Methodology Research
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.
International Initiatives
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:
| Initiative | Description |
| 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:
| Initiative | Description |
| 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 Fellowships
We are involved in supervising and mentoring masters, pre-doctoral, doctorial and post-doctorial students and researchers within NDORMS and the wider University of Oxford on clinical and methodological research of relevance to clinical trials.
Current Projects
| Project | Funder | Student/Researcher |
| 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) |
|
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) |
| Complications following surgery for hip fracture | NIHR Doctoral Fellowship | En Lin Goh (Doctoral, University of Oxford) |
| Personal Fellowship | NIHR Developing Skills Enhancement Award | Anthony Gilbert (Post-doctoral Fellowship) |
| Personal Fellowship | NIHR Developing Skills Enhancement Award | Duncan Smith (Post-doctoral Fellowship) |
Completed Projects
| Project | Funder | Student/Researcher |
| 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) |
|
Understanding and Preventing Surgical Site Infection following Surgery for Hand and Wrist Trauma |
NIHR Doctoral Fellowship | Justin Wormald (Doctoral, University of Oxford) |
|
Personal Fellowship |
NIHR Developing Skills Enhancement Award | Howard Ryland (Post-doctoral Fellowship) |
|
Personal Fellowship |
NIHR Developing Skills Enhancement Award | David Keene (Post-doctoral Fellowship) |
Recent and Current Methodology Projects
We also conduct methodological research aimed at improving the design, conduct, analysis and reporting of clinical trials.
Please visit this link to see our publication list!