Research Unites People Living with Parkinson’s

Research Unites People Living with Parkinson’s

06.05.14 | By Diane Stephenson, Ph.D.

Parkinson’s disease (PD) affects up to 1.5 million Americans and without any change, that number is expected to more than double by 2040. PhRMA’s 2014 Medicines in Development for Parkinson’s Disease report showed nearly 40 medicines are in the pipeline to help ease the tremendous burden of Parkinson’s on patients and their families.  More collaboration throughout the biomedical ecosystem will help better meet the needs of people living with Parkinson's, and allow us to continue to make strides against this global public health challenge. More in our guest post from Diane Stephenson, the Executive Director of the Coalition Against Major Diseases (CAMD). CAMD at Critical Path Institute (C-Path) is a unique public-private partnership of pharmaceutical companies, academia, patient advocacy/voluntary health associations, and government research and regulatory agencies formed to accelerate treatments for two of today's most devastating illnesses - Alzheimer's and Parkinson's diseases.

CAMD is one of seven precompetitive consortia of the Critical Path Institute, a nonprofit organization formed to deliver on the vision of US FDA’s Critical Path Initiative. CAMD focuses on accelerating therapies for Parkinson’s disease and Alzheimer’s disease by serving as a neutral third party enabling precompetitive data sharing and development of consensus data standards.

The Coalition for Accelerating Standards and Therapies (CFAST), a joint effort between the Clinical Data Interchange Standards Consortium (CDISC) and CAMD, was launched to accelerate clinical research and medical product development by facilitating the creation and maintenance of data standards, tools, and methods for conducting research in therapeutic areas important to public health. CFAST, in collaboration with the National Institute for Nervous Disorder and Stroke (NINDS), recently announced the availability of an important resource in the fight against Parkinson’s disease (PD).  This resource, called the Parkinson’s disease CDISC Therapeutic Area Data Standard, provides a defined and consistent way to collect, store, and submit clinical trial data for PD.

The U.S. Food and Drug Administration (FDA) has identified Parkinson’s Disease as one of several disease areas having a critical need for data standards, and will require the use of clinical data standards by 2017. The PD CDISC standards will facilitate regulatory review and enable greater sharing, pooling and ultimately increased understanding of data for multiple studies and therapies. This will eventually enable researchers to deliver new and improved therapies to patients.  From the patient’s perspective, “Research is the one thing that unites people living with Parkinson’s.”

The ability to compare trial results across studies is extremely challenging and without clear standards, it’s nearly impossible to learn from the past failed trials beyond looking at one study at a time. The PD CDISC standards promises to contribute to alignment and consensus across the industry, and the inclusion of biomarkers and clinical scales in the PD standard will assist with much-needed standardization in future clinical studies.

The release of PD v1.0 is the culmination of work by a dedicated team of Parkinson’s disease experts and reflects the high level of collaboration between CAMD, NINDS and CFAST. We are excited that the development of these standards, as they will significantly contribute to advancing PD drug development.

Scientists and researchers can access the standard on the CDISC site:


Hide Comments

More On PhRMA — powered by PhRMApedia


Cost in Context