Sally Hopewell
MSc, DPhil
Professor of Clinical Trials and Evidence Synthesis
- Theme Lead for Clinical Trials
My key areas of research expertise are in the design, conduct and transparent reporting of randomized trials and systematic reviews. I have published (h-index 80) more than 300 research studies in these areas and have been instrumental in the development of key reporting guidelines including the CONSORT 2025 and SPIRIT 2025 Statements.
In my current role I am involved in leading the design and delivery of clinical trials within the OCTRU portfolio. I am co-chief investigator on several NIHR funded trials in the areas of paediatric and adult rehabilitation and musculoskeletal sciences and co-investigator on a number of other NIHR funded trials and evidence syntheses.
Previously, I worked at the Centre for Statistics in Medicine (2007 – 2015) on an MRC-funded programme of research related to CONSORT and the conduct and reporting of clinical trials. I also worked, and continue to collaborate with, the Centre d’Epidemiologie Clinique (2012 – present), University Paris Descartes, on research activities related to the methodology of systematic reviews and randomized trials. Prior to this I worked at the UK Cochrane Centre (2004 – 2012) and with the NHS National Blood Service (2010 – 2012) systematic review programme. In 2005, I was awarded a D.Phil at the University of Oxford on research into the effects of unpublished data in systematic reviews.
I have a particular interest in data sharing, development of core outcome sets, pilot and feasibility trials, paediatric trials and trials of complex interventions. I am a member of the NIHR Pre-Doctorial Fellowship funding panel, member of the advisory board for Current Controlled Trials, the NIHR Open Research Advisory Board, chair of the UKCRC CTU Network’s PPIE Group, and editor for the Cochrane Methodology Review Group editor. I was a member of the NIHR Health Technology Assessment Clinical Evaluation and Trials Board (2018 – 2022) and regularly carry out peer review for high impact medical journals and various funding bodies (e.g. NIHR and Medical Research Council)
I have considerable experience in the teaching and supervision of MSc and DPhil students both at the University of Oxford and Université Paris Descartes and previously for the London School of Hygiene and Tropical Medicine and Stellenbosch University in South Africa.
Recent publications
Identification and quantification of progression criteria in the design, conduct, and reporting of feasibility studies
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Mellor K. and Hopewell S., (2026), 139 - 149
Development of a set of core outcome measures for ambulant children with cerebral palsy after lower limb orthopaedic surgery.
Journal article
Almoajil H. et al, (2025), Dev Med Child Neurol
ligning SPIRIT and SAGER guidelines for equity in clinical trials - Authors' reply.
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Chan A-W. et al, (2025), Lancet, 406
Development of a PRISMA extension for systematic reviews of health economic evaluations (PRISMA-EconEval): a project protocol.
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Tran PB. et al, (2025), Syst Rev, 14
Threat of imposter participants in health research.
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Morrow E. et al, (2025), BMJ, 391
Reporting of environmental outcomes in randomised clinical trials: a protocol for a scoping review.
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Petersen JJ. et al, (2025), BMJ Open, 15
Tailored exercise management versus usual care for people aged 80 years or older with hip/knee osteoarthritis and comorbidities (TEMPO): multicentre feasibility randomised controlled trial in England.
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Nicolson PJA. et al, (2025), BMJ Open, 15
Protocol for development of SPIRIT and CONSORT extensions for reporting climate and environmental outcomes in randomised trials (SPIRIT-ICE and CONSORT-ICE).
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Petersen JJ. et al, (2025), BMJ Open, 15
Nonregistration, Discontinuation, and Nonpublication of Randomized Trials: A Systematic Review.
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Speich B. et al, (2025), JAMA Netw Open, 8
Metaresearch on patient-reported outcomes in trial protocols and results publications suggested large outcome reporting bias.
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Taji Heravi A. et al, (2025), J Clin Epidemiol, 185
Public availability of randomized clinical trial protocols: a repeated meta-research study.
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Schönenberger CM. et al, (2025), J Clin Epidemiol, 185
SPIRIT 2025 Statement: Updated Guideline for Protocols of Randomized Trials.
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Chan A-W. et al, (2025), JAMA, 334, 435 - 443
Development of START-EDI guidelines for reporting equality, diversity and inclusion in research: a study protocol.
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Fadel MG. et al, (2025), BMJ Open, 15
Do peer reviewers comment on reporting items as instructed by the journal? A secondary analysis of two randomized trials.
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Wnfried Ramirez H. et al, (2025), J Clin Epidemiol, 183
CONSORT 2025 statement: updated guideline for reporting randomized trials: a Korean translation.
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Hopewell S. et al, (2025), Ewha Med J, 48
CONSORT 2025 Statement: Updated Guideline for Reporting Randomized Trials.
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Hopewell S. et al, (2025), JAMA, 333, 1998 - 2005
SPIRIT 2025 statement: updated guideline for protocols of randomized trials.
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Chan A-W. et al, (2025), Nat Med, 31, 1784 - 1792
CONSORT 2025 statement: updated guideline for reporting randomized trials.
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Hopewell S. et al, (2025), Nat Med, 31, 1776 - 1783
Improving the completeness and transparency of protocols and reports of randomized trials: SPIRIT 2025 and CONSORT 2025.
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Moher D. et al, (2025), J Clin Epidemiol, 182
Clinical effectiveness of an individually tailored strengthening programme, including progressive resistance exercises and advice, compared to usual care for ambulant adolescents with spastic cerebral palsy (ROBUST trial): a parallel group randomized controlled trial.
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Hopewell S. et al, (2025), Bone Jt Open, 6, 517 - 527
Clinical effectiveness of a child-specific dynamic stretching programme, compared to usual care, for ambulant children with spastic cerebral palsy (SPELL trial): a parallel group randomized controlled trial.
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Theologis T. et al, (2025), Bone Jt Open, 6, 506 - 516
SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials.
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Hróbjartsson A. et al, (2025), BMJ, 389
SPIRIT 2025 statement: updated guideline for protocols of randomised trials.
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Chan A-W. et al, (2025), BMJ, 389
SPIRIT 2025 statement: updated guideline for protocols of randomised trials
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Chan A-W. et al, (2025), Lancet, 405, e19 - e27
CONSORT 2025 statement: updated guideline for reporting randomised trials.
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Hopewell S. et al, (2025), BMJ, 389
CONSORT 2025 statement: updated guideline for reporting randomised trials.
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Hopewell S. et al, (2025), Lancet
CONSORT 2025 explanation and elaboration: updated guideline for reporting randomised trials.
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Hopewell S. et al, (2025), BMJ, 389
Patient and public involvement in research reporting.
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Staniszewska S. et al, (2025), BMJ, 389
Describing the landscape of nutrition- and diet-related randomized controlled trials: metaresearch study of protocols published between 2012 and 2022.
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Silva FM. et al, (2025), Am J Clin Nutr, 121, 882 - 891
CONSORT 2025 statement: Updated guideline for reporting randomised trials.
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Hopewell S. et al, (2025), PLoS Med, 22
SPIRIT 2025 statement: Updated guideline for protocols of randomised trials.
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Chan A-W. et al, (2025), PLoS Med, 22
Integrating environmental outcomes in randomised clinical trials: a call to action.
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Petersen JJ. et al, (2025), Lancet, 405, 446 - 448
Guidance for protocol content and reporting of factorial randomised trials: explanation and elaboration of the CONSORT 2010 and SPIRIT 2013 extensions.
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Kahan BC. et al, (2025), BMJ, 388
CONSORT-DEFINE explanation and elaboration: recommendations for enhancing reporting quality and impact of early phase dose-finding clinical trials.
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Rekowski J. et al, (2025), EClinicalMedicine, 79
SPIRIT-DEFINE explanation and elaboration: recommendations for enhancing quality and impact of early phase dose-finding clinical trials protocols.
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Ursino M. et al, (2025), EClinicalMedicine, 79
SPIRIT 2025 Statement: updated guideline for protocols of randomised trials
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Chan AW. et al, (2025), Japanese Pharmacology and Therapeutics, 53, 1043 - 1055
CONSORT 2025 Statement:updated guideline for reporting randomized trials
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Hopewell S. et al, (2025), Japanese Pharmacology and Therapeutics, 53, 1031 - 1042
cross-sectional study assessing visual abstracts of randomized trials revealed inadequate reporting and high prevalence of spin.
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Duran M. et al, (2024), J Clin Epidemiol, 176
Pharmacological interventions for early-stage frozen shoulder: a systematic review and network meta-analysis.
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Berner JE. et al, (2024), Rheumatology (Oxford), 63, 3221 - 3233
Facilitating the transition from hospital to home after hip fracture surgery: a qualitative study from the HIP HELPER trial.
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Welsh A. et al, (2024), BMC Geriatr, 24
Reporting completeness of nutrition and diet-related randomised controlled trials protocols.
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Silva FM. et al, (2024), Clin Nutr, 43, 1626 - 1635
Reports of randomised control trials should begin and conclude with up-to-date systematic reviews of other relevant trials: a 25-year audit of the quality of trial reports.
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Clarke M. et al, (2024), J R Soc Med, 117, 212 - 216
Methods used to develop the SPIRIT 2024 and CONSORT 2024 Statements.
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Tunn R. et al, (2024), J Clin Epidemiol, 169
Anti-TNF (adalimumab) injection for the treatment of pain-predominant early-stage frozen shoulder: the Anti-Freaze-Feasibility randomised controlled trial.
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Hopewell S. et al, (2024), BMJ Open, 14
Development of a topic-specific bibliographic database supporting the updates of SPIRIT 2013 and CONSORT 2010.
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Østengaard L. et al, (2024), Cochrane Evid Synth Methods, 2
Feasibility of a comorbidity-tailored exercise and education intervention for people aged 80 years or older with hip or knee osteoarthritis
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Nicolson P. et al, (2024), Osteoarthritis and Cartilage, 32
FEASIBILITY OF A COMORBIDITY-TAILORED EXERCISE AND EDUCATION INTERVENTION FOR PEOPLE AGED 80 YEARS OR OLDER WITH HIP OR KNEE OSTEOARTHRITIS
Conference paper
Nicolson P. et al, (2024), OSTEOARTHRITIS AND CARTILAGE, 32, S536 - S536
Hospital-based caregiver intervention for people following hip fracture surgery (HIP HELPER): multicentre randomised controlled feasibility trial with embedded qualitative study in England.
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Smith TO. et al, (2023), BMJ Open, 13
Reporting of Factorial Randomized Trials: Extension of the CONSORT 2010 Statement.
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Kahan BC. et al, (2023), JAMA, 330, 2106 - 2114
Consensus Statement for Protocols of Factorial Randomized Trials: Extension of the SPIRIT 2013 Statement.
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Kahan BC. et al, (2023), JAMA Netw Open, 6
Perspectives of informal caregivers who support people following hip fracture surgery: a qualitative study embedded within the HIP HELPER feasibility trial.
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Welsh A. et al, (2023), BMJ Open, 13
Enhancing quality and impact of early phase dose-finding clinical trial protocols: SPIRIT Dose-finding Extension (SPIRIT-DEFINE) guidance.
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Yap C. et al, (2023), BMJ, 383
Enhancing reporting quality and impact of early phase dose-finding clinical trials: CONSORT Dose-finding Extension (CONSORT-DEFINE) guidance.
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Yap C. et al, (2023), BMJ, 383
Patient-Relevant Outcomes Following First Revision Total Knee Arthroplasty, by Diagnosis: An Analysis of Implant Survivorship, Mortality, Serious Medical Complications, and Patient-Reported Outcome Measures Utilizing the National Joint Registry Data Set.
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Sabah SA. et al, (2023), J Bone Joint Surg Am, 105, 1611 - 1621
Patient-relevant outcomes following elective, aseptic revision knee arthroplasty: a systematic review.
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Sabah SA. et al, (2023), Syst Rev, 12
Development of consensus-driven SPIRIT and CONSORT extensions for early phase dose-finding trials: the DEFINE study.
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Solovyeva O. et al, (2023), BMC Med, 21
Reminding Peer Reviewers of Reporting Guideline Items to Improve Completeness in Published Articles: Primary Results of 2 Randomized Trials.
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Speich B. et al, (2023), JAMA Netw Open, 6
Anti-TNF (adalimumab) injection for the treatment of adults with frozen shoulder during the pain predominant stage protocol for a multi-centre, randomised, double blind, parallel group, feasibility trial
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Hopewell S. et al, (2023), NIHR Open Research, 2, 28 - 28
Recommendations for progression criteria during external randomised pilot trial design, conduct, analysis and reporting.
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Mellor K. et al, (2023), Pilot Feasibility Stud, 9