Our Safety Stats & Facts

Some people think that we inject our participants with drugs and "see what happens". This couldn't be further from the truth! A very high bar is set for investigational medication to advance to the clinical trial stage. By the time it's ready for a Phase 1 clinical trial, it has already passed:

• Laboratory and animal testing: The vast majority of experimental drugs never make it past this stage. Scientists spend years getting to know the medication through and through.
• Internal evaluation: Our own scientists evaluate the results of these earlier tests. We determine if the medication has sufficient potential for efficacy (will it work?) and safety. We follow the guidance of the Australian Therapeutic Goods Administration and international regulatory agencies like the FDA and EMA.
  
• Independent review: If a trial meets our requirements, it also needs to be approved by an independent Human Research Ethics Committee (HREC). They will evaluate the trial, and provide approval or suggest changes before it can be approved.

The goal of this process is to maximise the chance that the medication will be effective and minimise the risk. The results of the animal trials also allow us to have some expectation of what any effects might be, so we pay close attention to those too.

We have rejected studies where we did not feel comfortable with the risk level or had doubts about the potential efficacy of the medication. The safety of our participants is always our primary concern.

Our main safety concern is the potential for allergic/anaphylactic reactions, which can occur on rare occasions. These reactions respond well to immediate treatment, which is on hand in our clinic, as well as at the emergency rooms of the hospital precincts in which our clinics are located. We have trained staff at the ready if anything should happen. Over the last eight years, three people have had an anaphylactic reaction. All three were quickly treated and made a full recovery.

Some of the steps that we take to prepare for if something does go wrong:

• We employ dozens of medical staff who provide round-the-clock monitoring. We will also give you a number that you can call 24/7 to speak to a doctor if you have any concerns.
• Our clinics are embedded within hospital complexes (the Alfred in Melbourne and QIMR in Brisbane). We have a close working relationship with these hospitals and can call on their medical teams if there is an emergency.
• While trials are underway, their results are regularly reviewed by a safety review committee. If there are any concerns the trial is paused until further review or stopped entirely.

Because we are testing new medication, there is always the potential for side effects such as nausea, headaches, fatigue, and skin irritation around any patches or injection sites. If these occur, they will be closely monitored, and if necessary you will receive treatment for them.

Should there be a significant side effect, despite all of our efforts to prevent this, there is insurance in place to cover the cost of treatment for any injury or complication that has been independently determined to have occurred as a result of the study drug or a study procedure.

The initial dose level is determined based on the results of pre-clinical trials. This is orders of magnitude smaller than what was found safe in these pre-clinical trials. A key part of a clinical trial is understanding what is the minimum safe dose that will still have the desired effect.

Trials are split into groups, and we increase the dose level in incremental steps. Only once we are confident about the results of one dose level do we proceed with the next group.

Most of our trials also use a sentinel dosing schedule. This means that in each group we start with 2 people that are very closely monitored, one of whom receives a placebo. We only proceed with the rest of that group once we have reviewed the results of the sentinel participants.

If you want to do a clinical trial, you will first speak to one of our Recruitment staff over the phone. They will provide basic information about the clinical trial and check your eligibility.

If you are still interested, we will send you an email with the Participant Informed Consent Form (PICF) and set up a screening appointment. During that appointment, one of our doctors will go through the PICF with you. They will cover the study details, including the potential risks.

Information in the PICF includes:

• The goals of the study.
• Information about the study schedule and the procedures that will take place.
• The requirements for participants, e.g. abstaining from recreational drugs or smoking.
• The potential risks of participating in a study (including from the study drug and study procedures like blood draws).
• What information we collect and how we process it.
• What to do if you have questions, concerns, or complaints.

It's very important to us that you read and understand everything presented to you. We want you to be fully informed before you consent to the trial. That's why transparency is so important to us, and we are happy to answer all of your questions so you can make an informed decision. Click here for more information about the participant journey.

Consent is not a one-time checkbox but an ongoing process. Throughout your participation, you are always free to ask questions.

You can withdraw your consent at any time and stop your participation in the study. You will never be forced to do anything you do not feel comfortable with.

We do ask that you inform us if you decide to withdraw, so we can discuss any health risks or special requirements linked to withdrawing from the study.

The majority of our participants do not suffer any side effects, and those that do are usually minor and temporary. We do everything we can to make our clinical trials as safe as possible, but like with any medication, there is always some element of risk.

Risk is inherent in everything we do as a normal part of each day, from crossing the road to eating out. It would be dishonest to claim that there is no risk when participating in a clinical trial, but you can be assured that every precaution is taken to address the risks and monitor any potential concerns before they become a problem.

What we can guarantee is that we will:

• Spend significant time and effort to minimize the risk to you and other study participants.
• Provide you with all of the information you need to make informed decisions.
• Listen and directly address any concerns you have, before, during, and after the trial.

With every decision we make, participant safety is always our primary focus.

No. Not during a pandemic, not during an emergency, not ever.

Nucleus Network is completely independent from pharmaceutical manufacturers and developers. We have to abide by external ethics committees, government regulation and oversight, as well our own senses of professionalism and proper conduct.

The data and reports from our clinical trials are usually released for peer review in respected medical journals by the client once it passes Phase 1, and often the preliminary data is also released before the phase is completed. This means that other medical professionals (including competitors of ours and rival companies to the pharmaceutical company) can review the data and search for any irregularities or problems—and you can believe that there are many people scrutinising these results.

If the trial is unethical, the data fudged or even the way we report it is too confusing, Nucleus Network would soon find itself as a company that no client or participants would want to work with and no ethics group or government body would endorse.

So you can see, it's in everyone's best interests to ensure that participants are kept as safe as possible, as well as making sure that the results are a true reflection of the trial.