Patient-Centred Solutions Flashcards
Understand what the PCS team does and what type of work they
What is patient centricity?
Patient-centricity is designing healthcare solutions that prioritize patient needs, preferences, and values to improve outcomes and experiences.
- Involving patients as active participants in their care.
- Incorporating the patient voice throughout the drug development lifecycle.
- Focusing on outcomes that matter most to patients (e.g., quality of life, symptom relief).
What are 3 reasons why it is important to involve patients in their care?
- Improves patient adherence and satisfaction.
- Increases clinical trial enrollment and retention.
- Aligns with regulatory requirements and market access strategies.
2 examples of patient-centricity in action
- Using patient-reported outcomes (PROs) in clinical trials.
- Co-designing treatment protocols with patient advocacy groups.
3 examples of qualitative patient experience data
- Interviews
- ocus groups
- Ethnographic studies.
3 examples of quantitative patient experience data
- Patient-reported outcome measures (PROMs)
- Surveys
- Preference studies.
3 examples of passive patient experience data
- Wearables
- Digital health tools
- Real-world evidence (RWE).
What are 3 emerging trends in patient centricity?
- Increasing use of real-world evidence (RWE) to capture patient experiences.
- Integration of digital health tools in clinical trials.
- Personalized medicine and targeted therapies.
What are 3 challenges in patient-centricity?
- Balancing patient needs with regulatory requirements.
- Addressing health literacy and accessibility barriers.
- Ensuring diversity and inclusion in patient research.
How would you incorporate the patient voice into a clinical trial design?
- Engage patients early and often (patient advisory panels, focus groups, interviews)
- Define meaningful outcomes that reflect patient perspectives
- Simplify participation (trial design, eligibility criteria, informed consent)
- Enhance communication and support (patient-friendly materials, feedback mechanisms, support services like transportation assistance)
- Use patient-reported outcomes and real world evidence
- Ensure diversity and inclusion
- Co-create with patients
- Transparency and results sharing to foster trust
How would you approach a project focused on understanding patient preferences for a new therapy?
- Define objectives and scope; understand the purpose of the project (regulatory submission, inform pricing, shape clinical development), and align with stakeholders on what will be explored
- Conduct background research; literature review (existing studies, patient reported outcomes, real world evidence), competitor analysis, engage advocacy groups
- Design a Mixed-Methods Research Approach; qualitative (focus groups/interviews) and quantitative (discrete choice experiments or conjoint analysis to quantify trade-offs, use surveys to validate findings for large population)
- Ensure diversity, inclusion, and representative sampling
- Potentially use social listening to analyse patient discussions on forums or social media
- Analyze and interpret findings
- Translate findings into recommendations based on objective (e.g. clinical development, regulatory adn market access, patient engagement)
What are 4 sources of real world data?
- Electronic and paper medical records, hospital administrative systems
- Prescribing databases
- Claims databases
- Registries
What are some ways to close evidence gaps?
- Leveraging real-world evidence
- Conducting systematic review and meta-analyses
- Collaboration with academics and clinical experts
- Using longitudinal data to track patient outcomes over time
- Modelling and forecasting
- Patient-centred research using patient reported outcomes and preference studies
- Collaborating with other agencies/organisations
- Surveys
What does the PCS team do?
Measuring patient experience of disease and treatment
- Strategy development
- Validation and implementation of clinical outcome assessments
- Regulatory and payer strategy
- Design and conduct qualitative and quantitative patient experience data studies (patient interview studies - standalone and in clinical trials, mixed methods studies, patient preference and quality of life studies)
What are 2 important regulatory bodies in COA?
- FDA
- European Medicines Agency (EMA)
How is real world data (RWD) used?
Used to help regulators and payers to understand the context, clinical impact and economic impact of new therapies, esp. for rare conditions
Why do companies use RWD?
Companies that use RWD gain more regulator and payer approval than those who did not. Also have great uptake post launch, multi-country adoption, and greater overall revenue.
What are the pros of using Electronic and paper medical records, hospital administrative systems as a source of RWD?
- Detailed snapshots of clinical care
- Can be highly specialised
- Provide comprehensive information on diseases that might be managed at a single site – whether primary care or a specialist hospital.
- EMR updated daily
What are the cons of using Electronic and paper medical records, hospital administrative systems as a source of RWD?
- When patients are moving through multiple settings, it may be more helpful to use claims data and longitudinal prescription data (tracks and measures new, switch and repeat prescriptions, to give the prescription dynamics in a given therapy market)
- Not all specialities may be captured
- Information on patient experience may not be captured
- Costs typically not recorded
- Long-term outcomes not reported
- Hospital administrative systems may only be refreshed monthly or annually
What do prescribing databases cover?
- National scale overview of drug use
- Monitor drug dispensing from retail pharmacies
What are the pros of using prescribing databases as a source of RWD?
- Capture patient demographic and details on drug dosing and duration across a large number of patients
- Captures drug treatment patterns
- Updated on a monthly to quarterly basis, which is more readily accessible than other forms of RWD
What are the cons of using prescribing databases as a source of RWD?
- Doesn’t provide detail on clinical care, clincal context, patient characteristics, or outcomes
- Primary care and secondary care prescribing are often recorded separately. Following a patient between community and hospital may need to be supplemented by a robust claims dataset.
What do claims databases capture?
- Claims records capture activities for which they will be paid; diagnostic tests, interventional
procedures, drugs, and hospital stays. Claims records also capture some patient details to support accurate accounting - Differences between data submitted by clinicians to payers (medical claims or pre-adjudicated claims) and the final review and approved set of claims from the payer (adjudicated claims)
What are the pros of using claims databases as a source of RWD?
- Typically large population
- Good for treatments, HC utilisation, and cost of care
- Records patient journey , in come cases across primary and secondary care
What are the cons of using claims databases as a source of RWD?
- Do not have the depth of clinical information found in an EMR system
- e.g. a claims system records the date of treatment and the cost, EMR records the date of treatment and the result, but not the cost
- Lots of things affect how representative the data is: the number of patients covered by the payer, the care setting (primary vs secondary), geography (regional, national, hospital-level)
