Background Statistical methods for the analysis of harm outcomes in randomised controlled
trials (RCTs) are rarely used, and there is a reliance on simple approaches to display …

Biosimilars can provide choices for patients and may provide cost savings; however, their
uptake has been slow in the USA, in part due to limited knowledge. To provide additional …

Analyzing treatment harm is vital but problematic with the relatively small sample sizes
afforded in randomized controlled trials (RCTs). Good analysis practice for efficacy …

Abstract Background Randomised controlled trials (RCTs) provide valuable information and
inform the development of harm profiles of new treatments. Harms are typically assessed …

Objectives To gain a better understanding of current adverse event (AE) analysis practices
and the reasons for the lack of use of sophisticated statistical methods for AE data analysis …

Over the last few years, several review articles described the adverse events analysis as sub-
optimal in clinical trials. Indeed, the context surrounding adverse events analyses often …

Abstract Background Randomised controlled trials (RCTs) provide valuable information for
developing harm profiles but current analysis practices to detect between-group differences …

Background Globally, malaria is still a major public health challenge. Drug-based treatment
is the primary intervention in malaria control and elimination. However, optimal use of mass …

Background In drug trials, adverse events (AEs) burden can induce treatment non-
adherence or discontinuation. The non-adherence and discontinuation induce selection …

Despite the increasing awareness and guidance to support drug research and development
in the pregnant population, there is still a high unmet medical need and off‐label use in the …