Strength in standardisation: developing CDISC standards for malaria

7 December 2015

WWARN and CDISC are working in partnership to develop the first malaria clinical data standard which will facilitate alignment of electronic acquisition, exchange, submission and archiving of clinical malaria data collection.

Data sharing has become an essential part of clinical research and is required by an increasing number of journals, funders and medicines regulatory agencies. A critical part of data sharing is the standardisation of clinical data. Although it can be a complicated process, standardisation improves clinical research through increased data quality, better data integration, and reusability; it can also facilitate the sharing of data.

The Clinical Data Interchange Standards Consortium (CDISC) has been addressing for the past 18 years the immense task of developing ‘a common language for clinical research’ by standardising the acquisition, exchange, submission and archiving of clinical data. CDISC data standards have now been developed for many disease areas including tuberculosis and hepatitis C.

Recently, 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 these CDISC standards. The Japanese Medicines Authority (PMDA) has also announced their plan to require CDISC standards. The European Medicine Authority (EMA) are also considering adopting certain of these global data standards.

For the past 6 years WWARN has been developing tools and platforms for standardising, curating, pooling and archiving data, and has encountered many of the difficulties associated with variable data and the lack of a standardised approach in the field. Building on this experience WWARN has partnered with CDISC to develop a single, freely available, global standard for clinical and safety data for malaria. This data standard will facilitate alignment and development of a new standard for the electronic acquisition, exchange, submission and archiving of clinical malaria data collection, analysis and reporting.

“We are now at the forefront of developing a data standard for the malaria research community. The aim of this initiative is to support the efficient, scientifically valid, generation and reporting of malaria clinical data, and to conform to regulatory requirements for registration of new antimalarial compounds,” says Lesley Workman, Coordinator of the WWARN Pharmacology Group who is leading on the CDISC project.

The initial proposal drafted by WWARN’s Pharmacology Module - led by Professor Karen Barnes from the University of Cape Town - was approved by CDISC in December 2014. Since then both WWARN and CDISC, in close collaboration with stakeholders, have been working on the development of concept maps to define the disease profiles for both Plasmodium falciparum and Plasmodium vivax malaria and to develop an annotated CRF (case record form) template which will guide the standards development process.

To ensure an open and consensus-based standards development process, CDISC project stakeholders from the malaria research community include pharmaceutical companies, academic researchers, and non-governmental organisations active in antimalarial drug development.

The standard will focus on the following areas specific to malaria: presenting symptoms, clinical and laboratory findings on presentation and during follow-up, medical history, drug administration, antimalarial drug concentrations and Adverse Events of Special Interest.

"The development of CDISC standards for malaria is something which will help simplify regulatory review for new anti-malarials.  Its particularly exciting to see South Africa taking a lead in this area," says Dr Tim Wells, Chief Scientific Officer for Medicines for Malaria Venture.

“The adoption of the CDISC standards has been steadily increasing as users, including regulators, continue to appreciate their value in streamlining data sharing and paving the way to new treatments for patients,” stated Dr Rebecca Kush, CDISC President and CEO. “We are thrilled to be collaborating directly with WWARN, who have an established track record for improving data quality and promoting standardisation within the malaria research community.”

A CDISC standard for malaria clinical data should be completed by August 2016. Keep watching the WWARN website for further updates on the project. For more information on the CDISC project, please contact Lesley Workman on pharmacology [at] wwarn [dot] org.