COVID Showed How Trials for New Drugs Could Be Faster and Better

nearly entirely virtual scientific trial to compare warfarin [which prevents blood clots] with another oral anticoagulant, apixaban, for clients with a certain kind of prosthetic aortic valve. People offer their consent to get involved over the phone. The research study drug is shipped straight to the client. As long as they are succeeding, there is no factor for participants to come on-site. Everything is done over the phone. It’s going great.

Should virtual trials continue when we are no longer worried about participants capturing COVID?

Yes, certainly. It empowers involvement. We’ve put in location too many barriers. If people wish to take part in trials, we must make it simple for them. Our IRB [institutional review board] and our institutional legal representatives aren’t really comfy with me hiring people who have no relationship with the Duke health system. The concern is: “What if something fails? Where would they go?” Well, they ‘d go to their medical professional or healthcare facility close by.

So much of scientific research study is built around the investigative site– a website agreement, the website IRB, and the site medical records that are used as documents for the research study check out. This new paradigm [of remote trials] starts to question all of that.

Do you see other ways to make research much better for participants?

If we could make it easier and less duplicative to be in trials, we would get more involvement. For example, do we actually need a whole separate medical research study labor force? My medical nurses do not usually think research is part of their jobs, and my research study planners don’t believe medical care becomes part of their jobs. Why don’t we attempt to make research study and scientific care more seamless and integrated so participation in research study is less of a concern on the patients and the entire system?

What other modifications could make research study more effective and less burdensome?

One is to reform IRBs. I run big cardiology scientific trials, partnering with industry to study drugs that are regulated by the FDA and other regulatory authorities. There was one trial where we had more than 1,000 scientific sites in 37 countries. Every site had its own IRB, so you had 1,000 IRBs reviewing this procedure. Let’s say each IRB has 10 individuals, that’s 10,000 individuals evaluating this protocol. It’s currently been reviewed and settled by the sponsors, a scholastic steering committee, and the FDA and other regulators. The regional IRBs can’t alter the procedure. All they can do is decide to get involved or not and to make minor modifications to the regional permission kinds. What is the worth of having 1,000 IRBs review the procedure?

Every IRB (appropriately) charges money to evaluate a protocol; they desire $1,000 or $2,000, so that’s a lot of cash and a great deal of time. All these smart reviewers have viewpoints, and those viewpoints need to be dealt with. Let’s state you might really get all but one IRB for a big multicenter medical trial. That’s a big opportunity for effectiveness.

Would more effectiveness maximize resources to pursue extra research study?

Yes, however the key to this transformation is the pursuit of quality and performance together. Lots of trials that are conducted are too little to answer essential questions.

Are you enthusiastic that changes in trials will endure after the pandemic?

Clinical research study is a high-stakes, highly controlled enterprise, and modification in a system like this is difficult. They do all the functional things that is needed if you desire to get 1,000 IRB evaluates completed.

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