At the start of 2025, NICE updated its real-world evidence (RWE) framework on guidance for qualitative studies, showing NICE’s increasing openness to qualitative evidence submissions, particularly in rare conditions where RWE can be scarce. A new appendix dedicated to planning, conducting and reporting qualitative research to support NICE decision-making was introduced.

Why Qualitative Research Matters

Qualitative data provides a deep dive into lived experiences, beliefs, attitudes and social contexts—insights that quantitative methods alone cannot fully capture. Whether through interviews, focus groups or survey free-text responses, qualitative research offers invaluable perspectives that inform and enhance health technology evaluations and guideline development.

A Standard for Rigour and Transparency

NICE’s latest guidance ensures that qualitative research is conducted with the same level of rigour as other scientific methodologies. This means:

  • Clear Planning: Researchers must provide a rationale for their approach, justify sampling methods, and define their research aims upfront in a pre-specified protocol.
  • Stakeholder Involvement: Engaging with target populations and subject matter experts to refine research questions and discussion guides ensures relevance and reliability.
  • Researcher Bias & Transparency: Acknowledging the researcher’s role and potential biases enhances transparency and credibility.
  • Detailed Reporting: From data collection to analysis, studies should clearly outline their methodologies, ensuring reproducibility and trustworthiness.

And with outline best practices for:

  •  Ethical Conduct & Data Protection – Ensuring compliance with data protection laws and ethical approvals.
  • Sampling Strategies – Justifying participant selection to capture diverse perspectives while avoiding biases.
  • Robust Data Collection Methods – Selecting the right approach—interviews, focus groups, or surveys—to best answer the research question.
  • High-Quality Data Analysis – Applying rigorous analysis (NICE guidance selected thematic as one of most common), considering negative cases, and triangulating with other data sources.

Enhancing Real-World Evidence with Qualitative Research

Qualitative research plays a crucial role in enhancing real-world evidence by capturing patient, caregiver and sibling experiences that can be difficult to achieve via quantitative methods. When there are limited patient populations and challenges in conducting large-scale trials, qualitative methods offer deeper insights into disease burden, treatment impact and unmet needs such as:

  1. Capturing the patient & caregiver experience and revealing the emotional, social and functional impact of conditions, complementing clinical endpoints.
  2. Caregiver perspectives on disease progression, treatment burden, and quality of life provide valuable contextual data that RWE sources may overlook.
  3. Informing & Refining Clinical Outcomes with patient-reported insights from qualitative research can help develop new endpoints that better reflect what truly matters to patients.
  4. Enriching Economic Models with Lived Experience with qualitative methods to inform the development of health state vignettes, ensuring that cost-effectiveness models reflect real-world patient experiences rather than assumptions based solely on clinical data
  5. Understanding Treatment Access & Adherence Barriers. Qualitative research can uncover patient and caregiver concerns about treatment logistics, adherence, discontinuation and long-term expectations.

Shaping the Future of Evidence-Based Healthcare

This new appendix is part of NICE’s broader commitment to improving the quality and impact of real-world evidence. By setting a clear framework for qualitative research, NICE is ensuring that healthcare decisions reflect not just clinical efficacy, but also the voices of patients, caregivers, and professionals who experience healthcare firsthand.

Explore the full guidance and see how qualitative research can transform evidence-based healthcare decisions: Read More

For further information on Prime HCD’s qualitative research expertise, please contact Lesley.piltz@primeglobalpeople.com