The Clinical Data Interchange Standards Consortium (CDISC) and the WorldWide Antimalarial Resistance Network (WWARN) announced the availability of CDISC Malaria Therapeutic Area (TA) User Guide v1.0, the very first global malaria data standard that enables data capture and assessment for antimalarial drug efficacy, with the potential to speed the delivery of new and better therapies to patients afflicted with malaria.

While huge gains have been made against malaria over the past two decades, there were still 212 million cases of malaria infections in 2015 and 429,000 deaths, primarily children under the age of five in sub-Saharan Africa. Drug resistance to the available frontline treatments, artemisinin combination therapies (ACTs), is now firmly established in many parts of Southeast Asia and is threatening the recent gains made in the region in the move toward malaria elimination. Although there are many new treatments against malaria in the drug development pipeline, it will still be a number of years before these are available on the market. The use of CDISC standards for malaria will facilitate the review of new treatments by regulatory authorities and help maintain the efficacy of ACTs for as long as possible. A key step to achieving this is the sharing of information in a standardized format from across studies and geographical areas.

"The new malaria standard is a huge leap forward in the quest to improve the efficacy of existing antimalarial drug regimens and create new and better therapies for malaria patients around the world. It will save time and streamline the often complex process of collecting, submitting and sharing data on antimalarial resistance," said Prof. Karen Barnes, from the University of Cape Town, who leads the WWARN Pharmacology Group that initiated the CDISC malaria project.

Version 1.0 of the CDISC malaria standard describes the necessary metadata to represent malaria data consistently with CDISC standards. The associated malaria Case Record Form (CRF) has also been developed to help investigators implement this standard. CDISC standards are required for submissions to the US Food and Drug Administration (FDA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA). The FDA has recently published an update to its Study Data Technical Conformance Guide, which includes information on FDA-supported CDISC TA standards, including malaria. CDISC and WWARN highly encourage the immediate use of the malaria standard in clinical studies to deliver more streamlined medical research practices, enhanced data sharing opportunities, and more rapid results for patients suffering from this disease.

This CDISC Therapeutic Area standard was developed with assistance from the Critical Path Institute (C-Path) through the Coalition for Accelerating Standards and Therapies (CFAST) initiative, a joint initiative of CDISC and 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. Additional  assistance was provided by product development partnerships (notably the Medicines for Malaria Venture), pharmaceutical companies (including GlaxoSmithKline, Novartis, Sanofi, Takeda, Shin Poong, Sigma-Tau, Merck), the World Health Organization (Global Malaria Programme and Special Programme for Research & Training in Tropical Diseases, TDR), and academic researchers (from University of Cape Town, Oxford University, Menzies School of Health Research and Liverpool School of Tropical Medicine) active in antimalarial drug development.

Discussions on the CDISC Therapeutic Area standards will be highlighted at the upcoming 2017 CDISC Europe Interchange, to be held 24-28 April in London, England. More information about this event can be found on the CDISC website.

CDISC is a 501(c)(3) global, non-profit organization that develops data standards to foster smarter research and enable connections to healthcare. CDISC standards allow data to speak the same language, by providing common formats for data collection, data sharing and data analyses to make the most of the valuable information offered by patients participating in research studies around the globe, enabling researchers to discover new treatments, find breakthroughs, and unlock cures.

The WorldWide Antimalarial Resistance Network is a research partnership that provides comprehensive, timely, quality-assured evidence to help track the emergence and spread of malaria drug resistance, and improve the efficacy of existing antimalarial medicines and new drugs in development.

Critical Path Institute (C-Path), founded in 2005 in Tucson, Arizona, is an independent, nonprofit organization established with public and private philanthropic support from the Arizona community, Science Foundation Arizona, and the US Food and Drug Administration (FDA). C-Path’s mission is to catalyze the development of new approaches that advance medical innovation and regulatory science, accelerating the path to a healthier world.