On Wednesday 25 September the World Health Organization published new guidance to improve the design, conduct and oversight of clinical trials across the world.
The guidance aims to support what it calls strong ‘research and development ecosystems’ that create well designed and well implemented clinical trials.
These ecosystems are the building blocks and supporting mechanisms that enable clinical trials to be carried out quickly, safely and effectively.
To create these thriving ecosystems the guidance highlights some key building blocks, including a co-ordinated ethics review process, diversity of research participants, working in partnership with patients and communities in the design and delivery of research, and transparency of clinical trials.
Ethical approval and oversight
We were delighted to see the UK recognised as a country with a strong clinical trial infrastructure, with the Health Research Authority named in the report as an example of an organisation providing regulatory and ethics approval for research on health and social care.
Research Ethics Committees were recognised as an important part of the ethical oversight of health and social care research, in particular the steps they take to ensure the rights and welfare of participants are protected.
The guidance also recommends that for an effective review of clinical trials regulators need to work together and co-ordinate the approvals process. The Integrated Research Application System (IRAS) is highlighted as an example of this in practice.
“…the Health Research Authority in England is a national strategic research oversight body that promotes coordinated approaches to research review across the United Kingdom of Great Britain and Northern Ireland through its Integrated Research Application System (111). This is a single system for applying for the regulatory and ethics permissions and approvals for research on health and social care/ community care in the United Kingdom of Great Britain and Northern Ireland.”
The benefits of this joined up approach were summarised as:
“Harmonized clinical trial approval processes minimize unnecessary duplication, reduce delays and improve efficiency.”
Our work alongside the Medicines and Healthcare products Regulatory Agency (MHRA) demonstrates the strength of approach in the UK, with initiatives like Combined Review showing how a joined up approvals service can accelerate the set up of research.
The ‘rapid review’ of research during public health emergencies was also highlighted as an important part of the ethical review process. This is something that we saw clearly demonstrated during the COVID-19 pandemic, with the Fast-Track process seeing studies approved in as little as 48 hours.
Diversity and inclusion
One of the key recommendations made in the guidance is for the ‘limited diversity of participants’ in research to be addressed.
“…clinical trial cohorts have often lacked diversity, with under-representation of certain populations, resulting in them being underserved by clinical trials”
A number of areas where diversity and representation needs to be improved are highlighted in the guidance, including:
- age extremes (infants, children and older people)
- pregnant women
- ethnic minority groups
- stigmatized populations (including LGBTQI+ people)
- carers
- military veterans
- people who face language barriers
The HRA has championed diversity and inclusion in clinical trials in the UK.
We know that research that includes a diverse group of participants who are likely to be impacted by the outcome of research, including those who are traditionally underrepresented in research, will help reduce health inequalities.
We are currently consulting on guidance on how to increase the diversity and inclusion of research participants so that clinical trials get answers to problems facing the populations they are intended to benefit.
Working in partnership with patients and communities
Similarly to diversity and inclusion, working in partnership with patient and communities in the design and delivery of research is identified as an area that needs to be improved.
The guidance states that although this has improved, more needs to be done:
“(patient and community engagement) should be the norm and embedded in an appropriate manner in all trials; it is not an optional extra”
When describing the importance of patient and community engagement, the guidance states that if not done properly it can lead to:
“inappropriate trial design and implementation, mistrust in research, and failure of clinical trials to start, research completion or produce results meaningful to the populations they are intended to serve.”
Our Shared Commitment to Public Involvement campaign was launched in 2022 to address these very challenges in research carried out in the UK.
By involving a diverse range of people in the design and delivery of research we can earn and build trust.
Trust in the process will encourage more people to take part in research.
Transparency
Our ongoing work with the MHRA to update the UK Clinical Trials Regulations to ensure that we have proportionate regulation that legislates for transparency, closely aligns to what the WHO is calling for in this publication.
The guidance highlights the key phases of transparency as registration, making information about the trial publicly available, sharing results of research (trial reports) in a timely manner. These areas of focus match the priorities outlined in our research transparency strategy.
Clinical trials should be transparent in all of these areas, whether the results of a trial are deemed ‘good’ or ‘bad’.
Similarly to the aims of public involvement in research WHO’s guidance identifies trust as the ultimate aim of transparency.
“Transparency and sharing of knowledge about health care interventions help to generate further knowledge, build and maintain trust and give confidence to both those involved in the trial and those who are not.”
This guidance provides support for our work to improve the transparency of clinical trials carried out in the UK.
Our response to the guidance
Naho Yamazaki, Deputy Director of Policy and Partnerships at the Health Research Authority“We welcome the publication of the World Health Organization’s guidance on best practice for clinical trials: “Strengthening clinical trials to improve high quality evidence on health interventions and to improve research quality and co-ordination" and we have a part to play in meeting this in the UK.
“The UK has a strong clinical trial infrastructure and is a major contributor to the global clinical trial ecosystem. The HRA plays a key part in this, acting as a connector and enabler by managing research approvals and underpinning the work of others through our digital systems.
“And by enhancing research culture and practice, we help improve the UK’s ability to do world-leading health and social care research that people can trust.
“Our current work with the MHRA to update the UK’s clinical trials regulations will help establish a more proportionate, streamlined and effective clinical research system, which is aligned with what the WHO is calling for in this publication.
“We are also developing guidance, as part of our ongoing drive to embed meaningful public involvement in research and to push to increase the diversity and inclusion of research participants, so that clinical trials get answers to scientifically important questions relevant to the populations they are intended to benefit.”
Next steps
In this guidance the World Health Organization have provided a clear framework for the development of strong research ‘ecosystems’ across the world.
It is reassuring to see the UK named as an example of best practice when it comes to these ecosystems, and that we are seen as a major contributor to the wider global clinical trial ecosystem.
As we start work on developing our strategy for 2025 to 2028 this guidance will provide a clear evidence base for us to build on.