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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.

Ensuring that clinical trials are designed and executed to the highest methodological and ethical standards iStock
Ensuring that clinical trials are designed and executed to the highest methodological and ethical standards

We work closely with the Centre for Statistics in Medicine (CSM), which is co-located with the Unit, where statisticians are involved in a number of clinical trials with clinicians and other health care researchers in Oxford and further afield. The CSM also carries out methodological research relating to the design, conduct and reporting of studies of diagnosis, prognosis, and clinical trials and hosts the EQUATOR initiative.

At OCTRU we collaborate with a number of world class methodologists. Individuals within the OCTRU team also play a lead role in a number of international initiatives, including:

  • COMET (Core Outcome Measures in Effectiveness Trials): an initiative which brings together people interested in the development and application of agreed standardised sets of outcomes, known as ‘core outcome sets’ for clinical trials.
  • 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.
  • CONSORT (Consolidated Standards of Reporting Trials): an international initiative to alleviate the problems arising from inadequate reporting of randomised trials.
  • Trial Forge: an international initiative that aims to develop systematic approaches to make clinical trials more efficient.
  • PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses: an evidence-based minimum set of items for reporting in systematic reviews and meta-analyses of randomised 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.

Recent publications

Making research articles fit for purpose: structured reporting of key methods and findings.

Altman DG., (2015), Trials, 16

Specifying the target difference in the primary outcome for a randomised controlled trial: guidance for researchers.

Cook JA. et al, (2015), Trials, 16

Professional medical writing support improves the quality of reporting of randomized controlled trials

Gattrell W. et al, (2015), Current Medical Research and Opinion, 31, S20 - S20

Deficiencies in the publication and reporting of the results of systematic reviews presented at scientific medical conferences.

Hopewell S. et al, (2015), J Clin Epidemiol

Association between randomised trial evidence and global burden of disease: cross sectional study (Epidemiological Study of Randomized Trials--ESORT).

Emdin CA. et al, (2015), Bmj, 350

The PRISMA extension statement for reporting of systematic reviews incorporating network meta-analyses of health care interventions: checklist and explanations.

Hutton B. et al, (2015), Ann Intern Med, 162, 777 - 784

The CONSORT Statement: Application within and adaptations for orthodontic trials.

Pandis N. et al, (2015), Am J Orthod Dentofacial Orthop, 147, 663 - 679

Transparent Reporting of a Multivariable Prediction Model for Individual Prognosis or Diagnosis (TRIPOD): The TRIPOD Statement.

Collins GS. et al, (2015), Eur Urol, 67, 1142 - 1151

Association of cardiovascular trial registration with positive study findings: Epidemiological Study of Randomized Trials (ESORT).

Emdin C. et al, (2015), Jama Intern Med, 175, 304 - 307

The SPIRIT 2013 statement--defining standard protocol items for trials.

Agha RA. et al, (2015), Int J Surg, 13, 288 - 291

CONSORT extension for reporting N-of-1 trials (CENT) 2015 Statement.

Vohra S. et al, (2015), Bmj, 350

Impact of peer review on reports of randomised trials published in open peer review journals: retrospective before and after study.

Hopewell S. et al, (2014), Bmj, 349

Impact of spin in the abstracts of articles reporting results of randomized controlled trials in the field of cancer: the SPIIN randomized controlled trial.

Boutron I. et al, (2014), J Clin Oncol, 32, 4120 - 4126

Use of placebo controls in the evaluation of surgery: systematic review.

Wartolowska K. et al, (2014), Bmj, 348

Impact of adding a limitations section to abstracts of systematic reviews on readers' interpretation: a randomized controlled trial.

Yavchitz A. et al, (2014), Bmc Med Res Methodol, 14