15 Oct

ANZ Region – place to extend seasonal clinical trials and rescue studies

The timelines for clinical trials are often disrupted or face challenges that risk their success for various reasons. However, some types of trials rely on seasons, meaning they are racing to meet nature’s own timeline.

So, what happens to a study if it doesn’t meet the deadline?

‘Out of season trials’

Conditions like respiratory illnesses, influenza, or allergies are all related to seasonal conditions and are best studied within the corresponding season.

With New Zealand and Australia’s seasons opposing to the Northern hemisphere, sponsors have the opportunity to run trials that would otherwise be ‘out of season’.

Sponsors also have the option of extending their seasonal trials. The end of the winter season in the Northern hemisphere means trials can continue to run by moving to the Southern hemisphere, where winter will just be starting. Effectively, these trials can run all year-round.

Rescue studies

All trials run into issues, often resulting in significant delays. These delays can have substantial financial and human impacts. It’s typical to see trial timelines get interrupted by issues around patient recruitment and retention & lengthy ethics and regulatory timelines.

The ANZ region provides solutions to these issues that typically cause significant delays for clinical trials. These solutions include, streamlined ethics and regulatory timelines, increased awareness and participation in clinical trials, and set up of high quality research capabilities.

Compared to the Northern hemisphere, Australian and New Zealand populations are more willing to participate in clinical trials. Both Governments are heavily supportive of clinical research initiatives and actively encourage the conduct of clinical trials, an attitude which is reflected in the population.

Trial stats from ANZCTR show that between 2015 and 2020, patient recruitment exceeded expectations, resulting in 103% retention of patients [1].

In addition to being highly informed and willing participants, there are relatively low transmission rates of COVID-19, particularly in New Zealand. Even with less risk of exposure to the virus, the New Zealand Australian regions are set up for telehealth capabilities and are equipped with virtual trial technologies. These virtual trial strategies were adopted early into the pandemic and have been widely embraced in this region.

Seasonal differences also present a unique opportunity for trials to be ‘rescued’.

While it is often a struggle to attract trial participants, some studies also find it challenging to find suitable patients during the trial’s start-up period. These interruptions can result in considerable loss of vital data, creating a huge financial burden and ultimately risking the success of the trial. If these kinds of issues and interruptions arise for seasonal trials, there’s a chance the ideal season will end before the trial can resolve its problems, putting an end to the entire study.

Luckily, recruitment and retention struggles do not have to hinder seasonal studies completely. The Southern hemisphere stands as a rescue haven for these studies, allowing them to continue running and even resolving their participant issues.

Seasonal studies racing against the clock trying to resolve participant issues, whether they be pandemic related or not, have the opportunity to continue in the Southern hemisphere.

PharmaSols

PharmaSols unique location allows us to leverage the benefits of opposing seasons, world-class research hubs, a willing participant population, and low transmissions of COVID-19.

With over 20 years of experience in this region, we have established a trusted network of experts and a creative approach to problem-solving, PharmaSols is the ideal CRO running or rescuing seasonal trials.

Sources:

[1] Australia New Zealand Clinical Trials Register (2015-2020) Commercial Trials