Quality statement 8: Clinical research
Quality statement
People with a rare disease are offered the opportunity to take part in clinical research, if available and they are eligible.
Rationale
Barriers to accessing clinical research can be greater for those people with a rare disease who do not have access to specialist centres and multidisciplinary teams. Measuring participation in clinical research will help improve equitable access. Healthcare providers, specialist centres and networks should identify relevant active research on rare diseases and help the person make an informed choice about whether or not to take part in research.
Quality measures
The following measures may be useful to support assurance and improvement. They are examples of how the statement could be measured but may require adaption depending on local, regional and national commissioning arrangements.
Structure
Evidence of arrangements to ensure that people with a rare disease are assessed for eligibility for relevant clinical research and offered the opportunity to take part.
Data source: Data may need to be collected at local service, specialist service or network level depending on the commissioning arrangements.
Process
The proportion of people with a rare disease and eligible for clinical research who are offered the opportunity to take part.
Numerator – the number in the denominator offered the opportunity to take part.
Denominator – the number of people with a rare disease and eligible for clinical research.
Data source: Data may need to be collected at local service, specialist service or network level depending on the commissioning arrangements.
What the quality statement means for different audiences
Service providers (secondary and tertiary care providers) ensure that multidisciplinary teams discuss whether people with a rare disease are eligible for any clinical research and, if they are, promote participation in the research.
Healthcare professionals (such as doctors, nurses and allied health professionals) identify relevant clinical research for people with a rare disease, assess eligibility and offer opportunities to take part.
Commissioners ensure that the services they commission for people with a rare disease identify relevant clinical research and support participation.
People with a rare disease are offered the opportunity to take part in clinical research that has been identified as suitable for them and are supported to participate.
Source guidance
Improving outcomes in children and young people with cancer. NICE guideline CSG7 (2005), psychosocial care: page 123.
The Department of Health and Social Care's England Rare Diseases Action Plan 2025 recognised the need to improve access to research for people with rare diseases based on data from the NIHR's Be Part of Research Platform. Steps have been taken to increase the number of rare conditions included on the platform and the number of relevant clinical trials available. The measures in this statement will aim to increase this further. Other local actions will also improve access to research.
Equality and diversity considerations
People should be supported to overcome potential difficulties in participating in clinical research, which may result from the person having to travel a long way to attend appointments, or from them having a disability, cognitive difficulties, or financial barriers. Proactive measures should be used to improve participation in research among under-represented groups. Information provided as part of discussions should be age-appropriate and meet accessibility needs.