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

practically completely virtual medical trial to compare warfarin [which prevents blood clots] with another oral anticoagulant, apixaban, for patients with a certain kind of prosthetic aortic valve. Individuals give their grant get involved over the phone. The study drug is shipped directly to the client. As long as they are succeeding, there is no reason for participants to come on-site. Everything is done over the phone. It’s going fantastic.

Should virtual trials continue when we are no longer stressed over participants capturing COVID?

Yes, certainly. If people want to get involved in trials, we must make it easy for them.

So much of medical research study is built around the investigative website– a website contract, the website IRB, and the site medical records that are utilized as documentation for the research see. This new paradigm [of remote trials] begins to question all of that.

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

If we might make it simpler and less duplicative to be in trials, we would get more involvement. For instance, do we truly require an entire different medical research study workforce? My medical nurses do not normally think research study becomes part of their jobs, and my research study planners don’t think medical care belongs to their tasks. Why don’t we attempt to make research study and medical care more smooth and incorporated so participation in research study is less of a burden on the patients and the entire system?

What other changes could make research more effective and less challenging?

One is to reform IRBs. I run big cardiology scientific trials, partnering with market to study drugs that are managed by the FDA and other regulatory authorities. There was one trial where we had more than 1,000 scientific sites in 37 nations. 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 reviewing this procedure. It’s already been reviewed and finalized by the sponsors, an academic steering committee, and the FDA and other regulators. The regional IRBs can’t change the protocol. All they can do is choose to get involved or not and to make minor changes to the local approval kinds. What is the worth of having 1,000 IRBs review the protocol?

Every IRB (appropriately) charges cash to review a protocol; they desire $1,000 or $2,000, so that’s a lot of cash and a lot of time.

Would more efficiency maximize resources to pursue additional research?

Yes, but the key to this change is the pursuit of quality and performance together. Many trials that are performed are too little to address important questions.

Are you hopeful that changes in trials will sustain after the pandemic?

Scientific research is a high-stakes, highly managed business, and change in a system like this is tough. They do all the functional stuff that is needed if you desire to get 1,000 IRB reviews finished.

Read more about the coronavirus break out from Scientific American here And check out protection from our global network of publications here