At present, most clinical trials for Parkinson’s involve a single therapy, being tested against a ‘placebo’ or control treatment for a fixed period of time.
At the end of the study, the results are compiled and analysed, allowing for conclusions to be made. The whole process takes a considerable time especially when clinically testing each new therapy one at a time.
Recently, Dr Camille Carroll – consultant neurologist at Plymouth University and member of the International Linked Clinical Trials committee – led a group of researchers in a review of a new type of clinical trial – termed a ‘multi-arm, multi-stage’ study or MAMS study. The design of a MAMS study would involve investigating different therapies across multiple arms all at the same time. This would allow for several therapies to be compared to one placebo, rather than testing each of them individually in a study.
In addition, the data from each arm of the study would be analysed on an ongoing basis as the trial is conducted, which would allow for ineffective treatment arms to be dropped then replaced with new treatment arms. The MAMS study method would lead to a more dynamic and adaptive form of testing for new potential therapies. Dr Carroll and colleagues have published their review in the Journal of Parkinson’s Disease. In their report, they consider the pros and cons of this MAMS style of trial, review examples of its use in other medical conditions, and discuss potential MAMS use in the context of Parkinson’s.
Helen Matthews, Deputy CEO, Cure Parkinson’s said:
We need to explore all new thinking about clinical trial design, as this will enable us to learn more rapidly whether a treatment has the potential to change the progression of Parkinson’s. We also need research programmes to be more of a continuum to reduce the ‘stop…start’ nature of clinical research. This paper is an important step as is the Australian Parkinson’s Mission’s approach to run multi-arm trials testing three or four compounds against a single placebo group.
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