One of the most frustrating aspects of clinical trials is the long delays between studies. Recently, Dr Camille Carroll of Plymouth University, who also sits on the International Linked Clinical Trials (iLCT) committee, has led a group of researchers in exploring the possibility of building a platform for conducting multi-arm multi-stage clinical trials for Parkinson’s.
During the trials process, study results are assessed and published; and if interesting, the investigators will seek funding for another study to further explore the treatment being tested. Then ethical and regulatory approval for the new study is sought… whilst some 2 to 3 years have passed before a follow up study can begin.
Now, Dr Camille Carroll of Plymouth University is exploring the possibility of building a platform for conducting multi-arm multi-stage clinical trials for Parkinson’s.
Multi-arm multi-stage (or MAMS) clinical trials involve the assessment of several treatments being assessed at the same time. This process is similar to the Australian Parkinson’s Mission trials that Cure Parkinson’s is supporting. The platform that Dr Carroll is proposing has some important differences:
1. Rather than waiting until the end of the trial to determine the outcome, in a MAMS study the data will be continually analysed as the study progresses. This continuous assessment will allow the investigators to be adaptive and periodically change the study if necessary – for example, removing therapies that are not working.
2. In addition to being adaptive, the MAMS platform would also allow for seamless transitions between phases of the clinical trials – shifting from Phase 2 to Phase 3 without a long delay.
MAMS trials have already been conducted with great success in the field of cancer research (for example the STAMPEDE study for Prostate cancer), and researchers are now exploring the use of MAMS studies for other neurodegenerative conditions like Alzheimer’s and multiple sclerosis.
Cure Parkinson’s is keen to remain well-informed and supportive of novel clinical trial design and efficient platform based testing, for future iLCT clinical trials of potentially disease modifying therapies. Dr Simon Stott, Deputy Director, Cure Parkinson’s, said:
As we move forward with more clinical trials in our International Linked Clinical Trials programme, we must address the clinical trial delay periods which slow down the entire process. A multi-arm multi-stage clinical trial platform would certainly help to address this problem, and Cure Parkinson’s is proud to be supporting Dr Carroll and her collaborators as they explore what is required.
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