SOLUTIONS
-
Research & Development
-
Real World Evidence
-
Commercialization
-
Safety & Regulatory Compliance
-
Technologies
LIFE SCIENCE SEGMENTS
HEALTHCARE SEGMENTS
- Information Partner Services
- Financial Institutions
- Global Health
- Government
- Patient Associations
- Payers
- Providers
THERAPEUTIC AREAS
- Cardiovascular
- Cell and Gene Therapy
- Central Nervous System
- GI & Hepatology
- Infectious Diseases & Vaccines
- Oncology & Hematology
- Pediatrics
- Rare Diseases
- View All
Obesity
"Advancing obesity and obesity-related trials with patients at the center of development.
LEARN MORE
Harness the power to transform clinical development
Reimagine clinical development by intelligently connecting data, technology, and analytics to optimize your trials. The result? Faster decision making and reduced risk so you can deliver life-changing therapies faster.
Research & Development OverviewResearch & Development Quick Links
Real World Evidence. Real Confidence. Real Results.
Generate and disseminate evidence that answers crucial clinical, regulatory and commercial questions, enabling you to drive smarter decisions and meet your stakeholder needs with confidence.
REAL WORLD EVIDENCE OVERVIEWReal World Evidence Quick Links
See markets more clearly. Opportunities more often.
Elevate commercial models with precision and speed using AI-driven analytics and technology that illuminate hidden insights in data.
COMMERCIALIZATION OVERVIEWCommercialization Quick Links
Service driven. Tech-enabled. Integrated compliance.
Orchestrate your success across the complete compliance lifecycle with best-in-class services and solutions for safety, regulatory, quality and medical information.
COMPLIANCE OVERVIEWSafety & Regulatory Compliance Quick Links
Intelligence that transforms life sciences end-to-end.
When your destination is a healthier world, making intelligent connections between data, technology, and services is your roadmap.
TECHNOLOGIES OVERVIEWTechnology Quick Links
CLINICAL PRODUCTS
COMMERCIAL PRODUCTS
COMPLIANCE, SAFETY, REG PRODUCTS
REAL WORLD PRODUCTS
- Real World & Healthcare Data
- Health Data Apps & AI
- Analytics Research Accelerator
- Expert Ecosystem
- AI Patient & HCP Profiling- Commercial
- AI Patient & Provider Profiling- Med Affairs
- AI Patient & HCP Profiling- Healthcare
- Natural Language Processing
- Market Access Insights
- Direct-to-Patient Research
BLOGS, WHITE PAPERS & CASE STUDIES
Explore our library of insights, thought leadership, and the latest topics & trends in healthcare.
DISCOVER INSIGHTSTHE IQVIA INSTITUTE
An in-depth exploration of the global healthcare ecosystem with timely research, insightful analysis, and scientific expertise.
SEE LATEST REPORTS
FEATURED INNOVATIONS
-
IQVIA Connected Intelligence™
-
IQVIA Healthcare-grade AI®
-
IQVIA AI Assistant
-
Human Data Science Cloud
-
IQVIA Innovation Hub
-
Decentralized Trials
-
Patient Experience Solutions
WHO WE ARE
- Our Story
- Our Impact
- Commitment to Global Health
- Code of Conduct
- Sustainability
- Privacy
- Executive Team
NEWS & RESOURCES
Unlock your potential to drive healthcare forward
By making intelligent connections between your needs, our capabilities, and the healthcare ecosystem, we can help you be more agile, accelerate results, and improve patient outcomes.
LEARN MORE
IQVIA AI is Healthcare-grade AI
Building on a rich history of developing AI for healthcare, IQVIA AI connects the right data, technology, and expertise to address the unique needs of healthcare. It's what we call Healthcare-grade AI.
LEARN MORE
Meet the IQVIA AI Assistant
Your new expert analyst is here. Be at the forefront of data-driven decision-making with a new generative AI tool that enables you to interact with our products and solutions like never before. Get results you can trust, faster.
LEARN MORE
Your healthcare data deserves more than just a cloud.
The IQVIA Human Data Science Cloud is our unique capability designed to enable healthcare-grade analytics, tools, and data management solutions to deliver fit-for-purpose global data at scale.
LEARN MORE
Innovations make an impact when bold ideas meet powerful partnerships
The IQVIA Innovation Hub connects start-ups with the extensive IQVIA network of assets, resources, clients, and partners. Together, we can help lead the future of healthcare with the extensive IQVIA network of assets, resources, clients, and partners.
LEARN MORE
Proven, faster DCT solutions
IQVIA Decentralized Trials deliver purpose-built clinical services and technologies that engage the right patients wherever they are. Our hybrid and fully virtual solutions have been used more than any others.
LEARN MORE
IQVIA Patient Experience Solutions
Empowering patients to personalize their healthcare and connecting them to caregivers has the potential to change the care delivery paradigm.
LEARN MOREIQVIA Careers
Featured Careers
Stay Connected
WE'RE HIRING
"At IQVIA your potential has no limits. We thrive on bold ideas and fearless innovation. Join us in reimagining what’s possible.
VIEW ROLESInstitute Report
Evolving Oncology Endpoints
A new horizon for health outcomes
Jul 08, 2021
About the Report
This report examines trends in new and evolving oncology endpoints being studied in clinical trials. It also looks closely at how these evolving endpoints could potentially be used to evaluate clinical benefit, support regulatory approval, and inform payer reimbursement decisions effectively and more efficiently. Case examples are included to paint a picture of how payers in the EU and U.S. are beginning to evaluate these evolving clinical trial endpoints as part of reimbursement decisions.
Report Summary
Advances in cancer treatments have led to longer survival for patients across a range of tumor types. Traditionally, clinical trials for medicines measure long-term survival and do not measure evolving endpoints, but this presents a challenge because of the need to get the right product to patients at the right time. This has prompted the exploration of new, evolving endpoints that consider the difficulty in capturing long-term survival, while still providing a means to measure clinical value for adjuvant and neoadjuvant therapies and allowing for the comparison of trials across multiple dimensions. Although these evolving endpoints have already been used for regulatory approvals, there are still conflicting opinions among payers on when they may inform reimbursement decisions. Assessing the landscape of emerging endpoints provides all stakeholders with visibility to the issues that require further consideration and investigation as they move closer to broad use for regulatory approvals and reimbursement – and ensure that timely access to novel therapies can be provided to patients with cancer who need them.
Key Findings
Exhibit 2: Advantages and Disadvantages of Endpoints
- PFS is frequently used as a surrogate marker for regular and accelerated/conditional approval, which requires limited patient numbers and shorter follow-up periods relative to OS.
- ORR can also be used as a surrogate marker, allowing for clinical benefits to be measured in a shorter period of time compared to survival.
- Additionally, the strength of association between ORR or CR and either PFS or OS vary widely between and within studies, making it difficult to discern a consistent pattern.
Exhibit 3: Summary of Total Primary Endpoints
- Evolving endpoints make up 13% of primary endpoints used in Phase II or III trials.
- The evolving endpoints most commonly used in clinical trials are pathologic complete response followed by relapse rate and disease-free survival.
Exhibit 6: Occurrence of Endpoints in Clinical Trials Annually (2016-2020)
- The use of disease control rate has been increasing over the last five years within clinical trials.
- Both minimal residual disease and relapse rate have the greatest increase in use over the last year.
Exhibit 9: Summary of Qualitative Discussions for Evolving Endpoints in Priority Indications
- Based on qualitative discussions, emerging endpoints were identified as more relevant for adjuvant or neoadjuvant patients – including DFS, MRD, pCR, RR, and time to response.
- Across the board, emerging endpoints are relevant for newer products with improved efficacy and long-term survival, but some endpoints (e.g., time to response) may not be applicable for HTA evaluations.
- Emerging endpoints were less relevant for advanced or metastatic tumors, but disease control rates could have relevance to measure progression of metastatic disease not treated with a curative intent.