Methodology

Abstract

Research integrity is now being redefined to require a higher level of methodological quality than has historically been the case. Innovations to reach this new standard fall into several categories: increased use of alternative trial designs with questions about how subject protection can be applied; need to move away from ‘P’ values and toward effect sizes in statistical analysis and full reporting of research methods including methods of analysis and modified endpoints. Driven by the recognition that the historically dominant standard of the randomized placebo-controlled trial (RCT) is not economically, politically, or scientifically always useful, new trial designs recognize the heterogeneity of disease, the need for timely answers in humanitarian emergencies or for the seriously ill, improvement in trial recruitment and receipt of appropriate treatment, and recognition of the need to synthesize information across trials.