About the ICR-CTSU

Greener Trials – decarbonising the delivery of health and social care research

Background

Whilst clinical trials are critical to identifying effective and safe treatments, they also have a significant environmental impact. Despite the first publication of a trial’s carbon footprint 16 years ago, there has been little action to consciously reduce carbon consumption of clinical trials, while the urgency of the threat from the climate crisis has increased exponentially.

Approximately 38,000 new trials were registered globally on Clinicaltrials.gov in 2022, with estimated carbon footprints of ~80 to over 2000 tonnes CO2 for a single trial. Clearly, clinical trials are an important but underexplored area to target for decarbonisation, whilst protecting health.

The ICR recognises the importance of fostering innovation to face global sustainability issues and at ICR-CTSU we are committed to reducing the environmental impact of trials and reducing the carbon footprint of our research.

We are part of the ICR’s Sustainability Advisory Steering Group, helping lead the development and implementation of the ICR’s sustainability strategy. We also contribute to the ICR’s ActNow sustainability working group which works across the ICR to help deliver initiatives and projects aligned with our sustainability strategy.

Current work

A collaboration between the Institute of Cancer Research – Clinical Trials and Statistics Unit (ICR-CTSU) and the University of Liverpool supported through NIHR funding has brought renewed activity and interest in this area through the development of the first iteration of a method and guidance to carbon footprint publicly funded clinical trials (doi:10.21203/rs.3.rs-2936937/v1). The work has been conducted in collaboration with other UKCRC Clinical Trials Units and the Sustainable Healthcare Coalition’s Low Carbon Clinical Trials Group. If you are interested in finding out more about carbon footprinting one of your trials, please contact the ICR-CTSU Carbon in Clinical Trials Team on [email protected].

Recognising the growing interest and support for this area of work, the NIHR MRC Trials Methodology Research Partnership recently established the Greener Trials group, lead by ICR-CTSU’s Assistant Operations Director, Lisa Fox. The multi-disciplinary group aims to develop the tools required to facilitate lower carbon clinical trials; work on a free online, publicly available eco-design tool for non-commercial research; to develop and disseminate greener research practice and facilitate collaboration between stakeholders to set the research agenda and drive the paradigm shift to lower carbon clinical trials. More details are available at: http://www.methodologyhubs.mrc.ac.uk/about/working-groups/trial-conductwg/.

The ICR-CTSU is committed to identifying ways to reduce the environmental impact of our work. In addition to the trial conduct and methodology work described above and engaging with the sustainability initiatives of the ICR as our host institution, we have established the ICR-CTSU Sustainability Working Group to consider how best we can apply local, national and sector-specific initiatives to our day to day work.

To date our group have introduced carbon footprinting of new ICR-CTSU trials at the funding application stage to try and inform lower carbon trial design, improved waste management, reduced single-use plastics, introduced various re-cycling initiatives and energy saving measures, engaged with sustainability initiatives such The Freezer Challenge and My Green Lab Ambassador Program and initiated projects to reduce consumable waste in our sample kit collections.

We also plan to work towards a de-centralised approach to clinical trials by, for example, employing remote and e-consent practices to reduce unnecessary patient travel and remote monitoring techniques to reduce ICR-CTSU team visits to participating sites.

To contact the ICR-CTSU Sustainability Working Group please email the team using [email protected].

As a university we use personally-identifiable information to conduct research to improve health, care and services. As a publicly-funded organisation, we have to ensure that it is in the public interest when we use personally-identifiable information from people who have agreed to take part in research.

This means that when you agree to take part in a research study, we will use your data in the ways needed to conduct and analyse the research study. Your rights to access, change or move your information are limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate.

If you withdraw from the study, we will keep the information about you that we have already obtained. To safeguard your rights, we will use the minimum personally-identifiable information possible.

Health and care research should serve the public interest, which means that we have to demonstrate that our research serves the interests of society as a whole. We do this by following the UK Policy Framework for Health and Social Care Research.

If you wish to raise a complaint on how we have handled your personal data, you can contact our Data Protection Officer who will investigate the matter. If you are not satisfied with our response or believe we are processing your personal data in a way that is not lawful you can complain to the Information Commissioner’s Office (ICO).

Our Data Protection Officer can be contacted at [email protected].

When you agree to take part in a research study, the information about your health and care may be provided to researchers running other research studies in this organisation and in other organisations.

These organisations may be universities, NHS organisations or companies involved in health and care research in this country or abroad. Your information will only be used by organisations and researchers to conduct research in accordance with the UK Policy Framework for Health and Social Care Research.

Your information could be used for research in any aspect of health or care, and could be combined with information about you from other sources held by researchers, the NHS or government.

Where this information could identify you, the information will be held securely with strict arrangements about who can access the information. The information will only be used for the purpose of health and care research, or to contact you about future opportunities to participate in research. It will not be used to make decisions about future services available to you, such as insurance.

Where there is a risk that you can be identified your data will only be used in research that has been independently reviewed by an ethics committee.

For more information on how we protect your data please view ICR’s Privacy Statement.

We have a dedicated operations team, led by our Operations Director Claire Snowdon and Assistant Operations Directors Lisa Fox and Alexa Gilman. Together they lead a team of trial conduct, data management and clinical trials IT experts.

Quality assurance

Our quality management system and dedicated quality assurance review team conduct a rolling programme of audit and process improvement. This ensures our procedures and systems are updated as required to reflect changes in clinical trials processes and regulations and are continually refined to improve efficiency in trial conduct and analysis.

We work closely with the UK’s Radiotherapy Trials Quality Assurance group to ensure that our trials of novel radiotherapy techniques are conducted to the highest possible standard, prioritising patient safety at all times.

Our Operations Director and Assistant Operations Directors sit on national and international groups and contribute to policy and regulation development to ensure that our expertise in efficient conduct of quality complex research is shared with the wider clinical trials community.

IT systems

Our dedicated team of clinical trial IT specialists maintain our clinical trials systems. MACRO is our clinical database used for electronic data capture directly from participating sites. MACRO is ICH GCP and FDA 21 CFR compliant. We work closely with the ICR’s specialist Information Governance team to ensure our processes and systems appropriately protect our participants’ confidentiality.

Secure file transfer

Large files may be transferred to our team via the ICR’s ZendTo service.

No identifying information about our trial participants should be sent to us via unencrypted email. The ICR’s recommended system for transferring patient identifying data is Egress.