New?Centre for Medicines Research (CMR) Clinical Factbook From Clarivate Highlights Increasing Cost and Complexity of Phase II Trials

Canada NewsWire

  • Phase IIhas the highest proportion of amendments with85%of all trials having amendments. 20% of all Phase II trials have 5+ amendments. Phase II trials incur the highest cost per subject at >US$90,000per subject.1
  • Asia PacificandNorth America initiated a similar number of trials between 2014 and 2018. A number of biotechnology and emerging domestic companies particularly within China are driving growth within this region.
  • Despite the high volume of trials in the APAC region, the majority of patients are being recruited from north America.

Mukhtar Ahmed, President, Science Group, Clarivate, said: “The importance of the Phase II study cannot be overstated.  Today however, as our data clearly shows, companies are as strategically focused on Phase II studies as they are on Phase III. We see this in both the overall duration of Phase II trials, which are now almost equivalent in length, and the average cost per patient.  This data highlights the increasing use of biomarkers and more complex trial designs in Phase II, where companies are increasingly focused on accelerating the delivery of products to patients.  This is also reflected in the number of protocol amendments for Phase II trials, underscoring the increasing need to do more analytics and use real-world data to inform the design of trials. Trials must be planned in the most optimal way to accelerate therapeutic outcomes and value for patients and decrease cost of bringing new medicines to market.”

CMR International published the first Pharmaceutical Clinical Factbook in 2019, an annual report designed to equip the pharmaceutical clinical sector with a reliable quotable source of key reference metrics and an insight into current industry trends. The analysis featured within the report is derived from proprietary, anonymized data gathered from more than 25 leading pharmaceutical and biotechnology companies of all sizes and therapy areas. The data and insights apply unique depth and historical context to uncover reliable industry trends, set against the changing marketplace, enabling more strategic decision-making and informing the accelerated development of life-saving therapies.

To learn more about the 2020 Centre for Medicines Research (CMR) International Pharmaceutical Clinical Factbook, visit

CMR International is the world’s most reputable source of industry metrics and trends analysis. Experience, independence and integrity paired with dedication to providing industry leading data, insights and opinions, make CMR International the partner of choice for the world’s major pharmaceutical innovators. CMR International is distinguished by its unique ability to collect, validate and analyze industry-wide proprietary R&D performance metrics, using a proven and secure process. This capability enables CMR International to provide partners with readily accessible information designed to maximize the effectiveness and efficiency of their R&D operations. As a result, CMR International is the world’s most authoritative source of pharmaceutical R&D performance metrics, facts and trends. To learn more about CMR International visit

About Clarivate

Clarivate™ is a global leader in providing solutions to accelerate the lifecycle of innovation. Our bold mission is to help customers solve some of the world’s most complex problems by providing actionable information and insights that reduce the time from new ideas to life-changing inventions in the areas of science and intellectual property. We help customers discover, protect and commercialize their inventions using our trusted subscription and technology-based solutions coupled with deep domain expertise. For more information, please visit

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1″2020 CMR International Pharmaceutical Clinical Factbook”October 2020. Source: The Centre for Medicines Research

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