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

practically totally virtual clinical trial to compare warfarin [which prevents blood clots] with another oral anticoagulant, apixaban, for patients with a particular type of prosthetic aortic valve. The study drug is delivered directly to the patient.

Should virtual trials continue when we are no longer fretted about participants catching COVID?

Yes, definitely. If individuals want to take part in trials, we ought to make it easy for them.

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

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

If we might make it easier and less duplicative to be in trials, we would get more participation. For example, do we truly need a whole different scientific research study labor force? My clinical nurses do not generally believe research study is part of their jobs, and my research study coordinators do not think medical care is part of their jobs. Why don’t we try to make research and medical care more smooth and integrated so involvement in research is less of a problem on the patients and the entire system?

What other modifications could make research study more efficient and less challenging?

One is to reform IRBs. I run big cardiology scientific trials, partnering with industry 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 countries. Every website had its own IRB, so you had 1,000 IRBs reviewing this protocol. Let’s state each IRB has 10 individuals, that’s 10,000 people reviewing this protocol. It’s currently been evaluated and settled by the sponsors, an academic steering committee, and the FDA and other regulators. The local IRBs can’t change the protocol. All they can do is choose to take part or not and to make small changes to the local permission forms. So what is the value of having 1,000 IRBs evaluate the protocol?

Every IRB (properly) charges money to review a procedure; they want $1,000 or $2,000, so that’s a lot of cash and a lot of time.

Would more efficiency free up resources to pursue additional research study?

Yes, however the secret to this improvement is the pursuit of quality and efficiency together. Both truly matter. Because of our cumbersome, inefficient processes and the time, workforce and other resources they demand, we have too few medical trials. Numerous trials that are conducted are too small to address important concerns. If we enhance research study infrastructure, we might accomplish a lot more to move medical science and patient care forward.

Are you hopeful that modifications in trials will endure after the pandemic?

Clinical research is a high-stakes, extremely managed business, and modification in a system like this is difficult. They do all the operational stuff that is needed if you desire to get 1,000 IRB evaluates completed.

Find Out More about the coronavirus break out from Scientific American here And read protection from our worldwide network of publications here