Utilising benefit-risk assessments within clinical trials-a protocol for the BRAINS project

Totton, Nikki, Julious, Steven, Hughes, Dyfrig ORCID: 0000-0001-8247-7459, Cook, Jonathan, Biggs, Katie, Coates, Lizzie, Cook, Andrew, Hewitt, Catherine and Day, Simon
(2021) Utilising benefit-risk assessments within clinical trials-a protocol for the BRAINS project. TRIALS, 22 (1). 68-.

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<h4>Background</h4>Depending on the treatment to be investigated, a clinical trial could be designed to assess objectives of superiority, equivalence or non-inferiority. The design of the study is affected by many different elements including the control treatment, the primary outcome and associated relationships. In some studies, there could be more than one outcome of interest. In these situations, benefit-risk methodologies could be used to assess the outcomes simultaneously and consider the trade-off between the benefits against the risks of a treatment. Benefit-risk is used within the regulatory industry but seldom included within publicly funded clinical trials within the UK. This project aims to gain an expert consensus on how to select the appropriate trial design (e.g. superiority) and when to consider including benefit-risk methods.<h4>Methods</h4>The project will consist of four work packages: 1. A web-based survey to elicit current experiences and opinions, 2. A rapid literature review to assess any current recommendations, 3. A two-day consensus workshop to gain agreement on the recommendations, and 4. Production of a guidance document.<h4>Discussion</h4>The aim of the project is to provide a guideline for clinical researchers, grant funding bodies and reviewers for grant bodies for how to select the most appropriate trial design and when it is appropriate to consider using benefit-risk methods. The focus of the guideline will be on publicly funded trials however, the vision is that the work will be applicable across research settings and we will connect with other organisations and committees as appropriate.

Item Type: Article
Uncontrolled Keywords: Benefit-risk, Randomised controlled trials, Health technology assessment
Divisions: Faculty of Health and Life Sciences
Faculty of Health and Life Sciences > Institute of Systems, Molecular and Integrative Biology
Depositing User: Symplectic Admin
Date Deposited: 08 Jul 2021 09:15
Last Modified: 18 Jan 2023 21:36
DOI: 10.1186/s13063-021-05022-0
Open Access URL: https://doi.org/10.1186/s13063-021-05022-0
Related URLs:
URI: https://livrepository.liverpool.ac.uk/id/eprint/3129263