Three entities — the Clinical Data Interchange Standards Consortium (CDISC), the Critical Path Institute (C-Path) and the CHDI Foundation (CHDI) — have announced that the Huntington’s disease (HD) Therapeutic Area User Guide (TAUG-HD v1.0) is up for public review through Nov. 10.
TAUG-HD v1.0 was developed through the Coalition for Accelerating Standards and Therapies (CFAST) consortium, a joint initiative of CDISC and C-Path. The consortium was formed to accelerate research and medical product development by creating and maintaining data standards, tools and methods for conducting research.
The consortium received support and guidance from the most relevant regulatory agencies worldwide, including the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) and Japan’s Pharmaceutical and Medical Devices Agency, among others.
TAUG-HD v1.0 describes how HD clinical data should be recorded in a standardized database to guarantee a set of common best practices across the industry, as well as to establish standard practices in the recording, reporting and sharing of clinically relevant research and metadata and patient information. Such information would include family history, genetics and biomarkers to assess disease onset and progression.
Specific biomarkers used in the guide include magnetic resonance imaging (MRI) and positron emission tomography (PET) scans, as well as cerebrospinal fluid analyses.
Standardizing practices will allow the HD research community to compare and contrast data across studies more easily and with more scientific accuracy. It also is anticipated to facilitate regulatory submissions for novel therapeutics.
Today, CDISC standards have been adopted and used by more than 90 countries and are required by authorities in the U.S. and Japan. Use of CDISC standards has proven capable of saving time and resources. HD researchers are encouraged to implement these standards, which is why they would benefit from using this time to review the document and give some feedback.
The public review period began Sept. and will run through Nov. 10.
“As we move forward with the aggregation of clinical data sets, it is our hope to create tools that will inform innovative clinical trial designs, which can help expedite development programs. It is an ideal moment for the development of a CDISC TAUG that will standardize nomenclature, formats, collection, and reporting of these new forms of data. C-Path’s collaboration with CHDI and CDISC on this user guide is both valuable and timely,” Martha Brumfield, PhD, C-Path president and CEO, said in a press release.
“The HD research field is now at the threshold of important clinical developments that will help us move some of the promising therapeutic candidates in the pipeline to clinical trial,” added Cristina Sampaio, MD, PhD, chief clinical officer at CHDI Management. “This collaboration to develop universal data standards is another example of how the highly collaborative nature of the HD research community can accelerate therapeutic development for the benefit of patients and their families.”