CLINICAL TRIALS
activities of daily living. These include attention, submissions; the number of CDR speaking
vigilance, information processing, short- and long- engagements across the globe; and, most importantly, Box 1: CDR fast facts
term memory, executive function, motor function the unique aspects of the company’s proprietary
• CDR is highly experienced, having conducted
and postural stability. database (which puts new study compounds into
more research projects using the CDR System
The key cognitive domains are frequently true clinically relevant terms) we feel quite strongly
than have been conducted with any other
assessed by the following CDR composite scores: that CDR is far ahead of its competitors. Our focus
available computerised battery – over 1,000
Power of Attention (acute attention); Continuity of is on continuously improving our systems and since the company’s foundation in 1986.
Attention (long-term attention); Quality of Episodic delivery of a quality product.
• Specifically in the area of cognitive enhancers
Secondary Memory (long-term memory); Quality for Alzheimer’s disease or related conditions,
of Working Memory (short-term memory); and
Q.
CDR has completed over 188 programmes,
Can you explain how CDR expanded into
Speed of Memory.
resulting in well over 100 publications. The
the US?
company has also completed 72 trials for
Q.
compounds in schizophrenia and 65 in the
What types of companies does CDR
CDR was founded in 1986 in a UK office just west
area of sleep disorders.
partner with? of London and has been conducting trials across
• The CDR System has proven sensitivity to
the globe since then. In 2006 the decision was changes in cognition to millisecond accuracy.
We have worked with the top 17 global made to set up a permanent office in the US to
The system was designed to assess both
pharmaceutical companies and we maintain handle all research activities for the company’s
improvements and impairments in cognitive
preferred vendor agreements with many of them – North and South American trials, in addition to
function in the clinical trial setting, and the
but the relationships need to be kept confidential. some Asian studies. The US office began with a
company has established itself as a world
leader in both cases. The high sensitivity can
There are also a number of small to mid-sized single staff member in 2006 but will have 17 full-
reduce the number of subjects/patients
pharma and biotech companies that have set up time employees by the end of 2008.
required in trials as well as study duration –
preferred vendor relationships. And we have a non- The US workforce includes a key management
both key benefits for clients.
exclusive partnership with a handful of clinics team (office manager, operations manager, data
• CDR has a long history; the research that led
across the globe, allowing CDR to recognise manager), operations support (project associates,
to the company’s formation began in 1973,
operational efficiency for things such as training, project assistants), data support (data coordinator,
and ever since then CDR has sought to be
shipping and study oversight. data assistant), IT (IT assistant, IT programmer), QA innovative and “ahead of the curve” in its field.
manager, two full-time business development
• The company is global with offices in the UK,
Q.
directors, and myself in the role of vice-president/
How do clients use the data that CDR
the US and Australia, allowing full 24-hour
director to oversee it all. As a testament to a truly coverage every business day.
collects from trial subjects?
engaged team committed to providing a quality
• The CDR System is currently validated in 60
service to its clients, the US office has not
Clients use CDR data in various ways, often as a
languages.
encountered any employee turnover since its
safety endpoint, for example in alcohol interaction
• The company’s technology captures data that
incorporation in July 2006.
trials and to support product labelling.
are clinically relevant. CDR can interpret results
In other work, clients use CDR data as an
in a meaningful way for regulatory authorities,
indication of early efficacy, for example to assess Q. What have been the company’s recent
clinicians, sponsors and patients alike.
cognitive enhancement in healthy subject (Phase I)
highlights?
• CDR has the world’s largest database of
trials. This research is often followed up by later
normative cognitive data.
phase studies in target patient populations – or in
Over the past 18 months, CDR has conducted a
• The validity, reliability, clinical utility, sensitivity
the case of smaller companies, they will often seek
and everyday relevance of the CDR System
massive rewrite of its testing system. The
partnerships with big pharma.
have been documented in over 150 peer-
programme is currently going through final
reviewed publications. CDR data have been
In Phase II and III, CDR data are used to
validation testing and will be soon available for use
presented in leading journals including the
determine the effectiveness of products, and also
in clinical trials. This was a necessary technical New England Journal of Medicine, Journal of the
to monitor the outcome of treatment in a variety
upgrade that allowed the company to incorporate American Medical Association and The Lancet.
of indications on cognitive function. Some clients
exciting new features into the CDR system making
• The CDR System has been correlated with
use the data in their advertising, such as with
it better than ever. industry-accepted clinical measures, such as
breakfast cereal producers.
the ADAS-cog, MMSE, Activities of Daily Living,
Q. What benefits can CDR offer to
Q.
Global Impression of Change and Caregiver
Where will the company be in five years’
Indices.
companies choosing to use its system?
time?
• Stimuli are never presented to a subject/
patient more than once per trial, hence
The core CDR business is expected to remain the
This often sounds like a cliché, but CDR can be a
minimising learning effects. There are over 70
same: focusing on cognitive testing in the clinical parallel (alternate) forms of the CDR test
truly flexible partner. As a small private company,
trial setting (Phases I-IV). The market will expand so
battery.
CDR can quickly bend and flex to meet the needs
we expect to see not only a greater volume of
of its clients. The knowledge of cognitive science
• Tests are simple and effective, and backed by
work, but also larger single study programmes. We rigorous statistical measures.
held in-house is second to none and can be
expect our collaborative (academic) programme to
invaluable for any development programme.
• CDR supports a wide range of academic
expand – particularly in Australia and the US. We research programmes, advancing cognitive
Q.
see ourselves working closely with the FDA to
science and enabling CDR to collect data
Who are CDR’s competitors? develop the best set of clinical test batteries for the
invaluable to its clients.
study of dementia and related disorders. Overall, • CDR offers scientific support and protocol
Looking at the total number of trials conducted by we see CDR maintaining and consolidating its
review process: advising clients on tests, time-
CDR across the globe (1,000+ in 60 languages); the leading position in the area of cognitive testing
points, trial design, expected effect sizes and
number of ongoing trials; the vast numbers of through innovation, quality and unique business
interpretation of results.
different types of patient populations studied; the venture.
• A team of over 70 motivated and dedicated
unsurpassed number of publications (115+
research professionals ensures that CDR gives
Caroline Richards is a reporter for Scrip.
specifically in cognitive enhancement) and abstract
unsurpassed quality and service.
www.scripnews.com/supplements Scrip 100
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