Methods for capturing the patient's voice and payers' perspectives have drastically changed.
Reflecting on 2020
The global pandemic affected how research was conducted in the health economics and outcomes research (HEOR) world. The ICON global HEOR team paused, regrouped, and pivoted to adapt to the changing environment brought on by this pandemic. Capturing both the patient voice and the payer perspective is crucial to a successful drug development program. However, in the setting of a global pandemic, how those voices are being captured had to drastically change.
Face-to-face interviews and focus groups with patients were no longer possible in a world in lockdown. In-person advisory board meetings and interviews with HTA representatives were no longer viable options. Administering clinical outcomes assessments (COAs) to patients during site visits suddenly became impossible, or at least, much more challenging. Additionally, processes related to HTA appraisals and clinical trial programs were delayed in some therapeutic areas, partly as a result of re-prioritizing resources in the race to control the pandemic. Professional conferences, which usually serves as an opportunity to meet and interact with peers in the field, were cancelled or switched to virtual settings, limiting our ability to interact with global colleagues.
However, despite these challenges of living in a pandemic world, our effort to bring new innovative products to market goes on. Evidence planning and generation still needed to be done. Patient-reported outcomes (PRO) data still needed to be collected, health economic evidence still needed to be generated and health technology assessments albeit after a short hiatus still continued. The work of drug development and engaging with patients and payers has to continue. However, the way health economics and outcomes research takes place had to be reassessed and reinvented in 2020.
When in-person research became nearly impossible, innovation through technology stepped in to ensure that the patient and payer voice would still be heard. Through the use of videoconference platforms, our patient interviews and focus groups became virtual, allowing our global HEOR researchers to connect with patients in their own living rooms, at their convenience. Similarly, virtual advisory boards and payer interviews enabled us to talk to payers across the globe without the added expense and time associated with travel. The global HEOR team worked closely with our clients to help manage their shifting priorities and timelines, and adapt to their needs. We also organised multiple webinars and attended many virtual professional conferences to stay connected and continue sharing novel research methodologies and findings with our peers.
Looking ahead in 2021
Looking ahead in 2021, the GHEOR team continues to evolve, adapt and define the “new normal” in the world of health economics and outcomes research. In 2020, COA experts were called upon to help drug development programs rethink their COA data collection methods. The trend towards completely remote COA data collection continues into 2021, as the pandemic continues. That is, there is increased use of electronic COA (eCOA), and a rising trend in the use of BYOD (bring your own device).
Also, traditionally, the patient and caregiver voice within the context of clinical trials has been limited to the data collected through COAs. However, more recent trends are indicating that the inclusion of qualitative research within the context of clinical trials through embedded interviews and mixed methods research is becoming increasingly more common. This more holistic approach to incorporating the patient/caregiver voice in drug development is looked upon favourably by regulatory bodies, such as the FDA.
Advisory board meetings and other traditional face-to-face meetings continue to be held successfully as remote virtual meetings. We are looking forward to sharing our knowledge and expertise through many exciting upcoming presentations and webinars in 2021.
Meanwhile, other world events and trends impact the HEOR world. There are new HTA processes due to the impact of BREXIT in the UK, newly established processes in Asia-Pac, and new HTA assessment and evidence requirements driven by the pricing and budget impacts anticipated related to new classes of gene/cell therapies which target larger therapeutic areas.
Recently released new Technical Support Documents from NICE provide guidance on navigating increasingly common challenges with flexible survival modelling methods for immune-oncologic therapies and indirect treatment comparisons for disconnected networks including single arm studies. Utilisation of real-world data within the parameters of health technology assessments and the development of economic evidence in particular is a key impact within 2021.
We continue to bring expertise to our collaborations with the flexibility and agility that the shifting global environment requires in 2021.
In this section
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Digital Disruption
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Clinical trial data anonymisation and data sharing
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Clinical Trial Tokenisation
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Closing the evidence gap: The value of digital health technologies in supporting drug reimbursement decisions
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Digital disruption in biopharma
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Disruptive Innovation
- Remote Patient Monitoring
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Personalising Digital Health
- Real World Data
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The triad of trust: Navigating real-world healthcare data integration
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Patient Centricity
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Agile Clinical Monitoring
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Capturing the voice of the patient in clinical trials
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Charting the Managed Access Program Landscape
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Developing Nurse-Centric Medical Communications
- Diversity and inclusion in clinical trials
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Exploring the patient perspective from different angles
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Patient safety and pharmacovigilance
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A guide to safety data migrations
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Taking safety reporting to the next level with automation
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Outsourced Pharmacovigilance Affiliate Solution
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The evolution of the Pharmacovigilance System Master File: Benefits, challenges, and opportunities
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Sponsor and CRO pharmacovigilance and safety alliances
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Understanding the Periodic Benefit-Risk Evaluation Report
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A guide to safety data migrations
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Patient voice survey
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Patient Voice Survey - Decentralised and Hybrid Trials
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Reimagining Patient-Centricity with the Internet of Medical Things (IoMT)
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Using longitudinal qualitative research to capture the patient voice
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Agile Clinical Monitoring
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Regulatory Intelligence
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An innovative approach to rare disease clinical development
- EU Clinical Trials Regulation
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Using innovative tools and lean writing processes to accelerate regulatory document writing
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Current overview of data sharing within clinical trial transparency
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Global Agency Meetings: A collaborative approach to drug development
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Keeping the end in mind: key considerations for creating plain language summaries
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Navigating orphan drug development from early phase to marketing authorisation
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Procedural and regulatory know-how for China biotechs in the EU
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RACE for Children Act
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Early engagement and regulatory considerations for biotech
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Regulatory Intelligence Newsletter
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Requirements & strategy considerations within clinical trial transparency
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Spotlight on regulatory reforms in China
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Transfer of marketing authorisation
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An innovative approach to rare disease clinical development
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Therapeutics insights
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- Cell and Gene Therapies
- Central Nervous System
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Glycomics
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Oncology
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Respiratory
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Rare and orphan diseases
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Advanced therapies for rare diseases
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Cross-border enrollment of rare disease patients
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Crossing the finish line: Why effective participation support strategy is critical to trial efficiency and success in rare diseases
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Diversity, equity and inclusion in rare disease clinical trials
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Identify and mitigate risks to rare disease clinical programmes
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Leveraging historical data for use in rare disease trials
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Natural history studies to improve drug development in rare diseases
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Patient Centricity in Orphan Drug Development
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The key to remarkable rare disease registries
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Advanced therapies for rare diseases
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Transforming Trials
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Accelerating biotech innovation from discovery to commercialisation
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Ensuring the validity of clinical outcomes assessment (COA) data: The value of rater training
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Linguistic validation of Clinical Outcomes Assessments
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Optimising biotech funding
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Best practices to increase engagement with medical and scientific poster content
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Decentralised clinical trials
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Biopharma perspective: the promise of decentralised models and diversity in clinical trials
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Decentralised and Hybrid clinical trials
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Practical considerations in transitioning to hybrid or decentralised clinical trials
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Navigating the regulatory labyrinth of technology in decentralised clinical trials
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Biopharma perspective: the promise of decentralised models and diversity in clinical trials
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eCOA implementation
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Implications of COVID-19 on statistical design and analyses of clinical studies
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Improving pharma R&D efficiency
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Increasing Complexity and Declining ROI in Drug Development
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Innovation in Clinical Trial Methodologies
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Risk Based Quality Management
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Accelerating biotech innovation from discovery to commercialisation
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Value Based Healthcare
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US payers and PROs
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Accelerated early clinical manufacturing
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Cardiovascular Medical Devices
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CMS Part D Price Negotiations: Is your drug on the list?
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COVID-19 navigating global market access
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Ensuring scientific rigor in external control arms
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Evidence Synthesis: A solution to sparse evidence, heterogeneous studies, and disconnected networks
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Global Outcomes Benchmarking
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Health technology assessment
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Perspectives from US payers
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ICER’s impact on payer decision making
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Making Sense of the Biosimilars Market
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Medical communications in early phase product development
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Navigating the Challenges and Opportunities of Value Based Healthcare
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Payer Reliance on ICER and Perceptions on Value Based Pricing
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Payers Perspectives on Digital Therapeutics
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Precision Medicine
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RWE Generation Cross Sectional Studies and Medical Chart Review
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Survey results: How to engage healthcare decision-makers
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The affordability hurdle for gene therapies
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The Role of ICER as an HTA Organisation
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Strategies for commercialising oncology treatments for young adults
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