11 May

ANZ Region Rescues Stalled Global Clinical Trials

Randomized, controlled trials are considered the gold standard for evaluating the safety and efficacy of potential new medicines and therapies, as they provide a rigorous and unbiased way to compare treatments to placebo or standard care.

These trials can be extremely complex and are often delayed due to factors such as regulatory approvals and patient recruitment and retention. Furthermore, some trials such as studies of seasonal flu vaccines, need to be conducted during a particular season to recruit the target population.

When a clinical trial is interrupted, altered, postponed, or even cancelled, it can have significant financial implications for the sponsor, and the human cost even more significant. Delayed or failed trials means patients will wait longer for new, potentially life-saving treatments. 

An increasing number of biotechs have been leveraging the benefits provided by the ANZ region to conduct rescue studies and extend seasonal clinical trials.

Rescue Studies

The success of any clinical trial relies heavily on patient recruitment and retention. It is widely accepted that almost half of all delays in clinical trials are a result of issues related to patient recruitment and retention. 

Patient recruitment holds great significance in the successful completion of a clinical trial. It is imperative to recruit the targeted patient population to obtain high-quality clinical data that meets the standards of international regulatory bodies like the FDA and EMA. Failure to meet recruitment targets or failure to gather a diverse population required can compromise the quality of clinical data, leading to potential rejection of the data by the FDA or EMA.

The ANZ region has been known for its diverse population and proven patient recruitment and retention rates, rescuing stalled global trials by providing a streamlined process that can get studies started quickly.

Compared to the northern hemisphere, Australian and New Zealand populations are more willing to take part in clinical trials. This willingness of our local populations to participate in clinical trials is offering a lifeline for CROs having issues with patient recruitment to prevent delays in completing their studies, or even to ”rescue” these trials.  

Australia and New Zealand have one of the fastest study start-up timelines. The streamlined ethics and regulatory processes make it easy to get rescue studies up and running while producing high-quality data. Having these processes make it easier and faster for sponsors to get their studies approved and started which ultimately, leads to faster trial completion. The rapid study start-up timelines make Australia and New Zealand a cost-effective region for sponsors, making it a preferred location to conduct high-quality clinical trials.

PharmaSols’ ability to overachieve patient recruitment targets and achieve rapid study start-up timelines has been shown in recent studies. We were able to have a final recruitment number of 206% of the initial target in just 26 days! Additionally, PharmaSols also achieved a 35-day start-up timeline for a recent study.

Seasonal trials all year 

There are many complexities associated with running a clinical trial where a seasonal indication is the target or could impact the trial itself. 

Respiratory illnesses, influenza, and allergies are all related to seasonal conditions and are best studied in the corresponding seasons. This puts pressure on the timeframes for regulatory approvals and patient recruitment. 

Some studies find it challenging to recruit enough participants throughout a long-term study, let alone during the shortened timeframe of a seasonal trial. The complexities surrounding patient recruitment quickly raises the risk that the ideal season will end before the trial can get underway. 

Fortunately, recruitment and retention struggles need not prove fatal for seasonal studies. The southern hemisphere provides a haven for these studies, allowing them to continue running, and even resolving their recruitment issues. 

Because the northern and southern hemispheres experience opposite seasons, northern hemisphere sponsors can run trials in Australia and New Zealand that would otherwise be ‘out of season’.

Sponsors also have the option of extending their seasonal trials by moving them to Australia and New Zealand at the end of the northern hemisphere winter. Effectively, these trials can run all year round. 

PharmaSols

PharmaSols is uniquely positioned in Australia and New Zealand, one of the world’s most trusted and rapidly growing clinical trial regions. With over 20 years of experience in this region and a team of dedicated experts, we support sponsors achieve their patient recruitment targets and collecting high-quality data from this region. 

In addition to this, PharmaSols takes a creative problem-solving approach, has a trusted network of experts, and maintains a people-driven attitude, so you can be confident that your trial will remain on track and meet its targets.