Revolutionising how we test new treatments for Parkinson’s
Clinical trials are a vital part of research, but it’s a long process with many hurdles. Can new ways of working change how we carry out clinical trials for Parkinson’s and help us find better treatments, faster?
Current treatments for Parkinson’s work to manage symptoms of the condition, but we know they’re not good enough. And we still don’t have any treatments that can stop Parkinson’s from getting worse. Researchers across the globe are working on new ideas, leading us closer to finding a breakthrough treatment that can stop, slow or even reverse the progression of the condition.
What is a clinical trial?
Once research in the lab has identified a potential new treatment, an important next step is to trial it in people living with Parkinson’s. This is called a clinical trial. They help researchers understand the safety and effectiveness of a treatment, as well as look for any potential side effects.
Currently, there are 153 clinical trials taking place worldwide for Parkinson’s. Whilst this offers a lot of hope, setting up and running these trials quickly is a major challenge. However, reimagining this process is possible.
Traditional way of doing clinical trials
For a new treatment to be deemed safe and effective, a few different stages of clinical trials must take place: phase 1, phase 2 and phase 3. Research moves onto the next phase once results show that the drug has the desired effect and there are no severe side effects. Read our blog to learn what it’s like to take part in the drug trial.
For each drug, and at every phase, a clinical trial must be set up from scratch. This lengthy process involves:
- Securing funding so that there is enough money to run the trial.
- Developing all study documents, including the protocol which outlines every detail of how the trial will run.
- Ensuring that the treatment can be manufactured correctly and shipped and stored in a safe way to all study sites.
- Getting approval from regulators who check that the trial will be carried out in an ethical and responsible way.
- Setting up the study sites once approval has been granted to carry out the trial at each site, and training the staff at these sites to be able to carry out the trial safely.
- Recruiting people to take part in the study once it has opened.
Following these steps to the end of phase 3 means that it can take over a decade to understand whether a new treatment will work for people with Parkinson’s. And at the end, we only have an answer for the 1 treatment that has been through this process. If a treatment makes it through phase 3, it still then faces a lengthy process of approvals before it's rolled out and available to the public.
It took a long time to get to where we are, and that's because there is quite a lot involved in setting up a clinical trial.
Mairead Cullen, Trial Manager for a phase 3 trial of ambroxol, ASPro-PD
It’s like funding and building a brand new football stadium each time a football match is played. And then dismantling it once the game is over, ready to do the whole thing again the next time you want to play a match. This is a massive undertaking, and a hugely inefficient use of resources. Wouldn’t it be better if we didn’t have to rebuild the stadium each time?
A new way of doing things
Other medical conditions, including prostate cancer and multiple sclerosis, have adopted a different approach. They’re using a new format to run clinical trials, called a multi-arm, multi-stage (MAMS) trial. MAMS trials enable many promising treatments to be tested at the same time, speeding up research and finding new solutions to improve care.
Taking learnings from these success stories, it’s now time for Parkinson’s research to move towards these faster and more efficient clinical trials.
Trialing multiple treatments with the same infrastructure
The Edmond J Safra Accelerating Clinical Trials for Parkinson’s Disease study, called EJS ACT-PD, is adopting the MAMS format in a new trial which will speed-up the testing of treatments with the potential to stop or slow Parkinson’s. This project is funded by the Efficacy and Mechanism Evaluation (EME) Programme, an MRC and NIHR partnership, Cure Parkinson’s, The Michael J Fox Foundation, Parkinson’s UK, The John Black Charitable Foundation, The Gatsby Charitable Foundation and Van Andel Institute.
EJS ACT-PD will test multiple new treatments at the same time, in separate treatment groups, within one clinical trial. So using the same sites, recruiting from a central pool of interested participants, and using the same funding. This saves on the lengthy and costly process of setting up and testing treatments in separate trials. In other words, we only have to build the football stadium once.
Georgia, Research Project Manager for the EJS ACT-PD initiative shares what makes this clinical trial different.
“In EJS ACT-PD, we'll be able to test multiple treatments at the same time, against only 1 placebo group.
If a treatment doesn’t look promising, we can stop pursuing it and open a new treatment in its place, for as long as we have funding. We don’t need to shut down and start again. It’s a way of getting lots of answers at once, saving money, and more importantly, time.
A new Parkinson’s research registry
One of the main reasons for delays in clinical trials is slow participant recruitment. The faster a trial can attract the target number of people to take part, the faster a trial can come to a close and publish results. As many as 1 out of 2 clinical trials are delayed because they can’t find the right people to take part fast enough.
Currently, most clinical trials rely on people getting in touch if they are interested in taking part in a study. The new Join Parkinson's Research (JPR) online registry hopes to change this. The registry, called JPR@Research+Me, will enable people to register their interest in taking part in Parkinson’s studies. Researchers will then reach out directly to those who are suitable for their study. This will take the onus off individuals to get in touch, and get the right people signed up, faster.
Kate Hockey and her husband, Phil, who has Parkinson’s, have both worked closely with the team to design the registry. They shared:
“I’m delighted to be involved in the Join Parkinson’s Research project. The unique way in which it will match individuals with research projects represents a welcome change.
“The JPR@Research+Me portal will revolutionise the way in which people like me find out about research opportunities. I am excited by this development and look forward to using it in the near future.”
You can already join the registry as it continues to develop as an important new tool for research. To join the registry, visit the Join Parkinson’s Research website.
Testing treatments in a quicker, more effective way, and speeding up recruitment will get us closer to a major breakthrough in the search for better treatments for Parkinson’s.
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