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Study protocol
Utilising Benefit-Risk Assessments within Clinical Trials – A Protocol for the BRAINS project
Nikki Totton
University of Sheffield
Corresponding Author
ORCiD: https://orcid.org/0000-0002-1900-2773
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background: 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.
Methods: 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,
4. Production of a guidance document.
Discussion: 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.
Keywords
Benefit-Risk, Randomised Controlled Trials, Health Technology Assessment
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Peer Review Timeline
CURRENT STATUS: Under Review
Version 3
Posted 10 Jan, 2021
No community comments so far
Reviewer #1 agreed
On 03 Jan, 2021
Review #1 received
Received 03 Jan, 2021
Reviewers invited
Invitations sent on 26 Dec, 2020
Editor assigned
On 21 Dec, 2020
Submission checks complete
On 21 Dec, 2020
No comments provided
Editorial decision: Minor revision
On 02 Dec, 2020
Reviewer #2 agreed
On 28 Nov, 2020
Review #2 received
Received 28 Nov, 2020
Review #1 received
Received 25 Nov, 2020
Reviewer #1 agreed
On 24 Nov, 2020
Reviewers invited
Invitations sent on 22 Nov, 2020
Editor assigned
On 18 Nov, 2020
Submission checks complete
On 18 Nov, 2020
No comments provided
Editorial decision: Minor revision
On 24 Oct, 2020
Review #2 received
Received 16 Oct, 2020
Reviewer #2 agreed
On 02 Oct, 2020
Review #1 received
Received 26 Jun, 2020
Reviewer #1 agreed
On 12 Jun, 2020
Reviewers invited
Invitations sent on 05 Jun, 2020
Editor assigned
On 19 Apr, 2020
Submission checks complete
On 14 Apr, 2020
First submitted
On 09 Mar, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
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This preprint is under consideration at Trials. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Study protocol
Utilising Benefit-Risk Assessments within Clinical Trials – A Protocol for the BRAINS project
Nikki Totton
University of Sheffield
Corresponding Author
ORCiD: https://orcid.org/0000-0002-1900-2773
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Under Review
Version 3
Posted 10 Jan, 2021
No community comments so far
Reviewer #1 agreed
On 03 Jan, 2021
Review #1 received
Received 03 Jan, 2021
Reviewers invited
Invitations sent on 26 Dec, 2020
Editor assigned
On 21 Dec, 2020
Submission checks complete
On 21 Dec, 2020
No comments provided
Editorial decision: Minor revision
On 02 Dec, 2020
Reviewer #2 agreed
On 28 Nov, 2020
Review #2 received
Received 28 Nov, 2020
Review #1 received
Received 25 Nov, 2020
Reviewer #1 agreed
On 24 Nov, 2020
Reviewers invited
Invitations sent on 22 Nov, 2020
Editor assigned
On 18 Nov, 2020
Submission checks complete
On 18 Nov, 2020
No comments provided
Editorial decision: Minor revision
On 24 Oct, 2020
Review #2 received
Received 16 Oct, 2020
Reviewer #2 agreed
On 02 Oct, 2020
Review #1 received
Received 26 Jun, 2020
Reviewer #1 agreed
On 12 Jun, 2020
Reviewers invited
Invitations sent on 05 Jun, 2020
Editor assigned
On 19 Apr, 2020
Submission checks complete
On 14 Apr, 2020
First submitted
On 09 Mar, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background: 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.
Methods: 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,
4. Production of a guidance document.
Discussion: 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.