[October 27, 2016] |
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QuintilesIMS Institute Report Identifies Nine Evidence-based Approaches to Transform Drug Development and Commercialization
Life sciences companies increasingly are seeking new models to connect
expanding sets of disparate, non-identified patient-level data streams
to better develop and commercialize next-generation medicines. The need
for practical, evidence-based approaches is especially acute at a time
when scientific advances, the growing need for new medicines, and
constrained budgets for healthcare and other social services are
colliding.
According to a new QuintilesIMS Institute report, connected insights
derived from big data enhance scientific and therapeutic expertise.
These insights also drive informed decisions along the entire continuum
of care-from pipeline to portfolio to population health. As health
systems accelerate the transition to value-based use and payment
approaches, mastering the collection and interpretation of data is
essential to advancing medicine and medical technologies.
"Drug costs and spending are being scrutinized more intensely worldwide.
At the same time, the challenges associated with developing new
medicines remain extraordinarily high," said Murray Aitken, senior vice
president and executive director of the QuintilesIMS Institute. "This
confluence of pressures will lead to a crisis in biomedical innovation
unless the industry applies a more strategic approach-one that links
actionable insights earlier in clinical development and
commercialization."
The report-Connecting Insights: Bringing Better Outcomes from
Pipeline to Patient Using Data and Analytics-highlights nine
evidence-based approaches:
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Improving study design by better linking indications and target
endpoints.
In every randomized controlled trial (RCT),
therapeutic agents must be tested against defined potential
indications. Often, a clinical study will succeed or fail based on the
primary outcome endpoints that are chosen. Real-world insights, shared
data and large datasets that supplement RCTs can help identify precise
and useful primary outcome endpoints. They also can enable more rapid
validation and acceptance of surrogate endpoints.
-
Improving patient targeting through better inclusion/exclusion
criteria and biomarker-based segmentation approaches.
Biomarkers
are a measurable indicator of a biological state or condition.
Historically, biomarker identification has been conducted during
pre-clinical research on a small scale. The advent of gene expression
profiling, genetic analysis and genomic profiling now enable target
and biomarker discovery to be applied beyond pre-clinical research to
clinical studies and practice.
-
Optimizing site identification and improving site efficiency.
Maximizing
the value of a clinical asset largely depends on smart program and
trial designs. Where clinical trials are located is critically
important-requiring consideration of many site-selection measures.
Applying new data types and innovative analytics can increase
patient-per-site enrollment while minimizing protocol amendments.
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Executing clinical studies more efficiently via risk-based
monitoring.
Clinical trial site monitoring accounts for an
estimated 21 percent of the total cost of clinical trials, making it
the single highest cost factor for drug development. Risk-based
monitoring (RBM) is an effective way for identifying site-related
risks before they create issues and unnecessary costs. These
approaches require large amounts of longitudinal data covering sites,
study types and indications. Using big data modelling tools, risk
patterns can be identified and mitigation strategies
developed-particularly for known failure points that follow study
start-up.
-
Improving standards of care and outcomes analysis to determine
optimal care paths.
Applying rigorous anaysis to real-world
treatment patterns, resource utilization and patient outcomes can
yield actionable insights for healthcare stakeholders. Electronic
medical records combined with registries, claims data and other
sources of evidence can complement clinical research and drive
innovative patient care solutions.
-
Lifting levels of patient adherence in medication use.
The
economic consequences of patient nonadherence are estimated to account
for 4.6 percent of global total health expenditure, representing the
majority of the world's total avoidable costs linked to suboptimal
medicine use. The movement toward outcomes-based contracting, the
shift of risk from payer to provider and the greater use of
value-based insurance design are all contributing to a greater focus
by stakeholders on this issue. Advances in technology and data
analytics are enabling new approaches that: recognize the diversity of
underlying drivers of patient nonadherence; apply predictive analytics
to stratify patients based on risk and consequences of nonadherence;
using a broader range of interventions including low-cost
smartphone-based apps; and integrate adherence measures into patient
records.
-
Reaching physicians and patients with appropriate medicines.
Linking
real-world data with analytics is generating new insights to better
understand patient habits, health journeys and engagement with
healthcare professionals, as well as to measure patient outcomes. This
also helps identify physicians likely to have patients who can benefit
from new medicines so that manufacturers can efficiently provide
relevant educational information to those prescribers.
-
Evaluating medical value and real-world evidence in decision-making.
A
proliferation of frameworks and assessment approaches now exist in
response to increased calls for new medicines to demonstrate "evidence
of value" to patients and health systems. These new approaches
increasingly draw on information and analysis that go beyond
traditional RCT data and include electronic medical records, claims
data, mortality data, consumer data, registries, data collected in
observational studies and chart reviews.
-
Applying post-market data to drive portfolio planning and predict
market dynamics.
The biopharmaceutical industry increasingly
is focused on niche segments such as rare diseases and patient
sub-populations. The relative scarcity of precise data within these
sectors presents challenges when making commercial decisions during
asset development and deployment. Companies are addressing these
challenges by leveraging real-world insights to measure patient
populations in complex settings and using advanced analytics to bridge
gaps in data availability.
The report cites four critical hurdles to realizing the full power of
connected insights: maintaining data privacy; incorporating dynamic
approaches to the application of data; ensuring transparency when
multiple data sources and analytics are applied; and collaborating with
diverse constituents who may have conflicting interests.
Said Aitken: "Properly harnessed, data analytics can drive remarkable
progress in allocating healthcare resources, developing and
commercializing new medicines, as well as improving population outcomes."
The full version of the report, including a detailed description of the
methodology, is available at www.quintilesims.com.
The study was produced independently as a public service, without
industry or government funding.
About the QuintilesIMS Institute
The QuintilesIMS Institute provides key policy setters and decision
makers in the global health sector with unique and transformational
insights into healthcare dynamics derived from granular analysis of
information. It is a research-driven entity with a worldwide reach that
collaborates with external healthcare experts from across academia and
the public and private sectors to objectively apply the company's
proprietary global information and analytical assets. More information
about the QuintilesIMS Institute can be found at: http://www.imshealth.com/en/thought-leadership/quintilesims-institute.
About QuintilesIMS
QuintilesIMS (NYSE:Q) is a leading integrated information and
technology-enabled healthcare service provider worldwide, dedicated to
helping its clients improve their clinical, scientific and commercial
results. Formed through the merger of Quintiles and IMS Health,
QuintilesIMS's approximately 50,000 employees conduct operations in more
than 100 countries. Companies seeking to improve real-world patient
outcomes and enhanced clinical trial outsourcing through treatment
innovations, care provision and access can leverage QuintilesIMS's broad
range of healthcare information, technology and service solutions to
drive new insights and approaches. QuintilesIMS provides solutions that
span clinical to commercial bringing clients a unique opportunity to
realize the full potential of innovations and advance healthcare
outcomes.
As a global leader in protecting individual patient privacy,
QuintilesIMS uses healthcare data to deliver critical, real-world
disease and treatment insights. Through a wide variety of
privacy-enhancing technologies and safeguards, QuintilesIMS protects
individual privacy while managing information to drive healthcare
forward. These insights and execution capabilities help biotech, medical
device, and pharmaceutical companies, medical researchers, government
agencies, payers and other healthcare stakeholders in the development
and approval of new therapies, identify unmet treatment needs and
understand the safety, effectiveness and value of pharmaceutical
products in improving overall health outcomes. To learn more, visit www.quintilesims.com/.
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