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 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 be paid for your participation. 

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 I look at an individual patient ethically, what should I do for her - unblind her? If she got the vaccine, you're cool. If she got a placebo, she needs to get a vaccine at the health department. 

Now let's look at all the patients that are in the research trial at the same time. If we say to all the patients, “we’ll unblind all of you so that you can get the vaccine”, we now create a situation where the trial is designed to fail because the blinding had a purpose in the first place. And if we now make a decision that makes the trial fail, that's unethical to the people that gave them of themselves to be in the trial in the first place, because they entered a trial based upon the assumption that it's going to produce a scientifically worthwhile result. And if we do something that violates that, well, that was unethical to the people that volunteered in the first place. 

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 mutation. There's a virus floating around in that community that's now a little bit different. And now that virus is starting to travel around the world. It's now in the US.  That will never stop. Mutation will always happen. Don't worry about that. Nothing we can do about that, that will happen. Not a big deal. The mutation is most likely not going to have any impact on the efficacy of our vaccines, just in terms of probabilities that mutation most likely will have nothing to do with the efficacy of our vaccines. And the other virus is going to continue to travel around the world. And we don't know which one is going to become the predominant strain. So keep getting the vaccine - don't stop vaccinate yourself. 

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.”