Replies to post #331367 on Innovation Pharmaceuticals Inc (IPIX)

[cybermich]

The Company is now incorporating this feedback and finalizing the trial protocol for its planned Phase 2, randomized, double-blind, placebo-controlled...

Then you say..

The most highly respected contributors here have a duty to also be the most careful.


1. is now incorporating this feedback and finalizing the trial protocol indicates that the trial design is not finalized yet:) so your scathing criticism might be premature:) if you want to get really technical and considering you are calling people out I would use your own lofty standards on yourself first.

2. Using some kind of standard of care (instead of nothing) would make logical sense - at least something for both Leo and the FDA to consider - since there is an ethical/moral line to consider when treating somebody with a known/potentially deadly disease.

Can I a get a touche?:)

[bradfordbros]

I know I’ve butted in but are you suggesting suppress the news or something like it?

[farrell90]

We will see what the FDA allows. Since Remdesivir has been approved as a Covid19 treatment in can be used as an alternative treatment insted of a placebo. Many clinical trials will use the approved treatment as an alternative to placebo when a drug in the same class is studied for serious illnesses.

Many question the ethics of using a placebo when studying a life threatening illness.

"But it’s not so easy to determine how those participants should—and shouldn’t—receive treatment. “Most people believe a placebo is necessary for a gold-standard trial,” says Li. In the strictest sense, a placebo would be nothing more than a sugar pill, as this allows scientists to determine whether the treatment under study is actively helping people.

The ethics of a true placebo don’t pan out in a pandemic situation: When patients are suffering from a serious medical condition, doctors use “standard care” as the placebo instead. “Since most new drugs don’t work or are harmful, you are not clearly worse off by being randomized to a placebo on top of usual care,” says Alex John London, director of the Center for Ethics and Policy at Carnegie Mellon University, who has written on the ethics of clinical research during public health emergencies.

For Covid-19, standard care is largely supportive. The lopinavir–ritonavir study tested the drug against giving patients oxygen, ventilation, antibiotics, and support for pumping blood, kidney function, and blood pressure as needed. Researchers can also run “adaptive trials,” meaning they test various drugs against each other, as well as as combining the drugs to see if that increases
effectiveness. The format allows for certain drug treatments to be abandoned more quickly if it seems to be ineffective, and also allow more patients to have access to potentially effective treatments. But it can take longer to prove that a drug is effective when compared to another drug, as opposed to when it’s compared to placebo alone."

https://qz.com/1826431/the-ethics-of-clinical-trials-for-coronavirus-treatments/

GLTA Farrel