Our overarching aim is Improving Health by Improving Trials. Since its inception in 2009, the HTMR Network has strived to undertake cutting edge research in areas important to trials methodology.
By funding various projects and initiatives, we have contributed to publications, guidance documents, resources and recommendations for trialists. The resources below constitute the current recommended "Guidance Pack" (as April 2018).
The COMET initiative was launched in 2010 and supports the need for core outcome sets across a wide range of areas of health.
The COMET database contains information on published and ongoing core outcome set studies, and is regularly updated. The COMET initiative also supports workshops, presentations and meetings promoting the use of core outcome sets.
DIRUM is an open-access database of resource-use questionnaires for use by health economists involved in trial-based economic evaluations.
DIRUM also provides a repository of methodological papers related to resource use and cost measurement. At present, DIRUM contains over 70 instruments and is constantly being updated.
The CONSORT (CONsolidated Standards of Reporting Trials) 2010 guideline is intended to improve the reporting of parallel-group randomized controlled trial (RCT), enabling readers to understand a trial's design, conduct, analysis and interpretation, and to assess the validity of its results.
The 2013 CONSORT-PRO extension provides guidance for authors of trials describing patient-reported outcomes. Specifically, it extends five items of the CONSORT 2010 checklist to facilitate optimal reporting of RCTs in which PRO's are primary or secondary end points.
This Adaptive designs CONSORT Extension (ACE) to the CONSORT 2010 statement was developed to support the reporting of randomised trials that use an adaptive design. The ACE guideline was developed through a two-stage Delphi process with input from multidisciplinary key stakeholders.
The 2020 paper presents the ACE checklists for AD randomised trial reports and abstracts, as well as an explanation with examples to aid the application of the guideline.
The 2018 paper describes the development process of the ACE guideline.
On 10 December 2014, the HTMR Trial Conduct Working Group held a webinar presented by Dr Jemma Hopewell, Clinical Trial Service Unit, University of Oxford on the 'Monitoring trials efficiently: The role of central statistical monitoring
The video of the webinar can be viewed on the HTMR website.
This document summarises good practice principles for publicly funded CTUs to follow when sharing IPD and associated documentation from a clinical trial.
This guidance has been endorsed by Cancer Research UK, MRC Methodology Research Programme Advisory Group, Wellcome Trust and the Executive Group of the UK CRC Registered CTUs Network. The National Institute for Health Research (NIHR) has confirmed it is supportive of the application of this guidance.
The guidance is for all those who have a direct or indirect role in the funding, design, conduct and ethical review of paediatric or neonatal trials that involve critically ill children. This includes: doctors, nurses, paramedics, researchers, patient and public involvement (PPI) representatives, members of research ethics committees, funding committees, peer reviewers and Clinical Trial Unit (CTU) staff. The guidance will also be of interest to children and young people, trial sponsors, NHS Research and Development (R&D) staff, parents and other members of the public and to organisations that represent the interests of patients and the public.
MAMS trials have an important role to play in improving the efficiency of the drug development process when several experimental treatments are awaiting testing. this article we have considered a multitude of issues in the design of MAMS trials. This publication recommends the following points to be considered:
The guidance consists of 16 items within five domains: research questions, data collection, analysis, teamwork and reporting. Appropriate and well conducted qualitative research can make an important contribution to feasibility studies for randomised controlled trials. This guidance may help researchers to consider the full range of contributions that qualitative research can make in relation to their particular trial.The guidance may also help researchers and others to reflect on the utility of such qualitative research in practice, so that trial teams can decide when and how best to use these approaches in future studies.
This paper identifies key questions relevant to the design and reporting of surgical interventions in RCTs in surgery. The questions cover issues relating to intervention description, standardisation and monitoring, expertise of surgical teams, and the context of intervention delivery.
This paper provides practical guidance for surgeons and trialists to use when designing interventions in surgical RCTs to aid them in this process, so this information can be included a priori within trial protocols.
This guidance is designed to help UK-based Chief Investigators (CIs) of surgical trials to plan effective PPI to enhance the recruitment and retention of trial participants.
The guidance is based on the findings of PIRRIST (Patient and public Involvement to enhance Recruitment and Retention In Surgical Trials), a four-stage research project funded by the MRC HTMR Network, ConDuCT-II* and the NIHR Oxford Biomedical Research Centre
*MRC ConDuCT-II (COllaboration and iNnovation in DifficUlt or complex randomised Controlled Trials In Invasive procedures)
Queen's University Belfast host the Studies Within a Trial (SWAT) and Studies Within a Review (SWAR) initiatives, to show how methodology research might be embedded in healthcare research. The site includes a repository of existing SWAT and a form to register a SWAT outline
This work explored barriers to the routine implementation of methodology research around recruitment and retention, and highlighted important actions points: clarity from funders about the status of funding for SWATs; actions that send clear signals to trial teams and beyond about support for SWATs; and greater willingness from CIs and methodologists to discuss proposals for SWATs with funders prior to submission of a bid.
Rick et al. (2018)
Doing trials within trials: a qualitative study of stakeholder views on barriers and facilitators to the routine adoption of methodology research in clinical trials.
Biologic therapies are efficacious but costly. A number of health economic models have been developed to determine the most cost-effective way of using them in the treatment pathway.
These models have produced conflicting results, driven by differences in assumptions, model structure, and data, which undermine the credibility of funding decisions based on modeling studies.
A Consensus Working Party met to discuss recommendations and approaches for future models of treatment for rheumatoid arthritis.
The detailed roles and function of this executive committee, known as the Trial Steering Committee (TSC), have not previously been studied or reviewed since those originally proposed by the MRC in 1998. An expert panel was convened to discuss the roles and responsibilities of the TSC, and this paper presents recommendations that will contribute to update of the MRC TSC terms of reference.
This document summarises the main arguments why 3+3 and similar rule based A+B designs are inappropriate for phase I dose escalation studies. These designs are still widely used although superior model based designs such as the continual reassessment method (CRM) are available.
The aim of this work was to develop guidance regarding the selection and design of pilot and feasibility studies, including the development and assessment of progression criteria for internal pilot studies.
The first part of the work involved a review of current practice to provide insight into the process of designing and assessing internal pilot studies. The review showed that progression criteria are sometimes not met; however, committees involved in the reviewing process will recommend continuation to the main trial, usually accompanied by a second review or close monitoring. Recommendations are made to optimise the process (See publication below).
The second part of the work to develop guidance for when to do an external or internal pilot study is underway (please check back soon for further details).
A list of some external resources of use to trialists can be found here.