Trial Conduct

Trial Conduct Working Group 

 

Trial Conduct

Scope

The Trial Conduct Working Group covers a wide range of aspects of trials. A Core Group, whose members represent each of the Hubs carrying out research into trial conduct as well as other important groups who are active in this field, meets regularly to facilitate and develop collaborative research into trial conduct. Recent activities have focussed on trial monitoring and the role of Trial Steering Committees. The latter includes new collaborative research which arose in response to issues raised in the HTMR’s engagement with one of our key stakeholders, the National Institute for Health Research Health Technology Assessment programme.

Future objectives

The Working Group will continue to focus on making trials more efficient and cost-effective, and in providing a link point between the HTMR Network and other organisations, including responding to recent consultations on the EU Clinical Trials Directive and access to data from trials. Its members are working on a variety of projects, including the SWAT (Study Within a Trial) programme, which was established by the All-Ireland Hub in 2012, along with its its sibling: Study Within A Review (SWAR).  It aims to facilitate the embedding of methodology research in clinical trials and other prospective studies, by providing free access to the outlines for numerous SWAT and details of those that have been carried out. The first SWAT outline was published in the Journal of Evidence Based Medicine in 2013, to investigate the impact of a site visit by the principal investigator in a multi-centre trial, and the findings were reported in 2015. The development of the SWAT collection was supported by an award from the Medical Research Council's Network of Hubs for Trials Methodology Research (MR/L004933/1-R50) in 2014 and a session at the 3rd International Clinical Trials Methodology Conference in November 2015 highlighted the initative and several examples. As of May 2016, more than 40 SWAT and SWAR have been registered with the Northern Ireland Hub. You can find their outlines, and information on how to register a SWAT or a SWAR, including an online form, at go.qub.ac.uk/SWAT-SWAR.

The Trial Conduct Working Group also support regular webinars.

 

MRC-NIHR TMRP Greener Trials Working Group Remit

Co-leads: Lisa Fox (Institute of Cancer Research) and further leads to be identified through Expression of Interest.

 

Objectives

The MRC-NIHR TMRP Greener Trials Working Group is a sub-group of the MRC-NIHR TMRP Trial Conduct Working Group. The overall aim of the Greener Trials Working Group is to facilitate networking and collaborative research in the area of environmentally sustainable clinical trials.

 

The working group aims to facilitate the consideration and uptake of more responsible research practise in clinical trials by providing a forum for the discussion of

  • Immediate operational opportunities for greener clinical trials;
  • How to disseminate and promote greener research practice in clinical trials;
  • The identification of challenges and barriers to the adoption of greener research practice;
  • The research agenda for assessing the potential relationship between lower carbon trial designs and trial efficiency and how to further develop this field of research.
  • Patient and public involvement and engagement activities to investigate patients’ views on carbon trade off decisions to inform the transition into routine practice.

Responsible research practises are considered any activity which may reduce the emissions, waste or water use of a clinical trial and as such the remit of this group can be applied to all MRC-NIHR TMRP Working Groups.

 

Potential research areas to target:

Operational opportunities for greener clinical trials - Further development, improvement and testing of the method to quantify the carbon footprint of clinical trials to inform future lower carbon clinical trial design. Development of guidance for trialists in greener trial management.

Disseminate and promote greener research practice in clinical trials - Promotion of guidance and training of CTUs to use the method at the design stage of trials via the development of webinars or workshops.

Identification of challenges and barriers to the adoption of greener research practice -Research to investigate behaviours. A forum for sharing of operational issues with greener research practise to share and facilitate solutions.

Development of a research agenda for assessing the potential relationship between lower carbon trial designs and trial efficiency and how to further develop this field of research - Discussion of ideas during the meetings and sharing of information between members. Development of collaborative projects and grant applications.

Patient and public involvement and engagement activities to investigate patients’ views on carbon trade off decisions to inform the transition into routine practice - Facilitate the conversation ofpatient views on the changes to trial conduct and participation made as a result of greener research practise to understand the impact it could have on patients.

 

Membership

The Trial Conduct Working Group will have a tiered approach to membership (with both full and associate members) allowing members to interact with the WG in ways appropriate for their interest. For example, full members will be actively involved in WG activities through the key areas or the core strategic group (made up of co-leads, target research area leads and PPI). Associate members may prefer to receive email updates and be invited to annual summary meetings.

The group should consider members that are included in (but not limited to) the groups outlined below:

  • Individuals with a professional interest in sustainability in clinical trials from an operational, methodological or sustainability background;
  • Patient partners and patient representatives;
  • International partners interested in clinical trial sustainability.

 

Collaborations

Collaborations for the Greener Trials Working Group will be explored at several levels: Within the immediate working group to explore opportunities to maximise collaborative activities within the new Greener Trials Group; Internally within the partnership – identify overlap with other working groups and reflect on opportunities for more responsible research (e.g. de-centralised and digital trial design adaptations); Externally – proactively engage with others out with the Partnership (both nationally and internationally) through activities such as webinars to scope potential for collaborative working. This will go beyond academic institutions and include opportunities with industry and regulatory bodies (e.g. MHRA, HRA), and others.