New IDDO perspective paper highlights challenges of sharing historical clinical trial data
In a new paper, researchers from the Infectious Diseases Data Observatory (IDDO) outline the challenges and lessons learned from conducting individual participant data meta-analyses (IPD-MA) in neglected tropical diseases.
The paper, Data retrieval and harmonisation for individual participant data meta-analysis in the context of a neglected tropical disease: Challenges and lessons from the Infectious Diseases Data Observatory visceral leishmaniasis data platform, also highlights the significant loss of historical clinical trial data and the long-term impact this loss has on the research community.
Unlike aggregate data meta-analyses, IPD meta-analyses analyse participant-level data from multiple studies, resulting in greater statistical power, and enabling sub-group analyses. They are therefore the gold standard approach for evidence synthesis.
IPD meta-analyses are particularly valuable for poverty-related infectious diseases, since clinical trial data are often scarce and studies are small, making it more difficult to identify drivers of treatment failures and generate robust evidence from a standalone study itself.
IDDO’s Dr Sauman Singh-Phulgenda, who led the development of the data platform said: “The IDDO platform, which was established on the principles of purpose-driven data sharing, equitable partnership, and responsible open access, now holds a critical mass of data from visceral leishmaniasis clinical trials. It is the result of the collective efforts of researchers, institutions, and scientists united by a shared common vision to advancing research and improving the outcomes for the patients affected by the disease. This is a neutral scientific platform for undertaking collaborative research.
“We hope that our experience of developing an international data-sharing collaboration, including the challenges we faced, and assessing the extent of historical data loss, and the benefits that data sharing can bring to research – will provide valuable insights and benefit colleagues planning some similar initiatives in other disciplines.”
Developing a visceral leishmaniasis (VL) data platform
In collaboration with the global research community, IDDO developed a data platform for visceral leishmaniasis (VL), a neglected tropical disease, to support IPD meta-analyses that addressed key public health questions.
The IDDO team first completed a systematic review to identify relevant VL clinical trials published since 1980. They then invited the researchers who led these studies to make their data available for reuse, and collaborate to develop the VL platform and associated IPD meta-analyses.
The systematic review found 147 VL clinical trials published between 1983 and 2019, but, only 31 studies - around one fifth - made their data available for reuse via the IDDO platform.
Reasons for non-sharing included:
- Historical data being lost
- Study leads retiring or becoming uncontactable
- Lack of response from study investigators
- Uncertainty around data ownership, despite willingness to share
IDDO researchers were unable to retrieve participant-level data from any trial published before 2000. They also found that, on average, it took 633 days from making the initial data sharing request to completing data curation and harmonisation, with the data fully available for reuse.
IDDO Head of Statistics and the study lead Dr Prabin Dahal said “This study adds to the growing body of literature recognising the challenges associated with data retrieval and harmonisation steps when undertaking individual participant data meta-analysis. The lengthy curation process reflects not just the time and effort it takes to harmonise and curate heterogenous data, but also the collaborative efforts required to custom develop standards tailored to the disease-specific context. Through the collective efforts of the scientific community, we have been able to overcome these challenges to realise a shared data platform that remains a value scientific resource.”
The findings underline both the importance of preserving clinical trial data and the need for sustainable, collaborative data-sharing platforms to support research on neglected tropical diseases.