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 Conference season is upon
us! Dear
Colleague,
Spring is here... and for most
of us in this industry it can only mean one thing... the
conference season is here. OK, there is also warm
weather, gardening and baseball/golf/tennis or whatever
else will take you outside.
Back to the conferences
though... they are very much an integral part of our
industry to meet, greet and exchange information. We
will be attending a handful of these this spring, but
would also like to share some of our clinical
expertise with you through this newsletter. This month,
Philip Sinclair, our newly-appointed CSO shares his
knowledge on Adaptive Trial
Design.
Happy Reading,
Angelo Panzica
Chief Operating
Officer
Allphase Clinical
Research Inc.
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 Philip Sinclair, PhD
- Promoted to Chief Scientific
Officer
Ottawa, Ontario March 26,
2010 - Allphase Clinical Research, Inc.®, a
full service provider of clinical development services
to the pharmaceutical and biotechnology industry is
pleased to announce the promotion of Philip Sinclair,
PhD to the position of Chief Scientific Officer.
Dr. Sinclair contributes over 10 years
of scientific experience in drug development to Allphase
Clinical Research, Inc.® , and previously held the
position of Director, Scientific and Clinical Affairs.
His work has been published in multiple peer-reviewed
publications and he holds a number of patents in the
area of drug metabolism. Dr. Sinclair offers a
wealth of expertise from both the scientific and
clinical arenas. His responsibilities cover a wide
range of activities including clinical operations
management, strategic and scientific study design,
international regulatory insight, and study analysis.
Prior to joining to Allphase® in
2006, Dr. Sinclair held various research and management
positions in the biotech industry and has acted as a
Research Consultant for large pharmaceutical
organizations in both North America and Japan. Dr.
Sinclair has a PhD in Toxicology and an MSc in Molecular
Endocrinology.
Jeff Smith, President and CEO,
Allphase Clinical Research, Inc.® states that "Dr.
Sinclair has contributed his remarkable talent as a
strategic and scientific thinker to the coveted
reputation of Allphase. Phil has worked tirelessly to
ensure that our clients receive the best guidance and
insight this industry can offer, thereby providing
significant advantage. By selecting and promoting
the best talent in the industry, Allphase continues to
live up to its imparted reputation as the "Professional
Research
Organization". |
 Adaptive Trial
Design
The
average cost to develop a drug from the screening
process to market approval is between 800 million and
one billion USD. Approximately 75% of the overall
cost of global drug development is consumed on products
that fail. In addition, the time to market is
approximately 10-12 years, with the majority of this
time spent in the clinical development phase.
Despite a larger understanding of numerous disease
indications and mechanisms, advances in technology, and
regulatory initiatives, the number of new therapeutics
reaching the market has not increased substantially over
the past 10 years. Forty percent of potential lead
candidates that enter into clinical development fail in
the early phases. Success in phase III studies has
also decreased. Taken together, these factors have
led to increased cost of development and a lengthening
of the development process. It is therefore of
high utility to employ strategic methodologies that are
aimed at improving the success rate, shorten the
development times, and decrease R&D
spend.
In recent years, the emergence of
adaptive clinical trial design has become attractive
given its ability to make in-trial decisions based on
real-time data. The underlying concept of adaptive
trial design is the ability to make prospective
mid-study changes without affecting the validity and
integrity of the trial data. These designs make it
possible to discover and act upon initial trial
assumptions, and make alterations to maximise the
ability to successfully meet study
endpoints.
Typically, in a standard trial,
safety and efficacy data can be reviewed during
scheduled interim analyses; however, very little can be
done in response to that data. In such cases,
additional studies may be required to further
investigate key study endpoints. In the adaptive
scenario, options for responding to both safety and
efficacy data in-study are possible and could include
the following:
-
Sample size
re-estimation
-
Modification of the primary
endpoint
-
Interim removal of treatment
arm(s)
-
Switching between superiority
and non-inferiority
-
Changes in primary
analyses
There are numerous
considerations that must be taken into account when
designing adaptive trials. Statistical methods for
controlling type I error, appropriate estimates of
treatment effects, maintenance of study blinding, and
assessment of treatment effect consistency across design
modifications are all methodological issues that must be
addressed. However, despite potential statistical
complexities of adaptive trials, these designs may more
accurately reflect clinical practice realities during
the development process. These trial designs are highly
suited for Phase I and II trials; however, can also been
implemented for select Phase III confirmatory
studies.
Allphase continues to provide our
biopharmaceutical clients with strategic adaptive
clinical trial options that represent significant
opportunity to maximize clinical development efficiency
for our development
partners.
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Allphase Clinical
Research is a full-service, quality focused Clinical
Development Organization dedicated to helping clients
achieve their clinical development goals. Allphase
collaborates with clients through all stages of
development, providing
comprehensive services in:
- Regulatory
Management
- Data Management (EDC
or paper)
- Trial Planning and
Monitoring
- Project
Management
- Training
- Medical Writing
- Quality
Assurance
Allphase's experience
and knowledge of the scientific, regulatory, and
logistical elements of clinical research allow us to
provide operational support and strategic insight into
any clinical project. Diligent application of industry
best practices ensures that our clients' projects are
managed in strict compliance with industry regulations
and laws. Allphase provides full Phase I-IV services in
all major therapeutic areas, with particular strengths
in:
- Oncology
- Cardiovascular
- CNS
- Respiratory
We have strong
relationships with medical experts in these fields, and
a vast network of top researchers in our proprietary
database. In addition, Allphase employees are members of
industry associations such as DIA, ACRP, AAAAI, and
ASCO.
Allphase thrives on
challenge and is driven to succeed at every stage
in order to be your trusted outsourcing partner.
Allphase Clinical Research is dedicated to Exceeding
Your Expectations®.
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