Dr Ron Eccles on Measuring the Blinding That Happens in Chronic Cough Therapy Trials

Most adverse events in trials of adenosine triphosphate (ATP) blockers for chronic cough are related to taste, which may inadvertently cause the studies to become unblinded to patients, and a way of measuring this to know the extent of the problem is needed, said Ron Eccles, BSc, PhD, DSc, emeritus professor at Cardiff University.

Most adverse events in trials of adenosine triphosphate (ATP) blockers for chronic cough are related to taste, which may inadvertently cause the studies to become unblinded to patients, and a way of measuring this to know the extent of the problem is needed, said Ron Eccles, BSc, PhD, DSc, emeritus professor at Cardiff University.

Transcript

How are companies developing these therapies determining how effective these therapies actually are in clinical trials?

In order to determine the efficacy of these medicines in clinical trials, you really need to know how unblinded the studies are. We know that in some trials, the highest doses of these ATP antagonists have caused 80% adverse events related to taste. And the investigators have said this may be unblinding the studies. It's not maybe I think—definitely they're becoming unblinded. So I think what we should do is try and measure the blinding. There should be measures put in into the study as at the end of the study, or during the study, what are you being treated with? And if the study is unblinded then we will know it's unblind. Companies are fighting shy of this. They don't want to torpedo their own clinical trials. They don't want to do it. But in science, we want to determine the truth. The truth will get out eventually. So I think we really do need to assess blinding in these clinical trials.