Emerging Biopharma
Flexible solutions. Responsive teams. Data-driven insights.
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Americas
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Asia & Oceania
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EMEA Thought Leadership
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
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Middle East & Africa
EMEA Thought Leadership
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more
Regions
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Americas
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Asia & Oceania
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Europe
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Middle East & Africa
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Americas
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Asia & Oceania
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Europe
Europe
- Adriatic
- Belgium
- Bulgaria
- Czech Republic
- Deutschland
- España
- France
- Greece
- Hungary
- Ireland
- Israel
- Italia
EMEA Thought Leadership
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more -
Middle East & Africa
EMEA Thought Leadership
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more
SOLUTIONS
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Research & Development
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Real World Evidence
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Commercialization
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Safety & Regulatory Compliance
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Technologies
LIFE SCIENCE SEGMENTS
HEALTHCARE SEGMENTS
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THERAPEUTIC AREAS
- Cardiovascular
- Cell and Gene Therapy
- Central Nervous System
- GI & Hepatology
- Infectious Diseases and Vaccines
- Oncology
- Pediatrics
- Rare Diseases
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Impacting People's Lives
"We strive to help improve outcomes and create a healthier, more sustainable world for people everywhere.
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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.
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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.
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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 REPORTSFEATURED INNOVATIONS
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IQVIA Connected Intelligence™
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IQVIA Healthcare-grade AI™
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IQVIA AI Assistant
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Human Data Science Cloud
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IQVIA Innovation Hub
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Decentralized Trials
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Patient Experience Solutions with Apple devices
WHO WE ARE
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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Our mission is to accelerate innovation for a healthier world. Together, we can solve customer challenges and improve patient lives.
LEARN MORELIFE AT IQVIA
Careers, culture and everything in between. Find out what’s going on right here, right now.
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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 JOBSWhite Paper
Global Approaches to Drug Development
When Ex-US clinical data can support US drug approvals
May 22, 2019
As drug discovery and development capabilities continue to expand globally, pharmaceutical companies are increasingly interested in understanding the most efficient way to bring drugs to the US market based on a global clinical development strategy. This trend is not limited to established multi-national corporations, as an increasing number of emerging iopharmaceutical companies are seeking a global presence to better address unmet medical needs and to maximize their commercial opportunity.
From a US regulatory perspective, the typical rule of thumb cited by experts is that “at least 20% of the supporting clinical data should be from patients in the US.” To accommodate this assumption, clinical trial strategy must include the US as a key and potentially rate limited country, which can have significant implications in terms of higher trial costs, longer study timelines, delays for achieving approval, and ultimately impacts the probability of success of the drug development program.
However, the conventional wisdom of the “20% rule” is in contrast to stated US Food and Drug Administration (FDA) regulations related to foreign clinical data.
For example, since 2008, 21 CFR Part 312.120 has permitted FDA acceptance of foreign clinical studies not conducted under an investigational new drug application (IND) as support for an IND or a marketing application, provided that these studies are conducted under Good Clinical Practices (GCP). Moreover, under 21 CFR 314.106, FDA may grant marketing approval based solely on high quality foreign clinical data.
The question that therefore faces pharmaceutical companies seeking regulatory approval for a drug in the US is: “what proportion of my study population needs to be from the US?” According to a review done by the Department of Health and Human Services, Office of the Inspector General, in fiscal year 2008, the majority of subjects and sites in trials supporting NDA and BLA approvals that year were located outside the United States (Office of Inspector General, 2010). This paper takes a closer look at FDA’s more recent track record with respect to approving drugs based on studies that were conducted with primarily non-US patient populations and examines the information FDA has accepted to demonstrate that foreign clinical data are applicable to the US patient population.
FDA’S TRACK RECORD OF ACCEPTING NON-US CLINICAL DATA TO SUPPORT MARKETING APPROVAL
METHODOLOGYA comprehensive list of drugs and biological products approved by FDA between 2013 and 2017 was collected from the FDA website. The analysis included only new drug and biological product approvals, and not reformulations or 505(b)(2) products. For each new approval, we reviewed the statistical review memorandum published as part of the approval documentation.
Through this review process, we developed a dataset by recording key elements of the study design including: number of pivotal trials submitted for review, total number of participants completing each pivotal trial, and the geographic location of each trial participant. Lastly, internal IQVIA experts reviewed the database and coded each approval into a relevant therapeutic area grouping. Through this analysis, of the 181 new drug approvals from 2013 – 2017, the percent of all participants in pivotal trials from the United States was calculated for 176 new drugs and biological products. Five approvals were excluded from analysis given lack of reporting on specific geographic mix of trial participants.
RESULTS AND ANALYSISFor the five-year period of 2013-2017, the 176 pivotal clinical studies that supported approval by FDA, had on average, 41% of study participants from the US. While this is significantly higher than the hypothesized 20% rule-of-thumb threshold, in each year there was significant variation from this mean – in every year from 2013 to 2017, some products were approved based on pivotal studies with 100% of participants from the US and others were approved based on studies with less than 10% of participants from the US.
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