Pharmaceutical clinical industry report highlights factors
impacting volume, cost and duration of Phase II trials
LONDON, Nov. 24, 2020 /PRNewswire/
-- Clarivate Plc (NYSE:CCC), a global leader in
providing trusted information and insights to accelerate the pace
of innovation, today 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.
To learn more about the 2020 Centre for Medicines Research (CMR)
International Pharmaceutical Clinical Factbook,
visit https://clarivate.com/innovation-exchange/solution/cmr-clinical-factbook/.
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
https://clarivate.com/cortellis/solutions/benchmarking-services/.
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
clarivate.com.
Media Contact
Catherine
Daniel
media.enquiries@clarivate.com
1 "2020 CMR International Pharmaceutical Clinical
Factbook" October 2020. Source: The
Centre for Medicines Research
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SOURCE Clarivate Plc