Today\'s surge of big data coming from multiple sources is raising the stakes that pharmacovigilance has to win, making evidence synthesis a more and more robust approach in the field. In this scenario, many scholars believe that new computational methods derived from data mining will effectively enhance the detection of early warning signals for adverse drug reactions, solving the gauntlets that post-marketing surveillance requires. This article highlights the need for a philosophical approach in order to fully realize a pharmacovigilance 2.0 revolution. A state of the art on evidence synthesis is presented, followed by the illustration of E-Synthesis, a Bayesian framework for causal assessment. Computational results regarding dose-response evidence are shown at the end of this article.

BACKGROUND: Home-based computerised cognitive training (CCT) is ineffective at enhancing global cognition, a key marker of cognitive ageing.
OBJECTIVE: To test the effectiveness of supervised, group-based, multidomain CCT on global cognition in older adults and to characterise the dose-response relationship during and after training.
METHODS: A randomised, double-blind, longitudinal, active-controlled trial.
METHODS: Community-based training centre in Sydney, Australia Participants: Eighty nondemented community-dwelling older adults (mean age = 72.1, 68.8% females) with multiple dementia risk factors but no major neuropsychiatric or sensory disorder. Of the 80 participants admitted to the study, 65 completed post-training assessment and 55 were followed up one year after training cessation.
METHODS: Thirty-six group-based sessions over three months of either CCT targeting memory, speed, attention, language and reasoning tasks, or active control training comprising audiovisual educational exercises.
METHODS: Primary outcome was change from baseline in global cognition as defined by a composite score of memory, speed and executive function. Secondary outcome was 15-month change in Bayer Activities of Daily Living from baseline to one year post-training.
RESULTS: Intention-to-treat analyses revealed significant effects on global cognition in the cognitive training group compared to active control after three weeks of training (ES = 0.33, P=.039) that increased after 3 months of training (ES = 0.49, P=.003) and persisted three months after training cessation (ES = 0.30, P=0.023). Significant and durable improvements were also noted in memory and processing speed. Dose-response characteristics differed among cognitive domains. Training effects waned gradually but residual gains were noted twelve months post-training. No significant effects on activities of daily living were noted and there were no adverse effects.
CONCLUSIONS: In older adults with multiple dementia risk factors, group-based CCT is a safe and effective intervention for enhancing overall cognition, memory and processing speed. Dose-response relationships vary for each cognitive domain, vital information for clinical and community implementation and further trial design.