Goverment is in the way !!

National Parkinson's Organizations Weigh in on FDA Clinical Trial Regulations

Clinical trials are a required step in the Food and Drug Administration’s (FDA) therapy approval process.  Central nervous system drugs – including those for Parkinson’s – are the slowest to develop and spend the longest amount of time in the development pipeline, taking an average of 15-20 years to get to market.  The FDA’s regulatory framework around clinical trials has a direct bearing on this long time-to-market.  Because science can oftentimes move more quickly than the federal government, the Parkinson’s community is pushing for a more efficient, effective clinical trials process to get new drugs and devices to market more quickly.

Earlier this year, the FDA issued a notice seeking input on how to modernize regulation of clinical trials.  In conjunction with the national Parkinson’s organizations, PAN led the effort to provide the Parkinson’s community’s recommendations to the FDA.  The resulting letter was submitted to the FDA on May 31 and was signed by PAN, American Parkinson Disease Association, The Michael J. Fox Foundation for Parkinson’s Research, National Parkinson Foundation, The Parkinson Alliance, and Parkinson’s Disease Foundation.

The organizations’ recommendations focus on three overarching topics:

Recognizing clinical trial participants’ rights and access to information;

Inclusion of the patient and community voice in consideration of the impact and burden of Parkinson’s (and other diseases) in trial design and implementation; and

Enhancing clinical trial efficiency, with respect to both trial duration and cost.

Within these three overarching topic areas, the Parkinson’s organizations made specific suggestions ranging from increased patient input and engagement on clinical trial design and greater transparency throughout the process, to better evaluation of risk-tolerance issues and use of alternative outcome measures since there is no Parkinson’s biomarker to be used for measurement.

To read the letter, click here.

If you have questions about this topic, please don’t hesitate to contact Becca O’Connor, Director of Government Relations at [e-mail].

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