The Importance of Results and Data

The Cure Parkinson's Trust (CPT) has long been aware of the challenge of ensuring that all research results are published, not just the exciting and positive ones. A recent article in 'Neurology Advisor Nov 2017' highlighted the on-going issues in the controversial area of publication of completed research studies and clinical trial results, albeit with a US bias. The problem is nevertheless a universal cause for concern.

Read the full article here: 'Publication Bias in Neurology Research: Why It Matters and Why It Needs to Change' - by Helen Fosam PhD. CPT is committed to continuing to tackle the problems outlined in this excellent article.

The availability of results and data can make an enormous contribution to better future experimental design and clinical trials.

In our current Terms and Conditions for grants, CPT insist on results being published, we are involved in the valuable initiative to collect and better utilise data (our partnership within the CPP Critical Path), we are addressing the issue of patient consent to help to make people with Parkinson's aware of how valuable their data can be and to ensure that they determine its use (see 'Rising to the Challenge...' article below) and we are directly addressing the vexed issue of publication bias by joining the AMRC collaboration to provide a new 'Open Access' platform that will enable publication of ALL study results and will ensure that the supporting data accompanying such publication is available for scrutiny by others. Please keep checking here for updates as we progress along this path.



Rising to the Challenges of Clinical Trial Improvement in Parkinson’s Disease

The drug development process is a long and arduous one, with many perceived and real barriers adding to its complexity. For researchers, lack of funding and support are cited as major barriers whereas for patients, the concern over side effects and perceived potential disruption of their ongoing medical management were the most influential determinants.

The Cure Parkinson's Trust believes many of these issues can be mitigated by involving the patient community in all areas of treatment discovery and development. 

We seek to develop and deliver stronger partnerships between the research and patient communities, and in so doing, expedite the search for better treatments and ultimately a cure.

Despite an urgent need for new medications, clinical trials in Parkinson’s have a relatively low rate of success. Although many reasons have been proposed for this, the opinions of patients and scientists, the two principal stakeholders, have not been widely canvassed.

The objective of this study by Parkinson's Movement (published in 2015) was to establish the main barriers to clinical trials success in Parkinson’s, as perceived by people with Parkinson’s and those engaged in conducting clinical trials in Parkinson’s.

Clinical trials are necessary to see how effective or safe certain treatments, interventions or diagnostic tests are in humans. They are also important in gaining information about a disease, how it manifests and the clinical course that it takes.
Drug development is not an expeditious process. For a new treatment to get from the idea stage to the pharmacy shelf it takes time, usually 10–15 years as the initial concept journeys through basic research, preclinical testing, clinical trials and finally regulatory approval.

This process is a costly one. A recent projection by the Tufts Center for the Study of Drug Development [2] puts the total cost for developing a drug at $2.9 billion. $1.4 billion of that amount going towards drug discovery and development costs with the remainder attributable to the loss of potential returns on investment and costs incurred following a drug’s approval.

Read the Full Research Article with citations - 'Rising to the Challenges of Clinical Trial Improvement in Parkinson’s Disease' - Authors: Mathur, Soania | DeWitte, Steve | Robledo, Israel | Isaacs, Tom| Stamford, Jon

The Clinical Trials Charter

The potential impact of the Clinical Trials Charter is currently being evaluated in PD-Stat, a UK based clinical trial testing simvastatin as a potentially disease modifying drug. This evaluation involving questionnaires and interviews, has revealed that to date, 163 feedback surveys have been received from the 223 posted to participants following their baseline clinic visits (i.e. 73% response rate).

Of the 91 (56%) participants who read the Charter, 92% of participants felt the Charter helped them to have a good understanding of what is involved in taking part in a clinical trial and 60% said that the Charter helped them make their decision about whether or not to take part in the trial:

• “We found everything useful and it was a very helpful guideline to the process involved”

• “I have a better understanding of how Clinical Trials work”