Cross-sector surveys assessing perceptions of key stakeholders towards barriers, concerns and facilitators to the appropriate use of adaptive designs in confirmatory trials

Background Appropriately conducted adaptive designs (ADs) offer many potential advantages over conventional trials. They make better use of accruing data, potentially saving time, trial participants, and limited resources compared to conventional, fixed sample size designs. However, one can argue that ADs are not implemented as often as they should be, particularly in publicly funded confirmatory trials. This study explored barriers, concerns, and potential facilitators to the appropriate use of ADs in confirmatory trials among key stakeholders. Methods We conducted three cross-sectional, online parallel surveys between November 2014 and January 2015. The surveys were based upon findings drawn from in-depth interviews of key research stakeholders, predominantly in the UK, and targeted Clinical Trials Units (CTUs), public funders, and private sector organisations. Response rates were as follows: 30(55 %) UK CTUs, 17(68 %) private sector, and 86(41 %) public funders. A Rating Scale Model was used to rank barriers and concerns in order of perceived importance for prioritisation. Results Top-ranked barriers included the lack of bridge funding accessible to UK CTUs to support the design of ADs, limited practical implementation knowledge, preference for traditional mainstream designs, difficulties in marketing ADs to key stakeholders, time constraints to support ADs relative to competing priorities, lack of applied training, and insufficient access to case studies of undertaken ADs to facilitate practical learning and successful implementation. Associated practical complexities and inadequate data management infrastructure to support ADs were reported as more pronounced in the private sector. For funders of public research, the inadequate description of the rationale, scope, and decision-making criteria to guide the planned AD in grant proposals by researchers were all viewed as major obstacles. Conclusions There are still persistent and important perceptions of individual and organisational obstacles hampering the use of ADs in confirmatory trials research. Stakeholder perceptions about barriers are largely consistent across sectors, with a few exceptions that reflect differences in organisations’ funding structures, experiences and characterisation of study interventions. Most barriers appear connected to a lack of practical implementation knowledge and applied training, and limited access to case studies to facilitate practical learning. Keywords: Adaptive designs; flexible designs; barriers; surveys; confirmatory trials; Phase 3; clinical trials; early stopping; interim analyses

The Commonwealth, gender and peacekeeping

Reflecting on the strategic commitment outlined in the Plan of Action for Gender Equality (2005-2015) and the priority issues of the Commonwealth Women’s Forum, this article assesses the extent to which the Commonwealth as an institution is supporting troop and police-contributing member states in addressing the gender imbalance in peacekeeping operations. Drawing on desk-based research, interviews with international policymakers and a statistical analysis of the International Peace Institute Peacekeeping Database, the article first outlines the Commonwealth’s gender and security policy perspective before examining data sets to determine the success of Commonwealth member states in integrating women into uniformed peacekeeping contingencies between 2009 and 2015. The article observes that, in spite of a renewed optimism and drive to propel women into leadership positions in politics, the judiciary, public bodies and private companies, security sector reform and the implementation of pillar one of the UN Security Council Resolution 1325, is notably absent from the Commonwealth’s gender agenda. It is argued that this policy gap suggests that national and international security architecture is regarded as an accepted domain of masculine privilege. A lack of political will among Commonwealth Heads of Government to mainstream gender equality and facilitate structural transformation of national security organs, and a chronically under resourced Commonwealth Secretariat limits the influence of the institution to that of arms-length promoter of international norms on women, peace and security.