New CDISC data standard aids development of therapies for Ebola virus

March 23, 2017, Infectious Diseases Data Observatory

The Clinical Data Interchange Standards Consortium (CDISC) and the Infectious Diseases Data Observatory (IDDO) announce the availability of a new standard to assist in the collection, aggregation and analysis of Ebola virus disease (EVD) research data. This standard is for use in EVD trials, leading to potential treatments and public health surveillance for this disease.

Ebola virus spreads through direct human-to-human contact and is often fatal, with a fatality rate that has ranged from 20% to 90% in past outbreaks. According to the WHO, the epidemic that began in 2014 in West Africa was "the largest and most complex Ebola outbreak since Ebola virus was first discovered in 1976." This singular outbreak resulted in over 11,000 fatalities, which is more than 7 times the fatalities of all previous outbreaks combined.

Version 1.0 of the CDISC Ebola Therapeutic Area User Guide (TAUG-Ebola) describes data concepts for use in Ebola clinical studies, so that investigators, data managers, statisticians, programmers and others that handle Ebola clinical trial data can understand the data and apply the standards appropriately. Having this data in CDISC standard format allows for more efficient aggregation and analysis of data collected from various studies across outbreak settings, thereby leading to an enhanced, automated process for developing evidence in evaluating Ebola treatments.

"There are many different actors involved in tracking, diagnosing, treating and containing an outbreak. Sharing information across these disciplines is critical to understand and respond to a disease , and is particularly important in the case of Ebola which has such devastating consequences." said Laura Merson, Associate Director of the Infectious Diseases Data Observatory (IDDO), and a clinical trial expert who coordinated the project on behalf of IDDO. "The CDISC Ebola data standard is a significant step forward that will enable a more rapid cross-disciplinary response which can reduce the impact of the next epidemic."

Laura Merson will be a keynote speaker at the upcoming 2017 CDISC Europe Interchange, to be held 24-28 April in London, England. During her presentation, she will share her experiences on the importance of sharing biomedical research data to change the paradigm of clinical research as it relates to outbreaks to enable rapid research response.

CDISC standards are required for submissions to the U.S. Food and Drug Administration (FDA) and Japan Pharmaceuticals and Medical Devices Agency (PMDA), are endorsed by the China CFDA, are requested for use by the European Innovative Medicines Initiative (IMI), and use of the Therapeutic Area User Guides is strongly recommended. CDISC highly encourages immediate use of the Ebola virus standard in clinical studies to ensure streamlined medical research practices, enhanced data sharing opportunities, and more rapid results for patients suffering from this disease.

This CDISC Therapeutic Area User Guide was developed through the Coalition for Accelerating Standards and Therapies (CFAST) initiative, a joint initiative of CDISC and the Critical Path Institute (C-Path), formed to accelerate clinical research and medical product development by creating and maintaining data standards, tools and methods for conducting research in therapeutic areas that are important to public health. Development of the TA standards includes invaluable support and advice from such organizations as the National Cancer Institute (NCI), Innovative Medicines Initiative (IMI), TransCelerate BioPharma, and regulatory agencies, including the U.S. Food and Drug Administration (FDA), the Japan Pharmaceutical and Medical Devices Agency (PMDA), and the European Medicines Agency (EMA).

Explore further: New database for sharing MS clinical trial data

Related Stories

New database for sharing MS clinical trial data

April 25, 2016
A new database containing nearly 2500 patient records from the placebo arms of nine multiple sclerosis (MS) clinical trials is now available for research by qualified investigators. This is just one of the tools generated ...

UN: Latest Ebola outbreak in Guinea is now over

June 1, 2016
The World Health Organization says the latest Ebola outbreak in Guinea has ended and the country is now entering a 90-day heightened surveillance period to monitor for any unexpected cases.

Blood test can predict life or death outcome for patients with Ebola virus disease

January 19, 2017
Scientists have identified a 'molecular barcode' in the blood of patients with Ebola virus disease that can predict whether they are likely to survive or die from the viral infection.

Societal challenges and new treatments for Ebola virus disease

July 6, 2015
Since Ebola was first described in 1976, there have been several outbreaks, but all have been self-limiting. In a new Journal of Internal Medicine review, Dr. Ali Mirazimi of the Karolinska Institutet considers why the latest ...

DR Congo declares itself Ebola-free

November 15, 2014
The Democratic Republic of Congo on Saturday declared itself Ebola-free, after a three-month outbreak of the killer disease claimed at least 49 lives.

Recommended for you

Malaria study reveals gene variants linked to risk of disease

April 25, 2018
Many people of African heritage are protected against malaria by inheriting a particular version of a gene, a large-scale study has shown.

Commonly prescribed heartburn drug linked to pneumonia in older adults

April 24, 2018
Researchers at the University of Exeter have found a statistical link between pneumonia in older people and a group of medicines commonly used to neutralise stomach acid in people with heartburn or stomach ulcers. Although ...

Kids with rare rapid-aging disease get hope from study drug

April 24, 2018
Children with a rare, incurable disease that causes rapid aging and early death may live longer if treated with an experimental drug first developed for cancer patients, a study suggests.

Early treatment for leg ulcers gets patients back on their feet

April 24, 2018
Treating leg ulcers within two weeks by closing faulty veins improves healing by 12 per cent compared to standard treatment, according to new findings.

Research finds new mechanism that can cause the spread of deadly infection

April 20, 2018
Scientists at the University of Birmingham have discovered a unique mechanism that drives the spread of a deadly infection.

Selection of a pyrethroid metabolic enzyme CYP9K1 by malaria control activities

April 20, 2018
Researchers from LSTM, with partners from a number of international institutions, have shown the rapid selection of a novel P450 enzyme leading to insecticide resistance in a major malaria vector.

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.