While COVID-19 rates in the US, Europe and other parts of the world are higher than those leaders might like, New Zealand’s infection and fatality numbers have been enviably low. The country’s citizens are able to attend concerts and rugby matches without masks, and businesses can operate without the restrictions that make travel and commerce challenging in other parts of the world.
For those reasons, Kiwi contract research organizations (CROs) like Pharmaceutical Solutions (PSL) are enjoying increased interest in their operations. Outsourcing-Pharma (OSP) recently spoke with managing director Jacquie Palmer (JP) about the phenomenon, and what it could mean for the future of clinical research in the region.
OSP: Could you please tell us about the evolution of the clinical trial industry in New Zealand—how has it grown and changed over the years?
JP: In terms of size, the clinical trials industry in New Zealand has been relatively stable over the past five years; more recently, we are seeing a growing interest in NZ for early phase studies, particularly in the therapeutic areas of oncology, neurological and infectious diseases. New Zealand has one of the highest rates of asthma and respiratory disease rates in the world and we would like to see more global trials coming into this region for these therapeutic areas, where we have both patients and strong key opinion leaders.
New Zealand has a strong history of conducting successful ‘rescue studies’, where recruitment has been difficult internationally and new geographic regions must be considered. This is common with seasonal studies like flu, where our southern hemisphere effectively extends the northern hemisphere winter and therefore the patient recruitment period is extended.
OSP: Please share how the COVID-19 pandemic initially impacted NZ and the trial landscape in the country, especially in the months from the time it hit to now.
JP: Clinical trials in New Zealand are viewed as essential services by government, which has meant that sites and CROs have been able to work together very closely since Covid-19 lockdowns began. Sites in New Zealand moved quickly to introduce new secure document exchanges to facilitate remote monitoring, and we sought to understand each site’s different status and approach to remote monitoring.
To ensure trial continuity, Pharmaceutical Solutions has adopted an agile response. Are the sites remote monitoring capable and are they allowing for patient visits or on-site monitoring visits? As we move up and down alert levels, has this approach changed?
The strength of our relationships with sites has meant that Pharmaceutical Solutions has been kept up to date with every site’s monitoring status and we have easily transitioned across to remote monitoring.
Just two days after the first lockdown began in New Zealand, our team were remote monitoring at sites that just two days previously, weren’t remote capable. We are really proud of the speed and can-do attitude shown by both our sites and our CRAs that made this happen.
During the initial outbreak of COVID-19, Pharmaceutical Solutions saw some existing studies and new startups going on hold both globally and in New Zealand. Now, we are seeing a growing interest in New Zealand. With comparatively low rates of community transmission, NZ is now being viewed as a safe option for clinical trials where trial continuity is assured.
In other countries, COVID-19 deters patients from taking part in clinical trials and strains health systems which are treating those afflicted by the virus. As a result of these factors, companies are looking to other geographic areas to deliver clinical trials.
OSP: What about NZ makes it an appealing location for clinical trials?
JP: Australia and New Zealand are home to some of the world’s best researchers, health professionals and high-quality clinical research sites. With stable socio-political environments and an international reputation for quality and integrity, this region can be trusted to deliver accelerated, cost-effective, quality clinical trials; New Zealand in particular provides global sponsors with one of the fastest regulatory approval environments in the world.
Our network of partners has proven that accelerated ethics and regulatory frameworks can deliver start-up in 35 days, and we consistently deliver rapid recruitment and quality results superior to many global CROs.
OSP: Please tell us about the situation at Auckland Clinical Studies—I understand the site is at full capacity.
JP: Auckland Clinical Studies is a Phase I clinical trial site, and in response to increased interest in New Zealand, they are currently at full capacity. However, Pharmaceutical Solutions works with a number of other Phase I units in New Zealand, and there is industry capacity across all phases as the clinical trials industry rebounds from COVID-19 and positions itself for growth.
OSP: Could you please tell us about Pharmaceutical Solutions—who you are, how you’ve grown, and what sets you apart (in addition to being the only NZ-owned CRO)?
JP: Pharmaceutical Solutions is considered one of the leading private CROs in the Australian and New Zealand region. We provide full-service clinical research and regulatory/ethics management for global and local clients, from study start-up, through to trial completion, for all phases of clinical trials.
In the past year, our work has doubled off repeat business from clients. We’re proud to say that after organisations try out New Zealand and PSL, they come back and work with us again.
Pharmaceutical Solutions strives to continuously deliver clinical trials to the highest standards. A can-do attitude and strong relationships drive our business to consistently deliver what sometimes seems like the impossible. We all knuckle down and get on with it, even when things get tough.
OSP: How are you working to attract new and transitioning trials to NZ? How can you help new and ongoing trials make that transition, and make it smooth as possible?
JP: While travel restrictions are in place, we cannot attend the traditional tradeshows to promote New Zealand globally; and PSL, like many businesses, has increased our digital marketing presence. We are endeavouring to get the message out that NZ and PSL can help overseas companies looking to conduct clinical studies in a region where continuity is assured.
As we look ahead and collectively continue to navigate COVID-19, we recognise that globally we are all still in the midst of very uncertain times. The world needs quality research now more than ever and it is a privilege to be part of an industry that is today more vital than it has ever been.
PSL’s depth of experience in this region and NZ’s strong relatively COVID-19 free uniquely positions us to be able to support the global clinical trials industry.
OSP: Do you have any examples you would be willing to share of trials that have successfully launched in or transitioned to NZ?
JP: In the last three weeks, Pharmaceutical Solutions has seen three new study starts from three new clients that are new to this region. All three were unable to start studies in other regions due to the impact of COVID-19.
Clinical trials are complex, and they really do need a team of local experts to ensure the success of a trial. We look forward to forging a strong, ongoing relationship with these new clients as we support their study and assist them in enjoying the benefits of world-class clinical research capabilities and health infrastructure of this region.