars With Researchers - Choosing the Right Site
August 05, 2019 13:00 - 5 minutes - 3.87 MBHow 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.
Riding in Cars With Researchers - Can I take the study drug after the trial ends?
July 16, 2019 12:00 - 4 minutes - 3.21 MBToday 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...
Riding in Cars With Researchers - Will My Doctor Fire Me?
July 16, 2019 12:00 - 4 minutes - 3.19 MB“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 thei...
Patient's Experience in Research
June 27, 2019 12:00 - 4 minutes - 3.26 MB98% 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'...
Virtuous Vicious Cycle
June 27, 2019 12:00 - 11 minutes - 7.64 MBWhat 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...