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Designing Delphi panels: A useful, non-standardised tool for patient-centric research
ICON’s PCO experts outline how to successfully design different types of Delphi panels for expert consensus, patient-centric COA and ClinRO development.
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How COAs and DHTs offer deep insights into patient experiences and treatment effects
A conversation with Sonia Bothorel, Managing Director, Mapi Research Trust and Outcome Measures Solutions.
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Why using COAs and DHTs together is the future of clinical research
Though both COAs and DHTs are tools used to evaluate a treatment’s impact, they often exist in separate spheres, rarely integrated. We argue that combining these two approaches in the same study can help researchers gather better data and improve the likelihood of regulatory approval.
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Enhancing diversity in clinical trials
To fully assess the efficacy and safety of a therapeutic indication, clinical trials must evaluate populations that are representative of the treatment population, as different people may experience the same disease differently.
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The rise of precision outcome measures
Precision outcome measures are the means by which to evaluate a meaningful change on the exact outcome of interest, regardless of tool or instrument.
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Digital endpoints widely adopted in pharmaceutical and biotech-sponsored clinical trials
Over 130 pharma and biotech organizations have relied on AI-powered digital biomarkers and sensor-derived clinical outcome assessments (COAs) to capture patient-centered endpoints.
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SDoH data analysis for proactive outcome improvement: A multilayered approach
Social determinants of health affect patients in widely variable ways, and proper, multi-layered analysis is required to gain actionable insight into patient healthcare consumption and behaviour to optimise brand strategy and deliver better solutions and services to patients.
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Navigating the complexities of healthcare data types
Navigating the landscape of healthcare data has become increasingly challenging amidst a multitude of data types including open and closed claims sets. Choosing the appropriate foundational dataset will empower data-driven solutions to your business questions.
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SDoH data for efficient, patient-centred clinical trials
The social determinants of health (SDoH) are a key component of understanding and delivering better outcomes for patients.
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How pharma can use social determinant of health to address health equity
The majority of our disease risk is social and environmental, not genetic, meaning the social determinants of health are a key piece of the puzzle. Effectively leveraging SDoH data can help close the gap in health equity and reveal new insights to guide pharma brand growth.
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The impact of real world evidence on drug marketing approval and reimbursement
Increasing use of real world data and real world evidence for market regulatory decisions can lead to a more holistic understanding of safety and potency factors for healthcare practices.
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Managed access programs as an alternative to long-term follow up studies
Managed Access Programs (MAPs), are one solution for early access to investigational products that are gaining traction.
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Encouraging patient participation in real world studies
Real world data offers an alternative approach to observational research, particularly to inform decisions on patient needs and preferences.
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Improving access and reimbursement for specialty therapies
Clinical development can better satisfy the evidence needs of payers, and not incorporating the needs of payers early into trial designs risks the need to spend more money later on.
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Five common literature reviews for RWE generation
In the evidence-based era of medicine and decision-making, literature reviews offer a faster and more cost-efficient method to gather intelligence.
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Revised Common Rule for the Protection of Human Subjects
On 19 January 2017, revisions to the Common Rule were published in the Federal Register, which will take effect in January 2018.
In this section
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Digital Disruption
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Clinical strategies to optimise SaMD for treating mental health
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Digital Disruption: Surveying the industry's evolving landscape
- AI and clinical trials
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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
- mHealth wearables
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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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Decoding AI in software as a medical device (SaMD)
- Software as a medical device (SaMD)
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Clinical strategies to optimise SaMD for treating mental health
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Patient Centricity
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Accelerating clinical development through DHTs
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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
- Representation 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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Prioritising patient-centred research for regulatory approval
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Accelerating clinical development through DHTs
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Regulatory Intelligence
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Accelerating access
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Meeting requirements for Joint Clinical Assessments
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Navigating the regulatory landscape in the US and Japan:
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Preparing for ICH GCP E6(R3) implementation
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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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Demystifying EU CTR, MDR and IVDR
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Transfer of marketing authorisation
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Exploring FDA guidance for modern Data Monitoring Committees
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Streamlining dossier preparation
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Accelerating access
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Therapeutics insights
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Endocrine and Metabolic Disorders
- Cardiovascular
- Cell and Gene Therapies
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Central Nervous System
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A mind for digital therapeutics
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Challenges and opportunities in traumatic brain injury clinical trials
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Challenges and opportunities in Parkinson’s Disease clinical trials
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Early, precise and efficient; the methods and technologies advancing Alzheimer’s and Parkinson’s R&D
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Key Considerations in Chronic Pain Clinical Trials
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ICON survey report: CNS therapeutic development
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A mind for digital therapeutics
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Glycomics
- Infectious Diseases
- NASH
- Obesity
- Oncology
- Paediatrics
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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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Therapeutic spotlight: Precision medicine considerations in rare diseases
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Advanced therapies for rare diseases
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Endocrine and Metabolic Disorders
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Transforming Trials
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Accelerating biotech innovation from discovery to commercialisation
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Demystifying the Systematic Literature Reviews
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Ensuring the validity of clinical outcomes assessment (COA) data: The value of rater training
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From bottlenecks to breakthroughs
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Linguistic validation of Clinical Outcomes Assessments
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More than monitoring
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Optimising biotech funding
- Adaptive clinical trials
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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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Blended solutions insights
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Clinical trials in Japan: An enterprise growth and management strategy
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How investments in supply of CRAs is better than competing with the demand for CRAs
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The evolution of FSP: not just for large pharma
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Embracing a blended operating model
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Observations in outsourcing: Survey results show a blended future
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Clinical trials in Japan: An enterprise growth and management strategy
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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
- Partnership insights
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Risk Based Quality Management
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Transforming the R&D Model to Sustain Growth
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Accelerating biotech innovation from discovery to commercialisation
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Value Based Healthcare
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Strategies for commercialising oncology treatments for young adults
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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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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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Integrating openness and precision for competitive advantage
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Strategies for commercialising oncology treatments for young adults
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