By Nicole Harmon, Chief of Staff at CDISC

Published: 7 September 2017

The UK medical research sector is not alone in its search for ways to streamline clinical research and enable connections, this is a challenge faced by research communities across the US and the globe. CDISC, a global, non-profit charitable organisation based in Texas, is on a mission to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare. In this blog Nicole Harmon, PhD, Chief of Staff at CDISC tell us about their Therapeutic Area User Guides and how they can help your studies ‘speak the same language’.

I think we can all agree patient data is a valuable resource. Just as medical professionals devote themselves to improving health, the care and proper attention to using patient data should be of utmost priority to patient foundations funding research. Each time your organization funds or advocates for a research study, have you thought about how the study data are organised from collection to analysis and whether it can be shared and understood by other researchers?

Speaking the same language across studies

Putting data into a standardised format, provides researchers with common, familiar formats to collect, tabulate, and analyse data throughout a study’s lifecycle. Standardising data also allows it to speak the same language across studies, which facilitates sharing and comparing of data from different studies making it possible for research teams to learn what’s working and what’s not. CDISC’s standards can organise research data into a common format that can be used in helping to create a disease registry database, for example. Our Therapeutic Area User Guides go further, showing you how to apply CDISC standards to specific diseases and treatments. These User Guides provide the terminology and structure you need to ensure that your studies speak the same language. They also act as a multiplier for every pound you invest in supporting clinical and translational research, because standardised data makes it possible for you to look across studies to see trends impossible to see from a single study.

Light bulb moment

Prior to joining CDISC, I was the Research Director for a Brain Injury Rehabilitation hospital where I led the development of a protocol and case report form for our neuroimaging study, evaluating patients, before and after, participating in our cognitive rehabilitation program. I rarely thought about how I was formatting the data and how organising it in a standard format would allow me to more efficiently share and compare this important information for reuse. That was, until I joined CDISC. Then a light bulb came on about how my research investment could be multiplied, if only the data were in a standard format to improve its quality and traceability so that it could be shared more efficiently and effectively.  

CDISC standards

CDISC is a global, non-profit organization that develops data standards to enhance the quality, efficiency and cost effectiveness of clinical research processes from beginning to end to foster smarter research. CDISC standards are consensus-based, vendor-neutral, and freely available via the CDISC website. CDISC began as a grass roots initiative in 1997 in response to the need to better structure and improve the quality and consistency of data in clinical research. Volunteers came together to create workgroups and share the idea of CDISC, building awareness and generating support. Today, through the hard work and collaborative efforts of a variety of stakeholders, CDISC Standards are required for regulatory submissions to the U.S. FDA and Japan PMDA, endorsed by the China CFDA, and requested for use by the European Innovative Medicines Initiative (IMI).

The value of using standards goes beyond complying with regulators

We have partnered with patient foundations such as Bill and Melinda Gates Foundation, One Mind for Research, Cohen Veteran’s Bioscience, Critical Path Institute, World Wide Anti-Malarial Network, Parent Project Muscular Dystrophy, CHDI, and many more to develop Therapeutic Area standards, which extend our Foundational Standards to represent data that pertain to specific disease areas. In five years, we have developed Therapeutic Area standards for over 30 disease areas.

Application of CDISC standards has led to changes on how low weight children suffering from Malaria in sub-Saharan Africa are treated, causing reduction of mortality in these vulnerable patients. It has also supported discovery of clinical research biomarkers for Polycystic Kidney Disease and Parkinson’s Disease. The evidence had been hidden for years prior to standardisation, aggregation and analysis. These biomarkers now enable researchers to identify diseases early, when intervention may be possible.

You can learn more about our work in specific disease areas and our partnerships with various European initiatives by visiting our website.

Supporting WHO’s initiative

In May, the World Health Organization (WHO) published a joint statement on public disclosure of results from clinical trials, with 12 funding organizations signing to affirm that they support prospective registration and timely public disclosure of results from all clinical trials as critical scientific and ethical importance. CDISC supports this initiative and will proactively be a voice for how data standards can support WHO’s efforts to improve research through data integrity. We invite you to visit our website to learn more about what CDISC standards are available in your research area, reach out to us to learn how to train your team to make the most from the standards and partner with us to develop new Therapeutic Area Standards for the disease area most important to you and your constituents. We look forward to working with you to multiply your research funding and unlock the breakthroughs and treatments that are waiting to be discovered in your research data.