Regions
MAIN/REGIONS
regions/
Regions
  1. Americas
  2. Asia & Oceania
  3. Europe
  4. Middle East & Africa
  1. Solutions
  2. Products
  3. Insights
  4. About
  5. Careers
  6. Contact Us
MAIN/search
MAIN/Solutions
Solutions/
SOLUTIONS
  • Research & Development
  • Real World Evidence
  • Commercialization
  • Safety & Regulatory Compliance
  • Technologies
LIFE SCIENCE SEGMENTS
HEALTHCARE SEGMENTS
THERAPEUTIC AREAS

Impacting People's Lives

"We strive to help improve outcomes and create a healthier, more sustainable world for people everywhere.

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 Overview
Research & 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 OVERVIEW
Real 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 OVERVIEW
Commercialization 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 OVERVIEW
Safety & 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 OVERVIEW
Technology Quick Links
MAIN/Products
Products/
CLINICAL PRODUCTS
COMMERCIAL PRODUCTS
COMPLIANCE, SAFETY, REG PRODUCTS
REAL WORLD PRODUCTS

CASE STUDY

"Data in a Day

LEARN MORE
MAIN/Insights
Insights/
BLOGS, WHITE PAPERS & CASE STUDIES

Explore our library of insights, thought leadership, and the latest topics & trends in healthcare.

DISCOVER INSIGHTS
THE IQVIA INSTITUTE

An in-depth exploration of the global healthcare ecosystem with timely research, insightful analysis, and scientific expertise.

SEE LATEST REPORTS

INSTITUTE REPORT

"Digital Health Trends 2024 - Implications for Research and Patient Care

READ MORE

EMEA Insights

"IQVIA thought leadership with a focus on EMEA.

Learn more

WHITE PAPER

"DCTs Deliver Big ROI

LEARN MORE

WHITE PAPER

"Capturing value at scale: The $4 billion RWE imperative

LEARN MORE
MAIN/About
About/
FEATURED INNOVATIONS
  • IQVIA Connected Intelligence™
  • IQVIA Healthcare-grade AI™
  • Human Data Science Cloud
  • IQVIA Innovation Hub
  • Decentralized Trials
  • Patient Experience Solutions with Apple devices
WHO WE ARE
NEWS & RESOURCES

INVESTOR RELATIONS

"Visit our investor relations site for more information.

LEARN MORE
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

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 with Apple devices

Empowering patients to personalize their healthcare and connecting them to caregivers has the potential to change the care delivery paradigm.

LEARN MORE
MAIN/Careers
Careers/
WORKING AT IQVIA

Our mission is to accelerate innovation for a healthier world. Together, we can solve customer challenges and improve patient lives.

LEARN MORE
LIFE AT IQVIA

Careers, culture and everything in between. Find out what’s going on right here, right now.

LEARN MORE

WE’RE HIRING

"Improving human health requires brave thinkers who are willing to explore new ideas and build on successes. Unleash your potential with us.

SEARCH JOBS
MAIN/Contact Us
Contact Us/
Institute Report
Evolving Oncology Endpoints
A new horizon for health outcomes
Jul 08, 2021
To download files you must give consent to process your personal data by clicking the "Accept" button below.

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.
Contact Us