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Progress towards developing CDISC standards for malaria

27 June 2016

Draft standards are expected to be ready for release for public review by August 2016. 

To respond to the urgent need for novel drugs to address the scourge of drug resistance that is threatening highly effective antimalarials, WWARN has partnered with the Clinical Data Interchange Standards Consortium (CDISC) and the Critical Path Institute (C-Path) to develop a single, freely available, global standard for malaria clinical trial data and metadata. This standard will facilitate the electronic acquisition, exchange, submission and archiving, transforming malaria clinical trial data into useful information with the potential to speed the delivery of new and better therapies to patients.

These efforts are timely as the US Food and Drug Administration (FDA) mandated that data from clinical trials submitted for registration purposes, starting after mid-December 2016, will need to conform to CDISC standards. The Japanese Medicines Authority (PMDA) has also announced their plans to require CDISC standards and the European Medicines Agency (EMA) are considering adopting certain aspects.

To ensure an open and consensus-based standards development process, CDISC project stakeholders from across the malaria research community have worked together, including pharmaceutical companies (including Glaxo SmithKline, Novartis, Sanofi, Tadeko, Shin Poong, Sigma-Tau, Merck), the World Health Organization (Global Malaria Programme and Special Programme for Research & Training in Tropical Diseases, TDR), academic researchers (from University of Cape Town, University of Oxford, Menzies School of Health Research and Liverpool School of Tropical Medicine), and product development partnerships (notably the Medicines for Malaria Venture) active in antimalarial drug development.

A number of these partners will join WWARN’s Director Philippe Guérin at an FDA public workshop scheduled to explore clinical trial design considerations for malaria drug development. You can register to join the workshop by online webcast taking place on 30th June 2016 in Silver Spring Maryland, USA.

The initial focus of the development of CDISC standards for malaria is on uncomplicated malaria. Key areas include malaria microscopy and molecular methods data, adverse events of special interest and analysis considerations. We plan to share an annotated Case Record Form and a Therapeutic Area User Guide for public review by August 2016.

Please email pharmacology [at] wwarn [dot] org to request an alert when these drafts are open for public comment. We urge you to support us by reviewing these draft standards and sharing your suggestions.

Share your views and watch out for the CDISC malaria standards draft release on Twitter and Facebook @WWARN. Discover more about the CDISC’s mission and principals and C-Path’s support for global health efficiency and collaboration. 

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