Agree with all, the Bril-OM test is so cheap and e
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Posted On: 08/11/2017 3:52:48 PM
Re: someconcerns #36618
Agree with all, the Bril-OM test is so cheap and easy to administer that they could easily do a Phase III without needing a partner. It's not like Bril-UP that involves endoscopies at beginning and end, and the resultant (high) costs thereof. And, of course, the fact that there is no real treatment for OM should make it easier to get patients in the clinical trial.
That said, I think it would be difficult to create a placebo for the OM trial that wasn't obviously a placebo. When someone's taking a pill, it's easy to give them a dummy pill. Likewise, with an injection, who can tell if it's the drug or saline?
But something you swish around in your mouth -- people are going to be making judgments based on taste and texture. I think you'd do better just to treat it as an epidemiological study -- how many people didn't get severe OM, as compared to the statistics for all head and neck cancer patients? Increasingly clinical trials are using these epidemiological studies, especially when it would be unethical to subject a patient to placebo in a clinical trial for something as dangerous, painful, and debilitating as OM.
That said, I think it would be difficult to create a placebo for the OM trial that wasn't obviously a placebo. When someone's taking a pill, it's easy to give them a dummy pill. Likewise, with an injection, who can tell if it's the drug or saline?
But something you swish around in your mouth -- people are going to be making judgments based on taste and texture. I think you'd do better just to treat it as an epidemiological study -- how many people didn't get severe OM, as compared to the statistics for all head and neck cancer patients? Increasingly clinical trials are using these epidemiological studies, especially when it would be unethical to subject a patient to placebo in a clinical trial for something as dangerous, painful, and debilitating as OM.
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