One of the most frustrating aspects of the way we currently conduct clinical trials is the time it takes to run a study and the long delays between them. Multi-arm, multi-stage (or MAMS) clinical trials offer a potential solution to this cumbersome situation and it is Cure Parkinson’s hope that a MAMS clinical trials platform can be fully set up for Parkinson’s in the near future.
Recently, the UK Multiple Sclerosis Society provided an update on their large MAMS clinical trial programme for progressive Multiple Sclerosis. This new study platform, called ‘Octopus’, represents an important milestone for neurodegenerative research in the UK.
Cure Parkinson’s funded a process led by Dr Camille Carroll (Plymouth University) to better understand the practicalities and requirements of a MAMS platform for Parkinson’s.
Now, plans are well underway to conduct disease-modifying clinical trials for Parkinson’s following a UK-wide collaboration of Parkinson’s experts and stakeholders, alongside international input and oversight. It is a well-known fact that clinical trial testing takes many years to complete, often taking around 10-12 years to gather all the data needed from studies – this is especially challenging in Parkinson’s because the condition continues to progress over time. The current approach to testing a new treatment is to compare it with a placebo (an inactive dummy drug) over a long period of time, and only analyse the results of the study once all trial participants have finished being assessed. This system does not best-serve the Parkinson’s community nor the healthcare system, faced with the ever increasing cost burden of this progressive disease.
The EJS ACT-PD clinical trials platform is a MAMS process which will, it is hoped, transform the way clinical trials for Parkinson’s are conducted by allowing multiple drugs to be tested in parallel against one placebo group; moving immediately from phase 2 to phase 3 clinical trial testing following positive interim assessment, with new drugs continually being brought into this trial process each year. Rather than waiting until the end of the trial to find out whether a treatment works, the data will be assessed throughout the study by an independent monitoring group to identify any signs of efficacy, and end those treatments that are not working, replacing them with a new treatment to be tested.
The EJS-ACT-PD MAMS platform for Parkinson’s has been designed to be as wide-ranging as possible with numerous trial sites across the country and minimal inclusion/exclusion criteria – it is estimated that over 1,500 people with Parkinson’s will be recruited in the first phase of this study. We are optimistic that the EJS ACT-PD platform will begin in 2024 and are excited that it will enable more potentially disease-modifying drugs identified and prioritised through our iLCT programme to be tested for Parkinson’s each year!
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