|
|
|
|
|
|
|
Welcome back to our newsletter
series
Dear All,
After a short break from
publishing our inaugural newsletter, we would
like to welcome you back to our new Clinical
Connection. Through this newsletter, Allphase will
share pertinent and new information gleaned from our
experiences in running multiple trials in a variety of
therapeutic areas. We will update you on upcoming
meetings, conferences and presentations that we will
be attending, and inform you of any new service
offerings and features at our CRO.
Happy Reading,
Angelo Panzica
Chief Operating
Officer
Allphase Clinical
Research Inc.
| |
 Allphase in top growth
ranking Allphase Clinical Research Inc
is awarded 46th place in the 21st annual PROFIT100
Fastest-Growing Companies by PROFIT
Magazine.
Ottawa, ON: June 2nd,
2009 - Allphase Clinical Research Inc.
announced today that it has ranked 46th in the 21st
annual PROFIT 100 ranking of Canada's Fastest-Growing
Companies by PROFIT Magazine. Ranking Canada's
Fastest-Growing Companies by five-year revenue growth,
the PROFIT 100 profiles the country's most successful
growth companies.
In the 2003-2008 period
covered by this year's ranking, Allphase Clinical
Research Inc. realized annual five year revenue growth
of 1,626%. This period was also marked by the company's
international expansion into the United
States.
|
 Biomarkers
and adaptive clinical development
Many clinical trial
designs focus on improving disease status from baseline,
and this is the primary measure of efficacious
therapeutic response. In addition, current disease
classification/staging and risk stratification methods,
while prognostically helpful, may still fail to
adequately predict response to treatment.
Increased knowledge of disease biology has generated
promising biomarker candidates across a wide range of
therapeutic indications that will allow for more
accurate diagnosis, prognosis assessment, and
therapeutic targeting. In response to these
developments, clinical development programs have
focussed on maximizing these benefits through well
designed trials that capitalize on the utility of
prognostic and predictive biomarkers.
One path to realizing this goal is
through adaptive clinical trial design. The most
common adaptive design methods include: adaptive
randomization, group sequential designs, sample size
re-estimations, adaptive dose finding and dose removals,
adaptive treatment-switching designs, and
biomarker-adaptive designs. Adaptive
biomarker designs involve biomarker qualification,
optimal screening designs, and model selection and
validation. Prognostic biomarkers can be
used to separate patients with good- and poor-prognosis
at the time of diagnosis; whereas predictive biomarkers
can be used to identify specific patient cohorts with a
higher likelihood of treatment response. Thus, a
biomarker-adaptive design can be used to (i) select
right patient population (e.g., enrichment process for
selection of a better target patient population), (ii)
identify the course of the disease, (iii) early
detection of the disease, and (iv) help to maximize the
treatment response, thus assisting in the development
of personalized medicine regimes.
Prior to the implementation of an
adaptive trial, the following logistical issues must be
considered:
- Will the design delay patient recruitment and
prolong duration of the study and does this diminish
the advantage of the study?
- Will un-blinding of data cause potential bias in
treatment assessment/analysis?
- How will protocol deviations affect the validity
of the data?
The clinical development of a new drug
product is long and costly. For life-threatening
diseases, rare diseases, and conditions in which
treatment options are limited, options to accelerate
this process are desired. This, in combination
with the movement toward personalized medicine based on
prognostic and predictive biomarkers, the use of
adaptive clinical trial designs is called
for. Allphase Clinical Research continues to
provide insight into the advantages and disadvantages of
adaptive clinical trial designs and their
appropriateness to specific therapeutic indications in
order to assist our partners in the design of rigorous,
marker-based clinical
trials. |
Allphase Clinical
Research is a full-service, quality focused CRO
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®.
| |
|
| |
| |
