PATIENT EVIDENCE AND RESEARCH UNIT
INTRODUCTION
We envision a world where patients’ voices are not just heard but actively shape the future of healthcare for their communities. This vision is achievable through patient evidence. 
Patient evidence refers to the insights and data gathered directly from patients about their experiences, needs, preferences, and challenges related to healthcare and treatments. Unlike traditional clinical trial data, patient evidence reflects real-world experiences, providing a deeper understanding of how treatments and healthcare services perform across various demographics, health conditions, and lifestyles. This evidence is crucial for improving healthcare outcomes, addressing unmet patient needs, and ensuring that patient pathways are more inclusive and patient-centred. By integrating patient evidence, healthcare stakeholders, including pharmaceutical companies, regulators, and patient organisations, can develop more effective, accessible, and personalised treatment options that lead to better outcomes and a more responsive healthcare system.  

FOR PHARMACEUTICAL COMPANIES

Patient evidence offers pharmaceutical companies valuable insights beyond traditional clinical trials, capturing real-world data on patient needs, preferences, treatment experiences, and challenges. This evidence helps companies better understand the diverse patient populations often underrepresented in clinical studies, leading to more inclusive and tailored treatments. It also supports decision-making across the entire lifecycle of a drug, from development to post-market evaluation, helping with regulatory approval and reimbursement. By integrating patient evidence, pharmaceutical companies can create patient-centred solutions that improve efficacy, minimise risks, and ultimately drive better health outcomes. 

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FAQS

What is patient evidence?
Patient evidence refers to insights and data gathered directly from patients about their experiences, needs, preferences, and challenges related to healthcare and treatments. Unlike traditional clinical trial data, which often focuses on controlled environments and select populations, patient evidence reflects the real-world experiences of individuals across diverse demographics and health conditions. It includes valuable information on symptoms, quality of life, unmet needs, and treatment preferences.

Why does patient evidence matter?

Patient evidence is essential for improving healthcare outcomes by offering a deeper understanding of how treatments and services perform in real-world settings. It captures elements often missing from traditional research, addressing unmet needs and helping create more inclusive, patient-centred pathways. This evidence also reflects the perspectives of underrepresented patient groups, such as those with multiple comorbidities, caregivers, and individuals in rural or disadvantaged communities. For pharmaceutical companies, patient evidence informs decision-making throughout a treatment’s lifecycle—from development to post-launch—helping refine treatments, identify unmet needs, and demonstrate long-term safety and effectiveness. It also enables patient organisations to advocate for policy changes, shape research agendas, and ensure that patient voices are heard in healthcare decision-making.
Why should you generate patient evidence?
In a rapidly evolving healthcare landscape, patient evidence is key to shaping more effective, accessible, and personalised treatment options. This evidence identifies and addresses patients’ unmet needs across the diagnosis and treatment pathway, from timely diagnosis to psychological support, and access to clinical trials. Embracing patient evidence allows healthcare stakeholders to create solutions that lead to better outcomes, more efficient care, and a more responsive, patient-centred healthcare systems

Why is patient evidence important for patient organisations?

At Patvocates, we empower patient organisations by generating robust patient evidence that shapes healthcare decisions, policies, and research. Our core goals include: 

 

  • Ensuring a strong patient voice: Collecting reliable data on patient needs, preferences, and challenges to ensure their voice is heard in national and international discussions, influencing R&D and healthcare policies across disease areas. 
  • Securing patient representation in research: Integrating patient perspectives on access, treatment options, and outcomes into research, clinical trials, drug assessments, and regulatory decisions, ensuring real-world diversity is represented. 
  • Shaping research agendas: Helping patient organisations influence research priorities, particularly in areas of unmet need. 
  • Identifying barriers to care: Generating evidence on barriers to early diagnosis and timely treatment to advocate for changes in healthcare policies and practices. 
  • Maximising advocacy impact: Enhancing the ability of patient organisations to influence stakeholders at scientific, regulatory, and policy-making levels, ensuring patient-centred approaches are prioritised. 
Why is patient evidence important for pharmaceutical companies?
Patient evidence gathered outside traditional clinical trials provides pharmaceutical companies with valuable insights into how their products perform in real-world settings. It captures data on unmet needs, preferences, treatment experiences, and challenges, allowing companies to better understand the broader patient experience. Key benefits include: 

 

  • Diverse and representative data: Insights from underrepresented populations, such as those with comorbidities or in rural areas, help companies create more inclusive and tailored treatments. 
  • Supports decision-making across the product lifecycle: From early development to post-market evaluation, patient evidence informs regulatory approval, treatment refinement, and reimbursement negotiations. 
  • Informs regulatory and policy decisions: Reflecting real-world patient experiences, patient evidence accelerates drug approvals and shapes a more adaptive regulatory environment.
    By integrating patient evidence, pharmaceutical companies can create patient-centred solutions, enhance product efficacy, reduce side effects, and achieve better health outcomes. 
Who are the audiences for patient evidence?
To move the needle in addressing unmet needs, multiple stakeholders need to be persuaded by patient evidence to act.  

 

  • Research institutes integrate PED to develop more effective and tailored treatment options, to ensure that the research questions and outcomes are relevant to the patient community and to enhance the validity of research by including diverse patient perspectives. This makes research more applicable and trusted by the public.  
  • Pharmaceutical and biotech companies utilise patient evidence to prioritise efforts and refine drug development processes from pre-clinical to post-market phases. Based on patient evidence, they adapt their clinical trial designs, inclusion criteria, drug formulations, administration schedules, side effect management, marketing strategies and patient support programmes. Patient evidence helps in understanding how medications perform in everyday settings.  
  • Regulators, such as the EMA and FDA, advocate for integration of real-world patient evidence from the pre-approval stages to post-marketing surveillance. They use patient evidence to make regulatory processes more adaptive and responsive to patient needs and experiences, enhancing the relevance, safety and outcomes of medical and care interventions.  
  • Health technology assessment bodies and payers need to understand the burden of disease and how a treatment may alleviate that burden, i.e. the ‘value’ of treatment. To understand the lifelong effect of an intervention on quality of life, they need to understand the natural disease progression and how a treatment alters the course of progression. They also need to understand the (lack of) alternatives and the burden on caregivers. 
  • Healthcare professionals need to be made aware of treatment and care challenges and innovation or education that can overcome these challenges. Patient feedback concerning care services and patient care protocols can be a powerful way to highlight a need for change, for instance leading to protocol or guideline amendments. Moreover, patient preference research can create awareness concerning topics to factor in during shared decision-making. Systematic collecting of patient-reported outcomes supports the identification of factors contributing to successful treatment outcomes and can feed into decision making by sharing how other patients were faring during and after treatment. 
  • Patients and patient organisations need patient evidence to support them individually as well as collectively when creating awareness or advocating for change. To make the evidence tangible, it is important to put thought in how results are communicated both in presentation as well as via which channels. 
What is an Evidence Generation Unit for patient organisations and why is it important?
An Evidence Generation Unit is a structured, ongoing process for collecting patient data that ensures consistent, reliable insights into patient needs, preferences, and experiences. Unlike ad-hoc surveys, this unit enables patient organisations to respond dynamically to evolving patient needs. Key benefits include: 

      • Evidence-driven advocacy: Provides data to support advocacy, policy engagement, and research discussions. 
      • Real-time, tailored insights: Ensures continuous, up-to-date understanding of patient needs. 
      • Long-term impact: Builds a foundation for evidence-backed advocacy, strengthening your organisation’s future efforts. 
      • Increased credibility: Enhances your credibility by providing authoritative data that strengthens your position in healthcare policy discussions. 

This unit ensures that patient voices remain central in shaping healthcare decisions.

How can patient evidence be generated?
Patient evidence can be generated through structured data collection methods, including surveys, patient interviews, and real-time tracking of patient experiences throughout their healthcare journey. If you do not have the research skills or are uncertain what it takes, we are available to listen to your needs, provide you with advice, and, if desired, design and execute the research for you. For mature patient organisations, setting up an Evidence Generation Unit ensures consistent data collection, backing their advocacy by robust, real-time evidence. Collaboration with healthcare providers, pharmaceutical companies, and researchers can further enhance the depth and breadth of the evidence, ensuring that all relevant patient perspectives are included.
What challenges are associated with generating patient evidence?
While collecting patient evidence is invaluable, it comes with challenges such as ensuring data privacy, engaging diverse patient populations, and maintaining consistent data collection practices. Patient recruitment can be difficult, especially for underrepresented groups, and data collection must be designed to be accessible to all patients, regardless of location or background. However, with careful planning and collaboration, these challenges can be overcome, and the value of the evidence generated can significantly impact healthcare decision-making.