By Momentum Clinical Research CEO, Joshua Stent and Holdsworth House Research Director, A/Prof Mark Bloch
Clinical trials are a crucial part of the drug development process, yet more than half (55%)[i] of global trials are terminated due to not being able to recruit sufficient participants and four in five (80%) are forced to add new sites to a study after failing to enrol sufficient participants[ii].
Because of this, potentially life-changing medicines and treatments are not realising their potential.
The evolution of any drug is both a lengthy and expensive process for pharmaceutical companies and biotech organisations. The high-stakes process is also coupled with the fact that the majority (90%) of drugs fail the development process[iii].
With the clinical trial journey taking between 10-15 years to complete, and the average cost being over US$2 billion for each drug to be approved and become fit for purpose2, recruitment of trial participants shouldn’t have to be another concern for those hoping to make a difference in the world.
To prevent biotechs and pharmaceutical companies from having to forfeit their study early, Momentum Clinical Research have shared their advice for what clinical trial sponsors should look out for when looking for research partners:
- A proven track record of reaching patient recruitment targets.
- Streamlined processes and a dedicated point of contact.
- Sites located in areas with a diverse population.
- Guaranteed study timelines.
- Clinical site organisations that meet the FDA’s standards of accuracy, reliability and patient safety.
If sponsors are able to tick off the above when selecting sites to conduct their trials as well as partnering with a reputable clinical research organisation, they should be confident that a lack of patient recruitment won’t be a barrier. Sponsors need to have reassurance they are in good hands when they’ve already invested so much into the process.
Momentum Clinical Research was formed through the merging of New Zealand’s P3 Research and Australia’s AusTrials and Holdsworth House, providing a solution for biotechs and pharmaceutical companies who require guaranteed patient recruitment numbers. We’ve been able to provide this due to years of experience in recruitment marketing and patient engagement and support strategies. This experience has enabled us to not only recruit the necessary number of trial participants, but retain them over the duration of the trial, which can sometimes span over several years. This method has resulted in us meeting and exceeding the required numbers for the majority of clinical trials.
Across our 13 Trans-Tasman sites, we’ve conducted more than 200 Phase Ib-IV clinical trials – which is when medicines are being tested for safety and efficacy and we’re looking to prove a drug’s effectiveness. Unfortunately, Australia and New Zealand are sometimes overlooked by overseas sponsors when allocating sites to conduct their trials. Yet the two countries offer great opportunity as they have multiple benefits in relation to the diversity of participants meaning a larger number can be utilised over a shorter period of time.
A few of the reasons why the Trans-Tasman shouldn’t be overlooked by overseas sponsors include:
- High standards of medical care.
- International Good Clinical Practice (GCP) standards of conduct.
- Clinical trial data that is recognised by US Food and Drug Administration and European Medicines Agency.
- Diverse patient populations.
- Tax incentives for overseas sponsors investing in research across Australia and New Zealand[iv],[v].
Not only have our sites passed the rigorous and world-leading standards of the FDA after a successful audit in February 2024, but our in-house recruitment team and database of over 50,000 potential participants, has enabled us to run high quality and efficient trials. This, in turn, has enabled sponsors to bring drugs to the market faster, in an ethical way.
As a solution to the global recruitment challenges faces during the clinical trial process, sponsors should consider hosting their trials across Australia and New Zealand, and take advantage of the multicultural participant populations, tax incentives and globally recognised regulatory systems on offer.
By doing this, overseas sponsors will be confident that patient recruitment won’t be a barrier in their clinical trial journey, which will result in them being able to make a difference sooner.
References:
[i] https://www.scirp.org/journal/paperinformation?paperid=128354
[ii] https://www.scirp.org/journal/paperinformation?paperid=128354
[iii] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9293739/
[iv] https://www.australianclinicaltrials.gov.au/industry-and-sponsors/why-conduct-in-australia
[v] https://www.medsafe.govt.nz/regulatory/Guideline/GRTPNZ/Part11.pdf
