Riding In Cars With Researchers

What 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. 

What 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/CentricityCR LinkedIn: https://www.linkedin.com/company/centricityresearch/  Contact Us:  Messenger: m.me/CentricityUSA  Phone: 888-737-7408 

What 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/centricityresearch/  Contact Us:  Messenger: m.me/CentricityUSA  Phone: 888-737-7408 

How 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.

When 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.

Let’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.

In 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 being free!  Learn more about the benefits of clinical trial participation for both physicians and patients! 

Do 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 maximize your marketing impact.

The 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.  

There 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 that.  

Dr. 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 please visit ACRPNET.org.

The 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, doesn't mean you shouldn't do it. You should do it because it's the right thing to do. If we have enough real-world evidence data that we could leverage to eliminate placebo arms, no matter how hard it is, we should do this. We should take on that challenge.

We'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 workers or frontline workers, you're in a situation where they could get the vaccine outside of the research trial.Do you un-blind that patient? Meaning do we find out if the patient got the vaccine or the placebo in the research trial, or not? Here are the ethical challenges. If I look at an individual patient who is 75 years old and has type two diabetes and she entered a research trial, and now she can qualify to get a known vaccine outside of a research trial from the health department. If

We 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 stair-step the amount of vaccine available to the planet. And, instantaneously, you've made a difference in rapidly being able to vaccinate more people, which is how we save lives. It's also how we reopen economies and get out of the mess that we're in. So I would say to you that the reason you should still consider a COVID vaccine trial, despite the fact that there are EU approved vaccines, is because of altruism - because it helps all of humanity, you'll get fantastic healthcare, and you'll also b

The 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 see that there was a community that had more transmission of COVID-19 than the other communities. And they were questioning why - was it a cultural thing? Was that community not doing social distancing? Were they not using masks? Was there a super spread or event? Was there a big party or event that happened in that community? And they couldn't find anything. And then they look looked at the genetic profile of the virus in that community. And that's how they uncovered that there's a mutatio

Pfizer 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?

The 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!

Dr. 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?

Pfizer 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! 

You'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 affecting minority populations more than other populations. It is impacting the African-American or black community more than it is the white community. It is impacting the Hispanic, Latino community more than it is the white community. You absolutely must have diverse patient populations in order to seek FDA approval.”