New Tufts survey report reveals life sciences
organizations plan to use a greater range of patient data in
clinical trials but need to prepare to manage the increasing
variety and volume of data
The volume and diversity of data sources used in clinical trials
are expected to increase significantly over the next three years,
according to new research from Tufts Center for the Study of
Drug Development. In the second report from the 2017 eClinical
Landscape Study, one of the largest, most in-depth surveys of
clinical data management professionals, 97% of companies say they
will increase use of at least one clinical data source to make
faster, more accurate decisions during trials. However, 98% of
respondents currently report challenges with their clinical data
management systems, indicating that companies will need to be
better prepared to collect and analyze the growing volume of
real-world patient data available from a variety of sources.
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The volume and diversity of data sources
used in clinical trials are expected to increase significantly over
the next three years. (Photo: Business Wire)
“Clinical trial complexity is challenging scientific, operating,
and technology solution domains,” said Ken Getz, research associate
professor and director at the Tufts Center for the Study of Drug
Development. “At the same time that clinical teams are managing
traditional data from case report forms and local and central labs,
they are being forced to step out of their comfort zone to manage,
integrate, and analyze data from more diverse and less compatible
sources, including smart phone and wearable devices, real-world
evidence, and social media.”
Volume and Diversity of Clinical Data Sources Expected to
Increase
Life sciences companies use an average of four data sources in
clinical trials today. In three years, the number of data sources
utilized is projected to increase to six, with 70% of companies
planning to use a new data source that they are not leveraging
today.
The survey also showed very significant changes in the range of
clinical information organizations plan to use in the next three
years. Nearly all (93%) respondents expect to use eInformed consent
data (up 62 percentage points from today). A majority of companies
also plan to use mHealth and smart phone data (each increasing 47
percentage points) and eSource data (increasing 46 percentage
points).
Significant differences were also observed when comparing
company type and size. CROs report they plan to use more data
sources than sponsors. Similarly, those with the highest trial
volumes (greater than 15 trials per year) say they will use more
sources of clinical data within the next three years compared to
those with lower trial volumes.
Companies Manage a Limited Volume and Variety of Data
Today
While the industry expects to leverage a greater range of
patient data in clinical trials, today companies are primarily
managing electronic case report form (eCRF) data in their primary
EDC system. In three years, 93% of respondents aim to use
electronic patient reported outcomes (ePRO) and electronic clinical
outcomes assessment (eCOA) as sources, but today that data makes up
only 4% of the total data managed in EDC. Similarly, 76% plan to
use mHealth data as a source, but only 10% are currently managing
it in their primary EDC application and it represents just 0.3% of
the total data managed in EDC.
The majority of data in EDC (78%) is eCRF, which only provides
one dimension of data into a patient’s overall health. Moving
forward, to collect and analyze a higher volume and variety of
electronic data beyond just eCRF, there will be a greater need for
EDC applications to better access and centralize clinical
information.
“Clinical trials are more sophisticated and include a growing
amount of patient data from many diverse sources. So trials are
increasingly complex endeavors,” said Scott Fisher, Ph.D.,
executive director of emerging therapies at Intrexon Corporation.
“The overall volume of data we collect is rising dramatically as we
take advantage of mHealth to accumulate billions of data points per
patient. Having a modern EDC system to bring this data together
will be key to making accurate, real-time decisions and
accelerating our clinical trials.”
Challenges with Clinical Data Management Systems
When asked about the single biggest challenge with their
clinical data management systems today, most respondents cite cycle
time (30%), including time from protocol completion to first
patient, first visit (FPFV) and time from last patient, last visit
(LPLV) to database lock. The time it takes from LPLV to database
lock is approximately 36 days which, despite efforts to shorten, is
even longer than it was more than 15 years ago (36 days vs. 33
days).1
Cost was the second most prevalent challenge among respondents
(29%), followed by the number of clinical systems (18%). The amount
of companies that cite ‘number of systems’ as their single biggest
challenge rises to 28% as trial volume increases. Respondents with
high trial volumes have seven applications versus four for those
with low trial volume. As companies manage more trials, the ability
to unify applications and processes will become increasingly
important in improving trial efficiency.
Specific to EDC, loading data into the primary EDC application
is an issue for the majority (77%) of sponsors and CROs, and 66% of
those point to EDC system or integration issues as the main cause.
Data loading challenges risk becoming a larger problem as companies
utilize more data from more sources over the next three years.
“Life sciences companies want to collect more data from more
sources, but are experiencing challenges managing the data they
have now,” said Richard Young, vice president of Veeva Vault EDC.
“There is a significant opportunity for organizations to create a
complete picture of their trials as new data points are generated
or recorded so they can drive better decisions.”
The 2017 eClinical Landscape Study: Assessing Data
Management Practices, Performance, and Challenges from Tufts
Center for the Study of Drug Development, sponsored by Veeva
Systems (NYSE: VEEV), reviews the state of data management in
life sciences with an in-depth look at the insights and opinions of
clinical data management professionals at more than 250 companies,
including sponsors and CROs, with an average of 17 years of
experience in clinical data management. Download the full report
at veeva.com/EDCSurvey.
To learn more about the latest findings, register for
the webinar, New Tufts Research: EDC Trends, Insights, and
Opportunities, featuring Ken Getz, research associate professor and
director at the Tufts Center for the Study of Drug Development, and
Richard Young, vice president of Veeva Vault EDC, on Thursday,
November 16 at 11:00 a.m. ET.
Research Highlights
2017 eClinical Landscape Study:
Usage of Data Sources, Management
Applications, and Their Challenges
The 2017 eClinical Landscape Study examines the state of
clinical data management in the life sciences industry. The goal of
the research is to understand current clinical data management
practices and assess the performance and challenges of electronic
data capture (EDC) systems.
One of the largest, most in-depth clinical data management
studies to date, this research captures the insights and opinions
of 250 clinical data management professionals, including sponsors
and CROs with an average of 17 years of clinical data management
experience.
Clinical Data Source Utilization
- 97% of companies say they will increase
use of at least one clinical data source to make faster, more
accurate decisions during trials, with 70% planning to use a new
data source that they aren’t currently using.
- Companies use an average of four data
sources in clinical trials today and are projected to use an
average of six data sources in three years.
- eInformed consent data is expected to
have the biggest increase in three years, tripling from 31% usage
to 93%.
- Use of smart phone and mHealth data
will rise by 47 percentage points, and the use of eSource data will
grow from 38% to 84%, more than doubling current usage.
- CROs are set to outpace sponsors in how
frequently all data sources are used, including eSource data (97%
to 81% usage) and mHealth data (90% to 73%).
- Companies with higher clinical trial
volume are expected to use a wider variety of data sources more
frequently than those managing fewer clinical trials.
Data Sources in EDC Applications
- The most commonly reported data type in
EDC is electronic case report form (eCRF) data (100%), followed by
local lab and quality of life (QoL) data at 60% each. 10% of
companies load mobile health data into their EDC application
today.
- 93% of respondents aim to use
electronic patient reported outcomes (ePRO) and electronic clinical
outcomes assessment (eCOA) data, and 76% plan to use mHealth data
in three years.
- While companies have a variety of data
types in their EDC, respondents say the largest proportion of the
data in EDC is eCRF data (78% of total data managed). All other
data types are each estimated at 5% or less of the total volume of
data in the EDC, including ePRO data (3%), eCOA data (1%), and
mobile health data (0.3%).
Challenges with Clinical Data Management Systems
- Nearly all (98%) clinical data
management professionals report challenges with their clinical data
management systems.
- The biggest single challenge
respondents cite is cycle time (30%), including time from protocol
completion to first patient, first visit (FPFV) and time from last
patient, last visit (LPLV) to database lock. Cycle times are the
biggest challenge for CROs (32%) and companies with a high trial
volume (31%).
- 29% of respondents said their biggest
challenge is costs in clinical R&D, including sponsors (31%),
companies using industry-leading EDC applications (30%), and low
trial volume companies (41%).
- The number of systems in clinical
R&D is the single biggest challenge for 18% of respondents,
including 28% of high trial volume companies.
- The more trials a company manages the
more clinical trial applications they use (seven applications
versus four for low trial volume).
- Loading data into the primary EDC
application is a challenge for the majority (77%) of sponsors and
CROs, and 66% of those point to EDC system or integration issues as
the main cause.
About the Tufts Center for the Study of Drug
Development
The Tufts Center for the Study of Drug Development at Tufts
University provides strategic information to help drug developers,
regulators, and policy makers improve the quality and efficiency of
pharmaceutical development, review, and utilization. Tufts CSDD,
based in Boston, conducts a wide range of in-depth analyses on
pharmaceutical issues and hosts symposia, workshops, and public
forums, and publishes Tufts CSDD Impact Reports, a bi-monthly
newsletter providing analysis and insight into critical drug
development issues. For more information, visit csdd.tufts.edu.
About Veeva Systems
Veeva Systems Inc. is a leader in cloud-based software for the
global life sciences industry. Committed to innovation, product
excellence, and customer success, Veeva has more than 550
customers, ranging from the world's largest pharmaceutical
companies to emerging biotechs. Veeva is headquartered in the San
Francisco Bay Area, with offices in Europe, Asia, and Latin
America. For more information, visit veeva.com.
1 Lamberti MJ, Kush R, Kubick W, Henderson C, Hinkson B, Kamenju
P, Getz KA. An examination of eClinical technology usage and CDISC
standards adoption. Therapeutic Innovation & Regulatory
Science. 2015.
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version on businesswire.com: http://www.businesswire.com/news/home/20171107005745/en/
Veeva SystemsRoger Villareal,
925-264-8885roger.villareal@veeva.comorTufts Center for the Study
of Drug DevelopmentRachel Stanton,
617-636-2170rachel.stanton@tufts.edu
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