Data need to be brought together to benefit clinical trials, researchers warn
Clinical trials are essential for finding out whether new treatments work. Increasing use of NHS data will make trials more efficient. Secure data environments play an important role in protecting privacy of sensitive health data and maintaining public trust.
A new study published in the International Journal of Population Data Science (IJPDS) examined what could happen if information about clinical trial participants is held across separate secure data environments in such a way that it cannot be analysed together.
A research group, led from UCL (Innovative Clinical Trials Unit and the MRC Centre of Research Excellence in Clinical Trial Innovation), funded by HDRUK and in collaboration with NHS England, compared two approaches. In a one-stage analysis, all relevant data can be analysed together within a single secure environment. However, if data must be analysed separately within each environment, then a two-stage approach is required, combining the separate results using a meta-analytic approach.
The study found that the two-stage approach can have important limitations, particularly for analyses that examine how long it takes for participants to experience a specific outcome, such as recovery, disease progression, or survival. It can also make it more difficult to investigate whether treatments work differently for particular groups of patients.
The authors argue that enabling trial data to be effectively brought together, in a secure location, for analysis would help preserve the efficiency and scientific value of clinical trials while maintaining high standards of data protection. As increasing amounts of health data become available through separate secure data environments, the findings highlight the importance of developing the technical and governance arrangements needed to enable secure analysis as if in one location.
By ensuring researchers can analyse data as though it were held in a single location, health systems may be able to support faster and more effective clinical trials, helping new treatments reach patients sooner.
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Stella Maris Fabiane and Sharon B Love, UCL Innovative Clinical Trials Unit, Institute of Clinical Trials and Methodology, UCL, London, UK