Background: As inclusion of raw data in Cochrane Reviews would increase the reliability of evidence, many stakeholder groups are demanding full transparency of clinical trials (CT). The effort to find a balance of trial transparency has recently intensified and many initiatives are taking place. This ongoing transition of CT data sharing would benefit from systematic analysis of such initiatives and their impact on clinical trials. Natural experiment or observatory is the methodology of choice for such a study.
Objectives:To present methodologies of the IMPACT Observatory that would monitor the impact of transitions in CT data sharing on CTs, and present the process involved in setting up the Observatory.
Methods: Observatories or natural experiments assess the impact of an intervention not controlled by the observatory researcher(s). They aim to inform and indicate trends. The establishment of the IMPACT Observatory included development of a methodology for assessing the impact on trials of data sharing interventions of different stakeholders, including: regulators; funders; journals; researchers; consumers; academia; and the pharmaceutical industry, as well as establishing a network of collaborators.
Results: The multiple pre and post measures will be used to assess the transition in data sharing over time (Table 1). Scoping review of literature combined with the survey established the baseline, set in 2000. The ongoing tendencies and transitions are measured by continuous analysis of the literature and websites, surveys, interviews, and by analysis of repositories. A network of collaborators has been developed and it will be routinely expanded.
Conclusions: The methodology of the IMPACT Observatory is well suited for the complex assessment of the impact of interventions in clinical trial data sharing by a number of stakeholders, while a network of collaborators is vital to ensuring its success and sustainability.