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The processes for collecting, checking and analysing IPD are more involved and complex than for conventional aggregate data reviews of the same topic, and therefore, more time and resources are required (Chapter 3).^7,9,43 Thus, before embarking on an IPD project, careful consideration about whether it is an appropriate course of action is needed (Section 2.6).^47,49

As most IPD projects rely on collaboration with the teams responsible for the included trials, negotiating and maintaining relationships with investigators from different countries, settings and disciplines can take considerable time, effort, diplomacy and careful management (Section 3.2.1).^43,44 In an era in which the value of clinical data sharing is more widely appreciated, persuading trial investigators of the value of participating has perhaps become easier. That said, IPD meta‐analysis research teams and those providing IPD are now faced with additional tasks, such as seeking ethical or other institutional approval for the exchange of IPD (Section 3.10), as well the development of detailed data‐sharing agreements (Section 3.11).

Over the years, advances in database and statistical software and electronic communication have greatly reduced the burden of labour required for the data exchange, management and analysis aspects of IPD projects.⁴³ Even so, these remain the most time‐consuming and resource‐intensive phases (Section 3.8), and require skills and expertise beyond those needed for a conventional aggregate data review (Section 3.5). This is emphasised by a growing number of methodological articles relating to IPD meta‐analysis projects, covering issues such as data checking and harmonisation,^7,28 statistical methodology,^33,50–57 examining potential biases,^46,58 dealing with unavailable IPD,⁵⁹ reporting,⁶⁰ and statistical software development,⁶¹ amongst others.