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Navigating human research ethics


Amplia recently announced that it had received ethics approval for its upcoming Phase 2 trial of AMP945 in first-line pancreatic patients. We spoke with Nic Kruger, Amplia’s Director of Clinical Operations, about the process involved in gaining ethics approval, and how this announcement is a significant milestone requirement for the Company ahead of this trial. 

In Australia, the Therapeutic GoodsAct 1989 requires a Human Research Ethics Committee to review and monitor all clinical trials of unregistered therapeutic goods. This is an independent process, conducted by an ethics committee registered with the National Health and Medical Research Council (NHMRC) - the governing body which oversees medical research in Australia.

“The human ethics process is a vital component of conducting medical research in Australia - it exists to ensure that human clinical trials have scientific integrity, and that the rights and wellbeing of people who participate in the trial are being protected,” explained Nic. 

According to the NHMRC’s National Statement on Ethical Conduct in Human Research, a Human Research Ethics Committee comprises at least eight members.

“The composition of the ethics committee is mandated to ensure a broad review, with each committee required to include a Chairman; two lay people - one man and one women; a clinical expert; a person who performs a pastoral care role in a community; a lawyer, and two people with current research expertise that is relevant to the research proposal.”

So what does the ethics process look like, and is it a difficult requirement? 

“It can be complex, but not difficult,” Nic explained. “Essentially, Amplia works closely with each of the clinical trial sites, who will be conducting the trials, to bring together all the necessary documentation required by the Ethics Committee to satisfy them that our clinical protocols are  ethical and scientifically sound. 

“The ethics submission is the point at which we need to consolidate all of the work we’ve done to date, and for the sites to submit it for scrutiny by the committee. It outlines what we’re going to do, and how we’re going to do it. It includes providing  background information on the drug, the science we’ve collated through preclinical studies, as well as the data from our earlier clinical studies. 

“It also includes reviewing any patient communications, any recruitment materials, and any consent forms that will be given to trial participants, to ensure that they are written in a way that is clear and unambiguous, so that they can participate in the study with a complete and thorough understanding of what it entails.”

While it may sound like an onerous task, Nic said Amplia’s experienced team, and rigorous approach to record-keeping, combined with the expertise of the trial sites means that the process is streamlined. 

“The ethics submission, in itself, isn’t difficult, but it is a critical milestone. It’s a stage gate - if you don’t meet the requirements of the ethics process, then the work comes to a halt.  The hard work is all the stuff that’s been done previously to justify moving forward with the clinical trial. It’s the years of work to make sure you’ve done the right animal studies, and the right toxicology studies, and all the right things to make sure that participants are protected when they take part in your study.”

So with ethics clearance received for sites in NSW and Victoria, what comes next? 

According to Amplia’s CEO and Managing Director Dr John Lambert, it means that Amplia will soon be able to initiate recruitment into its Phase 2 trial. 

“Achieving Human Reseach Ethics Committee approval means that Amplia now has a green light to move ahead with finalising site approvals and recruiting patients into the first phase of our trial, and we expect the first patient in the trial to be dosed before the end of the quarter,” John said.

“It’s a great tribute to everyone involved with the development of AMP945 to finally be able to initiate this important clinical trial, and we are excited to be able to share the results as they emerge.”