A future of better clinical trials
In recent years, a number of promising treatments for Parkinson’s have failed to show benefits in clinical trials. But is this because the treatments don’t work or is it due to the way the trials were designed?
What are clinical trials?
Clinical trials are used to prove the safety and effectiveness of new treatments and therapies by carefully testing them in people.
There are multiple phases of clinical trials that a treatments must pass through before it is made available to people. These phases individually take years and together can take decades. Clinical research is often the most expensive part of research into new treatments, and the vast majority of clinical trials are conducted by large pharmaceutical companies who can afford to invest in these studies.
Ultimately the aim of a clinical trial is to provide enough evidence that a treatment is safe and effective to get it officially approved. Regulatory organisations, such as the European Medicines Agency, will decide if there is sufficient evidence to approve the new treatment for use in people.
It there is insufficient evidence of the benefit of a new treatment then further clinical trials will be required, slowing down the delivery of treatments to the people who need them and possibly making them more expensive.
Investing in clinical trials
There are lots of potential treatments that could progress into clinical trials, but the large investment of time and money required to complete trials means that pharmaceutical companies only take forward the most promising research.
Not all clinical trials are successful and during difficult economic times, when money is tight, drug companies are even more selective about picking the best research to take forward.
Additionally, Parkinson’s research is seen as a difficult area. There is a very poor track record as a number of potential new treatments for Parkinson’s have failed at the final hurdle. This now deters investment into even very promising Parkinson’s research.
But we, and many others in the research community, believe the problem may not be that drugs don’t work but that there were problems with how the clinical trials are designed. If these problems can be overcome then there could be a higher chance that clinical trials will succeed, and that companies will be more willing to invest.
As Director of Research and Development at Parkinson’s UK, one of the questions I hear most often from our supporters is: ‘Why have there been no new treatments for Parkinson’s in the last several years?’ It’s a very good question and not one with a simple answer. But the most pressing reason is that the clinical trial process for Parkinson’s treatments simply isn’t up to scratch.”
— Dr Arthur Roach
How we’re improving clinical trials
The answers to better trials may already be out there. Lots of clinical trials and studies have generated a huge amount of valuable information and data about Parkinson’s. We believe this data could hold the key to designing better trials. But we are not making the most of it.
We’re partnering with the Critical Path Institute, @CPathInstitute, — an American non-profit organisation that specialises in developing tools to make clinical trials more efficient and effective. Together, we will bring all the key players together to share their data, expertise and ideas for making clinical trials for Parkinson’s better.
We’re working with researchers, drug companies and regulators to change clinical trials so they’re smarter, more likely to succeed and meet regulatory approvals.
— Dr Arthur Roach, Director of Research at Parkinson’s UK
If successful, the Critical Path for Parkinson’s will make clinical trials for Parkinson’s faster, cheaper and more likely to succeed. This should encourage more drug companies to invest in developing new treatments for Parkinson’s and ultimately help us achieve our mission to deliver new and better treatments in years, not decades.
Enjoyed this article? Read about our Virtual Biotech, a programme which is also aiming to speed up the delivery of new treatments: