INVESTOR NEWSLETTER ISSUE N°3


2020 challenge by being “an agile, knowledge-directed industry.”


“Information about patients and the medicines they need will become as important as the medicines they need. [The Pharma industry must prepare] by being an agile, knowledge-directed industry.”


 - Dr. Dipak Kalra, CDISC Board of Directors


Dr. Kalra also spoke, when requested, of the recent EHR4CR meetings at IMI in Brussels, which was attended by nearly 200 people from hospitals interested in how their data could be used to support clinical research feasibility. Dr. Fitzmartin stated that 45CFR170 regulates EHRs (not 21CFR11) and that last fall FDA issued the FDA eSource Guidance, encouraging the use of eSource, including EHRs for research. Ms. Slack added that they have just created a Health IT Board at FDA, mentioning that they are anxious and interested in data from EHRs supporting Clinical Research. The remit of the Health IT Board is to identify projects in this space. Dr. Sweeney stated that they have not yet used the tools of EHR4CR, but that they could see those tools becoming very useful in the near future.


CDISC, the World-Wide Antimalarial Resistance Network & the Global Health


Network Lesley Workman, WWARN Pharmacology Scientific Coordinator I greatly appreciate the sponsored opportunity to attend 3 full days of CDISC training and the CDISC Interchange in Paris this month. The knowledge and skills that I have learnt will be of huge benefit to both the World-Wide Antimalarial Resistance Network (WWARN) and The Global Heath Network which I represented.


WWARN was established 5 years ago to ensure all malaria patients receive safe and effective treatment by providing the comprehensive, timely, quality-assured intelligence needed to track the emergence and spread of malaria drug resistance. WWARN invites all malaria researchers to contribute data to pooled analyses, and includes pharmacology, molecular, in-vitro, drug quality and clinical efficacy data across location and time. The data contributed by research groups were in many different formats, with varied study methods, many variable names for similar clinical terms and a range of units used, creating challenges for pooling these data. Most researchers were keen to be


CDISC WEBSITE LINK


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APRIL 2014


involved and realized the importance of harmonizing methods and sharing data to answer global public health questions not achievable with individual studies. WWARN also provides a secure data repository, addressing the most common reason for not contributing data – namely that the primary data from their previously published studies had been “lost.” The incentives to retain these source data after publication were weak, especially for studies completed before about 2005. The WWARN experiences have highlighted the urgent need for international data standards for malaria, as well as a recognized data archive standard such as that promoted by CDISC.


The Global Health Network has become known as a trusted source of information and tools for streamlining and supporting clinical research, especially from resource-limited academic institutions. The Network has highlighted the need to share clinical research data globally, and is implementing Databox, which will provide a comprehensive set of resources and tools for good data management as well as access to recommended data management selected via a critical analysis of data management systems. These initiatives will guide institutions in selecting appropriate tools for adoption, and keep them informed of emerging technologies for data management in clinical research. In addition, by the provision of access to standardized data collection instruments and support for standardized data documentation, Databox will assist researchers and data management staff to adopt best practices to produce datasets that can be shared and are optimized for pooled analysis.


Both WWARN and The Global Health Network work closely together and are keen to promote the use of the international data standards to ensure data integrity, validity and that the data collected are suitable for sharing, especially in low-resource settings. The CDISC training has equipped me with the skills needed to implement the first steps for both groups to align with CDISC standards. The CDISC conference also allowed me the opportunity to meet and discuss the way forward with others involved in developing new data standards for malaria. We then hope it will be


“The CDISC training has equipped me with the skills needed to implement the first steps for both groups to align with CDISC standards. The CDISC conference also allowed me the opportunity to meet and discuss the way forward with others involved in developing new data standards for malaria.”


-Lesley Workman, WWARN lin


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