It is possible to go further with the same dataset, by wanting to answer research questions that were not explored at the time of the CRO’s initial statistical analysis. New analyzes of the dataset are called secondary analyses.
They may focus on a subgroup of people, for example to assess the CRO’s benefit of treatment in people over 65 only, or people with diabetes, etc. Secondary analyzes can also answer completely new questions, by reusing all or part of the database, as in the sprint Challenge in 2016.
This challenge, organized by the scientific journal New England Journal of Medicine, proposed to explore the benefits of CRO’s data sharing by making the sprint trial database available with the aim of finding results that could improve medical knowledge.
The sprint trial compared intensive blood pressure management (goal pressure less than 120 mmHg) versus standard management (goal pressure less than 140 mmHg); the results concluded on the interest of intensive treatment.
This result is only true on the scale of a population: it is better to treat all of it than not at all. However, some individuals in this population may not benefit from intensive management. The secondary analyzes occasioned by the challenge notably enabled the design of a tool for identifying these people, making it possible to individualise the treatment as best as possible.