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

Clarivate Plc, a global leader in providing trusted information and insights to accelerate the pace of innovation, announced the release of the 2020 Centre for Medicines Research (CMR) International Pharmaceutical Clinical Factbook. The factbook reveals clinical trial volume has increased by 7% between 2014 and 2019 with Phase II trials accounting for the majority of trials initiated during the period. The report finds the number of Phase I and II trials have shown a slight decrease between 2015 and 2019, while Phase III has seen a slight increase. The overall duration for Phase II and III trials is comparable.

The Centre for Medicines Research, a wholly owned subsidiary of Clarivate, has released the report to help pharmaceutical and biotechnology companies benchmark their clinical strategy against industry standards and competitors. The annual publication provides insights on clinical study, country and site level metrics from Phase I through Phase IV. Leading pharmaceutical and biotechnology companies can assess clinical productivity and leverage industry trends and insights to make informed clinical planning decisions. 

Pharmaceutical and biotechnology companies are focused on developing life-saving therapies for relevant patient populations as quickly and safely as possible and continue to manage the ever-evolving and increasing complexity of drug development. As treatments become more targeted, so do clinical trials. The 2020 CMR International Pharmaceutical Clinical Factbook indicates, while Phase I and II clinical trials tend to be the most complex, Phase III trials have also seen an increase in complexity. Key findings include:

• Phase II has the highest proportion of amendments with 85% 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$90,000 per subject.1

• Asia Pacific and North 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.

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. 

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.