Virologic effects of broadly neutralizing antibodies VRC01LS and VRC07-523LS on chronic HIV-1 infection.

BACKGROUNDHIV-1-specific broadly neutralizing monoclonal antibodies (bNAbs) have emerged as promising interventions with the potential to effectively treat and prevent HIV-1 infections. We conducted a phase I clinical trial evaluating the potent CD4-binding site-specific (CD4bs-specific) bNAbs VRC01LS and VRC07-523LS in people with HIV-1 (PWH) not receiving antiretroviral therapy (ART).METHODSParticipants received a single intravenous 40 mg/kg dose of either VRC01LS (n = 7) or VRC07-523LS (n = 9) and did not initiate ART for a minimum of 14 days.

Is my project research? Determining which projects require review by a research ethics committee.

Background: Deciding which types of activities require an ethics review is a critical component of research regulation. Reviews conducted by research ethics committees consider the rights and safety of potential research participants, and occur as part of a wider set of governance reviews. However, to save time and resources, projects that do not raise ethical issues, or have ethical issues dealt with through other processes, are defined as out of scope for research ethics review by often being labelled as quality improvement, clinical service evaluation, audit or similar.

The collaborative working group method for pre-trial knowledge mobilisation: a qualitative evaluation of a structured process for iteratively refining a complex intervention (DAFNEplus).

Background: There is a lack of practical guidance about how to effectively mobilise knowledge at the pre-trial stage. Despite increased guidance on developing complex interventions in recent years, much of this focuses on the theory and principles behind high-quality intervention development, rather than the practical aspects of how this should be achieved. This paper shares the findings from an embedded, qualitative evaluation of the Collaborative Working Group (CWG) process, a structured approach we developed to iteratively refine a complex intervention prior to a randomised controlled trial.

A review of UK publicly funded non-inferiority trials: is the design more inferior than it should be?

Background: The number of non-inferiority (NI) trials, those aiming to show a new treatment is no worse than a comparator, is increasing. However, their added complexity over superiority trials can create confusion. Most guidance and reviews to date have an industry focus with research suggesting these trials may differ from publicly funded NI trials.

Acceptability and psychometric properties of four scales assessing the impact of Type 2 diabetes on quality of life-Results of 'YourSAY: Quality of Life'.

Aims: To assess and compare the psychometric properties and acceptability of four diabetes-specific quality of life (QoL) scales among adults with Type 2 diabetes (T2D).

Methods: Adults (≥18 years) with T2D living in the United Kingdom (n = 1465) or Australia (n = 248) completed a cross-sectional, online survey including the following: ADDQoL, DCP, DIDP and Diabetes QoL-Q (presented in randomised order), followed by rating scales to assess clarity, relevance, ease of completion, length and comprehensiveness of each scale. Demographic, clinical and psychosocial characteristics were collected.