The Cure Parkinson's Trust (CPT) has joined Parkinson's UK (lead funder) and others in a consortium project - the new “Critical Path for Parkinson’s (CPP) Consortium”. The consortium, involving industry regulators and other interested parties from academia to charities, is focused on data sharing and regulatory science relevant to Parkinson's (PD) across the globe.  It is interesting that in this consortium one of the objectives is to agree a common standard of data collection and CDISC is mentioned as the preferred format and a collaborator.  This is an area that is of particular interest to CPT as we wish the data from the trials that we support to be used in the best way possible for the advancement of the understanding of the condition and the improvement of clinical trial design, therefore the format of data collection is crucial. The first work plan for the consortium is described as:

“The primary objective of this international consortium is to collect, standardize, and aggregate clinical trial data in order to create a database that will enable robust description of the disease progression of PD in defined subsets of patients. This database will then be used to support the development of quantitative drug development platforms for PD, which will be put through a formal review process at the FDA and EMA for regulatory endorsement. This process is a key element that will facilitate the development and registration of future potential new medicines to treat PD. C-Path data management will  use PD specific CDISC clinical data standards, the format recommended by regulatory agencies." 

The consortium has access to data from several large PD studies and have committed to contribute it to the consortium for analysis.  It will be brought into a data set compliant with the CDISC format. We assume that future additions to this valuable database will ideally need to be in CDISC format - another reason for CPT to consider how best to ensure that its clinical trials align with streamlined regulatory review of new drugs.

Update November 2016:

Further evidence of the benefits of sharing data and CPT’s involvement in the CPP Initiative – 'The regulators issue letters of support for the use of imaging biomarker for dopamine uptake in clinical trials' - read the full article here.

Interestingly in the UK, NICE are also proposing positive support for the use of this imaging process in the revision of its current guidelines for PD – CPT have been involved in the consultation and have submitted comments in line with patients views.

CPP brings together pharmaceutical companies and academic partners working toward a common goal of establishing best practices and more efficient protocols for planning and designing clinical trials in early Parkinson’s. See the CPP webpage for more information.