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

nearly completely virtual medical trial to compare warfarin [which prevents blood clots] with another oral anticoagulant, apixaban, for patients with a certain type of prosthetic aortic valve. Individuals offer their consent to take part over the phone. The study drug is shipped straight to the client. As long as they are succeeding, there is no reason for participants to come on-site. Whatever is done over the phone. It’s going fantastic.

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

Yes, absolutely. If people desire to participate in trials, we need to make it easy for them.

So much of clinical research study is developed around the investigative website– a site agreement, the website IRB, and the website medical records that are utilized as documents for the research study go to. This brand-new paradigm [of remote trials] begins to question all of that.

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

If we might make it much easier and less duplicative to be in trials, we would get more involvement. Do we actually need a whole separate scientific research labor force? My clinical nurses don’t usually believe research study belongs to their jobs, and my research organizers do not believe clinical care belongs to their jobs. Why don’t we attempt to make research and medical care more smooth and incorporated so involvement in research study is less of a concern on the patients and the entire system?

What other modifications could make research more efficient and less difficult?

One is to reform IRBs. There was one trial where we had more than 1,000 scientific websites in 37 nations.

Every IRB (appropriately) charges cash to review a protocol; they want $1,000 or $2,000, so that’s a lot of cash and a great deal of time. All these smart customers have viewpoints, and those opinions need to be dealt with. Let’s state you might really get all but one IRB for a large multicenter medical trial. That’s a substantial chance for efficiency.

Would more performance free up resources to pursue extra research?

Yes, but the secret to this change is the pursuit of quality and efficiency together. Lots of trials that are performed are too little to respond to crucial concerns.

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

Scientific research is a high-stakes, extremely managed business, and modification in a system like this is tough. There are people who would lose, people whose jobs are mainly doing what we are discussing as inefficiencies. There is a CRO [contract research organization] market, and much of their work would go away. They do all the functional things that is needed if you wish to get 1,000 IRB examines finished. COVID has highlighted the need for change and jump-started us some, however I believe there’s a threat that we wander back when the pandemic ends.

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