As part of OCTRU’s goal to ensure that clinical trials are designed and executed to the highest methodological and ethical standards, we participate in, and lead, methodological research of relevance to clinical trials. This also ensures that OCTRU gains and retains a position of leadership in the field, and is recognised internationally as a focus for high quality clinical trial design, conduct and reporting.
Individuals within the OCTRU team play a lead role in a number of international initiatives aimed at improving the design, conduct and reporting of clinical trials, including:
|CONSORT||Consolidated Standards of Reporting Trials: an international initiative to alleviate the problems arising from inadequate reporting of randomised controlled trials. An update of CONSORT 2010 and to combine with SPIRIT is currently in progress.|
|SPIRIT||Standard Protocol Items: Recommendations for Interventional Trials: an international initiative that aims to improve the quality of clinical trial protocols by defining an evidence-based set of items to address in a protocol. An update of SPIRIT and to combine with CONSORT 2010 is currently in progress.|
|DELTA2||Guidance on reporting target difference and sample size calculations for randomised controlled trials.|
|EQUATOR||Enhancing the QUAlity and Transparency Of health Research Network: an international initiative that seeks to improve the reliability and value of published health research literature by promoting transparent and accurate reporting and wider use of robust reporting guidelines.|
|COCHRANE ROB-2||Risk of Bias-2 tool: an international initiative to develop a tool to assess the risk of bias in randomised trials included in systematic reviews.|
National and Local Initiatives
Individuals within the OCTRU team also play a lead role in a number of national and local initiatives aimed at improving the design, conduct and reporting of clinical trials, including:
|MRC Trial Methodology Research Partnership||A network of UK, institutions and partners working in trials and trials methodology research aimed at advancing trial methodology, developing capacity and further reducing research waste.|
|UKCRC Registered Trials Network||Developing Statistics specific GCP training.|
|PRincipleS for handling end-of-participation EVEnts in clincial trials REsearch (PeRSEVERE)||How the right to withdraw informed consent in research should be put into practice.|
|NIHR HTA Clinical Evaluation and Trials Record||NIHR funding committee for clinical evaluation and trials.|
Students and Fellowship
We are involved in supervising post-doctoral, doctorial and pre-doctorial researchers within NDORMS and the University of Oxford more broadly, conducting methodological research of relevance to clinical trials.
|Individualised progressive exercise versus supported self-management for people after acute patellar disclocation: a multi-centre feasibility randomised controlled trial with an embedded qualitative study||NIHR Doctoral Fellowship||Colin Forde (Doctoral)|
Understanding and Preventing Surgical Site Infection following Surgery for Hand and Wrist Trauma
|Justin Wormald (Doctoral, University of Oxford)|
Surgery Or REstraint for the unexplained painful knee replacement (the sore KNEE Study): Patient, Clinical and Cost Effectiveness Considerations
|NIHR Doctoral Fellowship||Shiraz Sabah (Doctoral, University of Oxford)|
Non-invasive Electrical Stimulation to Augment Human Peripheral Nerve Regeneration in Carpal Tunnel Syndrome
|MRC Clinical Research Training Fellowship||Max Stewart (Doctoral, University of Oxford)|
A mixed-methods study evaluating the feasibility of a future multi-centre definitive randomised controlled trial comparing no-mesh to mesh-assisted breast reconstruction surgery
|NIHR Doctoral Fellowship||Rachel Rolph (Doctoral, University of Oxford)|
Development of a Core Outcome Set for Children's Elective Lower Limb Orthopaedic Surgery
|NIHR Doctoral Clinical and Practitioner Academic Fellowship||Eileen Morrow (Doctoral, University of Oxford)|
|Enhancing the transparency and communication of the results of randomised trials to research participants and the public||Clarendon NDORMS departmental scholarship||Sanjana Choudhury (Doctoral, University of Oxford)|
|Improving the reporting in randomised clinical trials through observational and interventional research: From study protocols and registries to full text publications||Swiss National Science Foundation||Beni Speich (Post-doctoral Fellowship, University of Oxford)|
|Development of a Novel Outcome Measure for Forensic Psychiatric Services||NIHR Doctoral Fellowship||Howard Ryland (Doctoral, University of Oxford)|
|Improving the specification of the target difference in the sample size calculation of a randomised trial of treatments in osteoarthritis||EPSRC (Engineering and Physical Sciences Research Council) doctoral studentship||Bethan Copsey (Doctoral, University of Oxford)|
|Addressing challenges in the design, analysis and reporting of factorial randomised controlled trials||NIHR Pre-doctoral Fellowship||Ioana Marian (Pre-doctoral, University of Oxford)|
|Development of a Core Outcome Set for Elective Paediatric Lower Limb Orthopaedic Surgery||NIHR Pre-doctoral Fellowship||Eileen Morrow (Pre-doctoral Fellowship, University of Oxford|
|Investigating the use of pre-specified criteria to inform progression from a randomised pilot study to a definitive randomised controlled trial||Oxford MRC-DTP Studentship||Katie Mellor (Doctoral, University of Oxford)|
|Developing a core outcome sets for lower limb orthopaedic surgery for ambulant children with Cerebral Palsy||Hajar Almoajil (Doctoral, University of Oxford)|
|Assessing the generalisability of trial findings using large orthopaedic population studies||NIHR Pre-doctoral Fellowship||Dongquan Bi (Pre-doctoral, University of Oxford)|
Recent and Current Methodology Projects
We also conduct methodological research aimed at improving the design, conduct and reporting of clinical trials.
Please visit this link to see our publication list!
the SPIRIT (2013) and CONSORT (2010) reporting guidelines update project
Randomised controlled trials provide the best evidence of the effectiveness (and harms) of health care interventions and are a crucial part of evidence-based health care. The SPIRIT and CONSORT Statements help researchers to report their trial protocols and results transparently and completely. This is important so that readers can critically evaluate the evidence and make informed decisions. SPIRIT 2013 and CONSORT 2010 are being updated to reflect new evidence and opinions. You can read more about the update project in a recent Comment article published in Nature Medicine.
This project is being led by the SPIRIT–CONSORT Executive Group. The project is funded by the MRC-NIHR: Better Methods, Better Research [MR/W020483/1]. The Principal Investigator is Prof Sally Hopewell (University of Oxford), and the study investigators are: Prof Isabelle Boutron (Université Paris Cité), Prof An-Wen Chan (University of Toronto), Prof Gary Collins (University of Oxford), Prof Asbjørn Hróbjartsson (University of Southern Denmark), Prof David Moher (University of Ottawa), Prof Kenneth F Schulz (University of North Carolina at Chapel Hill). The research co-ordinator is Dr Ruth Tunn (University of Oxford).
We are conducting a Delphi survey to inform an update of the SPIRIT (2013) and CONSORT (2010) statements. We are consulting the following stakeholder groups:
- Researchers with expertise in trial design and methodology
- Assessors/approvers of trials
- Commissioners of trial grants
- Users of SPIRIT and CONSORT guidelines
- Consumers of trial results
The sign-up portal has now closed. Thank you to everyone who volunteered to participate!
The expected dates of the survey are:
Round 1 is open for responses and will close at 11:59pm on Monday 31st October
Round 2: November–December 2022
Round 3 (if needed): January–February 2023
These dates may change subject to the progress of the study.
Delphi participants provide a vital contribution to this research; however, Delphi participation alone does not satisfy ICMJE authorship criteria so please be advised that participants will not receive authorship credit on the ensuing publications.
The SPIRIT–CONSORT Executive Group