Information from clinical trials is not easily available to most researchers, especially if the trials are sponsored by industry. Making information from clinical trials more widely available may help with the design and conduct of future trials. Researchers may also want to explore new ideas using information from completed trials.
The Parkinson Study Group (PSG) has completed several industry sponsored clinical trials. The information from these PSG trials is not widely available to researchers. We plan to first check with the sponsors of these trials to get their agreement, and then to make the information available to researchers. To do this we will develop methods to let researchers view and analyze the data, but not keep them. We will also develop a review process to be sure the researchers have a clear and practical use for the Information, and will share the results.
Relevance to Diagnosis/Treatment of Parkinson’s Disease:
Researchers may be able to design better clinical trials by review older studies. They may also be able to ask questions about things that influence the progression or features of PD. The answers to those questions may help guide future clinical trials.
We expect to have at least 3 databases that previously had restricted access available to researchers within one year. We will have a review process that does not impede researchers from obtaining data in a timely fashion, but does help to maintain the proper use of the information.
Over the past year, the Clinical Trial Coordination Center has requested permission from multiple pharmaceutical sponsors to post seven completed Parkinson Disease Clinical Trials conducted through the Parkinson’s Study Group. Permission has been granted to post to a secure server all data from six of the requested trials. Permission is still pending for one study.
The CALM-PD trial data has been de-identified, anonymized and documented for posting. The transformation of a second database is underway. Analysis of the CALM-PD trial is expected to begin in November 2010.