Parkinson's Disease (PD) is one of the fastest growing neurological disorders. With over 10 million people suffering from this disease worldwide, it has become a focus for the clinical research industry. As a globally prevalent disease, governments and companies all over the world have pooled resources to aid in PD research.

Within Australia, approximately 150,000 to 200,000 people have been diagnosed with PD, and it is estimated to cost the Australian economy roughly $8 billion per year. It is estimated 10 - 20% of people have Young Onset Parkinson's, meaning they were diagnosed between 20 and 50 years old¹. There is currently no cure for PD and further research is required into its causes and treatment.

Parkinson’s Disease Clinical Trials - Why Australia?

Australia boasts a robust healthcare system with world-class medical facilities and skilled healthcare professionals. There are a number of specialised clinical trial sites focusing on neurology research all around Australia, with experienced researchers conducting innovative clinical trials. High-quality care and monitoring for participants with PD is provided at these sites. 

Australia's multicultural society contributes to a diverse patient population, offering researchers access to a broad range of participant demographics for clinical trials. This diversity enhances the generalisability of study findings globally and enables researchers to explore potential variations in treatment responses across different demographic groups.

Australia has stringent ethical and regulatory standards governing clinical research, ensuring the safety and rights of participants. The Therapeutic Goods Administration (TGA) and Human Research Ethics Committees (HRECs) oversee the approval and ethical conduct of clinical trials, providing assurance to participants and Sponsors alike. The favourable regulatory environment in Australia is streamlined to support cost-effective and efficient clinical trials.  

Australia has developed an efficient governance framework, and introduced enticing rewards. The government has created the Research and Development cashback for international companies running their trials in Australia, giving up to 43.5% cashback. For the past 10 years the Australian government-run Medical Research Future Fund (MRFF) has given roughly $200 million per year to fund domestic neurological research in both public and private sectors². 

Datapharm Australia continues to build strong relationships with key clinical trial sites, further strengthening their Parkinson's and Neurological Disease Clinical Trial Alliance. Using AustralianClinicalTrials.com, a Datapharm Australia initiative, it is now easier than ever to find and contact these sites. Some of these sites include Southern Neurology, NeuRA, Central Coast Neurosciences, The Brain and Mind Centre, and more. Further information on these sites can be found on their trial site pages.

Collectively, these factors make Australia an attractive destination for conducting PD trials, enabling Sponsors to accelerate their research pipelines. 

Study Considerations and Guidelines

Leading regulatory authorities, including the FDA³ and EMA⁴, have released draft guidelines for running clinical trials in specific therapeutic areas. Recently the EMA released guidance addressing projects for PD. It includes recommendations for patient inclusion/exclusion and overall trial design. PD expresses similar symptoms to other neurological disorders, potentially leading to participants with other disorders entering PD clinical trials. It is therefore important for the study to differentiate PD from other diseases and include carefully selected inclusion/exclusion criteria^3,4,5. 

In addition, other key areas to consider when designing PD trials include the length of disease progression, and the variability of symptoms. Familiarity with the guidelines provided by the major regulatory authorities across the globe is important, as trials endpoints are always changing, and need to be adapted in order to have the best chance of approval. 

Recruitment Methods and Challenges

PD clinical trials are often lengthy, and with this comes challenges in  recruitment and retention. At Datapharm Australia we have experience assisting sites and Sponsors in recruitment and retention. Below are some tips we have found to be useful in the recruitment process:

• Use of advertising / awareness campaigns: through social media, AustralianClinicalTrials.com, partnering with GPs and radio advertisements.
• Number of Sites: utilising a variety of sites in different locations to enrol a diverse study population and to ensure recruitment requirements can be met. Competitive recruitment can be a great tool for boosting recruitment timelines.

• Engaging with patient support groups: to not only assist in participant recruitment but also retention. Advertising directly to the target study population can assist with recruitment numbers.
• Engaging with study groups to improve design: by engaging with the target study population and allowing for feedback to be provided, future studies can be designed with the needs and preferences of the target population in mind, increasing both enrollment and retention.

Please reach out to Datapharm Australia Clinical Trial Specialists if you would like support in designing or running your PD or other Neurological clinical trial. Datapharm Australia can also help to determine participant sample sizes when designing your PD study. 

References

1. Statistics (2024) Parkinson’s Australia. Available at: https://www.parkinsons.org.au/statistics/ (Accessed: 27 March 2024). 
2. Research funding statistics and data (no date) NHMRC. Available at: https://www.nhmrc.gov.au/funding/data-research/research-funding-statistics-and-data (Accessed: 27 March 2024). 
3. Early Alzheimer’s Disease: Developing Drugs for Treatment Guidance for Industry DRAFT GUIDANCE. (2018). Available at: https://www.fda.gov/media/110903/download.
4. (2012) Guideline on clinical investigation of medicinal products in the treatment of Parkinson’s disease. Available at: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-clinical-investigation-medicinal-products-treatment-parkinsons-disease_en.pdf-0 (Accessed: 28 March 2024.
5. (No date) Roadmap for treatments that make a difference in Parkinson’s disease: Available at: https://www.michaeljfox.org/sites/default/files/media/document/Roadmap for PD Treatments_August 2019_(DRAFT FOR PUBLIC COMMENT).pdf (Accessed: 27 March 2024).