Sharing data during an epidemic is extremely important for researchers to develop the necessary diagnostics, therapeutics, and vaccines to save lives. This also includes supporting the generation of evidence needed to strengthen essential public health guidance and actions to prevent and limit the impact of Zika virus and its complications. Within the three EU funded Zika research consortia, we are therefore working towards enhancing our clinical cohort studies through close collaboration, harmonization of protocols and data sharing plans. Initial protocols developed by the Microcephaly Epidemic Research Group (MERG) were shared with the other consortia, and also with the NIH funded ZIP study. The objectives of these studies are to investigate the relationship between ZIKV infection during pregnancy and adverse fetal/neonatal outcomes, identify risk factors, and describe the full spectrum of clinical manifestations of congenital Zika syndrome.
Furthermore, under the guidance and coordination of the World Health Organization (WHO), not only are the three EU funded Zika clinical cohort studies and the NIH funded ZIP researchers working together, but many other smaller projects are now joining to set up a larger consortium named the “ZIKV IPD Consortium”. WHO convened a meeting in Geneva from February14 – 15, 2017. Several representatives from the three EU-funded Zika consortia participated; ZikaPLAN participants included Prof. Ricardo Ximenes who leads the University of Pernambuco team and all the clinical cohort studies in Brazil, and Prof. Annelies Wilder-Smith (ZikaPLAN Scientific Coordinator).
The overall aim of the ZIKV IPD Consortium is to collaborate in order to achieve something that is bigger than individual projects. All participants agreed that such a consortium not only allows for more transparency in clinical research, but also enables research questions that cannot be addressed by individual projects to be tackled, in order to reduce duplication and optimize study design. This in turn increases the efficiency of the research process by linking data from multiple cohorts. Combined cohort studies result in a far larger sample size, better geographic representation, can address rare events and strengthen the epidemiological associations. In particular, they allow identification of co-factors or effect-modifiers that may be missed in individual projects. However, there are still many barriers that impede data sharing. During the meeting, concerns and potential solutions to incentivize or de-risk data sharing were discussed, as well as authorship issues. The outcome of the meeting was to develop an IPD-MA protocol and a data analysis plan with clear timelines. Further meetings are planned.