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ClinPhone's
Bill Byrom on Technology's Role in the Evolving
Clinical Trial
As
this interview published, ClinPhone announced the
acquisition of DataLabs and its Electronic Data
Capture (EDC) technology. This enables ClinPhone to
become the first company in the biopharmaceutical
sector to offer a comprehensive suite of clinical
trial management and data capture systems. Read the press
release.
Bill
Byrom is Product Strategy Director of ClinPhone
plc.
Pharma DD:
Please supply a brief overview of ClinPhone.
Dr.
Byrom:
ClinPhone has been operating since 1993. Two doctors
working in a pharmaceutical company in
Nottingham
,
UK
, Drs. Neil Rotherham and Jonathan Engler, saw a
market need for technology to help with clinical
trials, in terms of ensuring patient safety.
Initially, they set up a company that focused on the
effective randomization and emergency code break of
patients in clinical trials. But shortly after
starting out, they realized that potential technology
applications to support clinical trials were much
vaster than just that one area—i.e., randomizing
patients into treatment. For example, if you were
randomizing patients, you could also be dispensing
medication. And if you were dispensing medication, you
could also control the supply chain of that medication
throughout the duration of the clinical trial to all
the sites and countries involved in the study.
As
a result of this recognition, ClinPhone has evolved
into a technology organization that has a number of
phone, Web-based, and software applications to
effectively help with the logistics and management of
clinical trials, as well as the clinical data
collection. At present, ClinPhone has over 600 staff
among three
US
offices (Princeton,
Chicago, and
Saratoga,
CA
) and its global headquarters, based in
Nottingham, UK.
Pharma DD:
What factors are currently driving ClinPhone’s
business?
Dr.
Byrom:
There are many different vendors in the market place
offering niche, or fragmented, solutions—that is,
only part of the full solution that a clinical trial
requires. Clinical trial sponsors must cherry-pick
among different providers of solutions. For example,
they might choose an IVR system to do one thing, they
may need an EDC provider to do something else, and
they could use a CTMS system for yet another aspect of
managing their clinical trial.
So
the real driver for ClinPhone is avoiding this
duplication of data and effort by examining how we can provide a complete end-to-end
solution for our clients, either delivering our own
technology in a seamless manner, or by integrating our
solutions with those of other leading eClinical
vendors so that when it comes to
our clients’ workflow, they are able to operate
efficiently. This is the rationale behind
our recent acquisition of DataLabs--with this,
ClinPhone is uniquely positioned as the first company
in the industry to offer such an extensive and robust
portfolio of trial management and data-capture
systems. By incorporating DataLabs' leading EDC
solution with ClinPhone's best-in-class randomization,
trial supply management, drug accountability, ePRO and
CTMS solutions, ClinPhone is able to not only provide
customers with a complete selection of leading
technology components required in today's clinical
trials, but also the advantages of a truly joined-up
suite of solutions managed and supported by ClinPhone.
Customers will now be able to choose first-class
solutions for all their needs--all under one roof.
This is a development that we're really excited about.
Of course, although we now offer both EDC and CTMS
solutions, we remain committed to the continued
development of integrations and relationships with
other leading solutions in these areas, as we
appreciate the value these bring to our customers.
Another
driver, which has been one since ClinPhone’s
inception, is providing solutions that help the drive
to get new drugs to market faster. That is
ClinPhone’s underlying goal. We are always looking
at processes and technology solutions that will enable
our clients to operate faster.
Again, by extending our suite of services and software
into the EDC area, we are able to make greater impact
on this overarching objective.
Pharma DD:
What are the major trends affecting your clients? That
is, what factors are currently impacting the clinical
trial process?
Dr.
Byrom:
As I described above, one of the major trends for
ClinPhone, and what we are seeing across the industry
as well, is an increased move toward integration.
Sponsors are using many different solutions, and all
for great reasons, because these technology solutions
are helping them do things more efficiently and keep
track of their crucial information. But still, at the
end of the day, they’re more than likely using a
multitude of systems, e.g., a clinical trial
management system, a safety system, an EDC system, an
IVR solution, drug-supply management systems. All the
data contained in these different solutions overlap.
As a result, sponsors spend time re-keying their data
into each one of them, and reconciling the data
between them--they’re performing the same activity,
and so they’re recording the same data into each
solution. It is critical for us to look at the
processes our customers are following in order to
effectively implement their clinical trials and manage
them effectively. We need to ask the questions: What
types of software solutions are sponsors using at each
step in the clinical trial process? How can those
(disparate) systems be joined up in such a way that it
streamlines that process? Are there any gaps in the
current process which could be addressed and
accelerated by new application of technology?
There
are other things taking place too. One of the things
we’re noticing is that clinical trials are becoming
much larger and far more complicated. A good example
of that is a topic that has been publicly discussed
over the past year or so at conferences, and that is
the concept of adaptive trials. An adaptive trial
involves rethinking how a clinical trial is designed
in the first place. Some of the most exciting ones are
effectively redesigning how to go about a Phase II
study in order to select the best dose to take into
Phase III, and then onto the market. Another exciting,
innovative adaptive design is the seamless Phase
II-into-Phase III study. These are enormously
promising. In these designs, patients are recruited
initially for the dose-finding phase (Phase II). From
that, the dose to take forward into Phase II is
determined, but during the decision period the study
sites are kept open, and then continue to recruit once
the Phase III component of the study begins. Such a
design confers an enormous time savings because it
avoids much of the set-up activities normally involved
in commencing a Phase III study. The trial can be
switched back on again when that decision has been
made, based on data collected from Phase II.
So,
these are things that people are looking at
enormously, because such innovative trial designs
could 1) have a big impact on achieving the correct
dose in the first place; and 2) shear months off the
development program. We see that these types of
designs really benefit from technology solutions (due
to the types of activities these designs require; for
example, dropping treatment arms, or changing the
randomization schedule). Technologies such as EDC
systems, IVR, and electronic patient diary systems all
have a big role to play in being able to effectively
deliver these types of studies. There have been some
large seminal studies recently, wherein some of the
larger pharmaceutical companies have achieved great
success with these trials. So I see this as becoming
an increasingly important area.
Pharma DD:
What will your industry (i.e., clinical technology
services and software) look like in five years?
Dr.
Byrom:
Clinical trials will undeniably be more complicated
and technology has a role to play in facilitating the
execution and management of these large, complex
studies.
There
are also new geographies involved in clinical trials,
for a number of reasons. For example, ClinPhone
currently operates in 88 countries and 71 languages.
And this list grows every year. We’re constantly
adding more countries because pharmaceutical companies
are choosing to run trials in increasing remote places
to 1) get patients who are naïve to modern therapies;
or 2) effectively recruit patients, which is becoming
increasingly difficult. Many more studies are
conducted in south-east Asia, the Asia-Pacific Rim,
South America
, and eastern European countries. So a shift in
geographic region will be one change, which in turn
has an impact on the nature and language capabilities
of the technology solutions delivered to support
clinical trials—particularly those used by sites and
patients.
We
are also seeing a trend toward more outsourcing. And
this happens to be across the board—so not just
outsourcing for technology, but also outsourcing
monitoring data management and other activities.
Clearly, that’s a positive for companies such as
ClinPhone.
Certain
countries, and
India
is a notable example, have been enormously successful
in terms of their research and development
capabilities and also in terms of establishing very
high-quality facilities to perform clinical research.
For
example, some CROs offer central interpretation of
EKGs as a service. Some of that interpretation is done
in
India: An EKG is sent electronically, trained readers
(located in
India
) read and interpret them, and turn the results around
overnight. We’re seeing more and more of that type
of outsourcing activity. We are also seeing more and
more technology being developed in India--it is truly
becoming an exciting hub of pharmaceutical R&D.
Another
trend, which I addressed earlier, is the result of
fragmentation, and the multitude of vendors that are
offering parts of a complete solution. I think there
will be more consolidation. In five years, there will
probably be fewer vendors, and more than likely those
vendors that exist will offer solutions that cover
more of the suite
of technology services that a sponsor requires for a
clinical trial.
For
some time now, ClinPhone has been positioning itself
as a clinical technology organization. Within our industry, we have CROs,
which provide a broad application of services to do
all sorts of things, ranging from data management, to
monitoring, to producing reports, et cetera. In a
similar way, my feeling is that clinical technology
organizations such as ClinPhone will ultimately
provide a full portfolio of technology solutions that
sponsors will be able to apply to any clinical trial.
Another
trend worth mentioning is the FDA’s Critical Path
initiative, which identifies some of the current
bottlenecks in clinical development. One of those is
patient recruitment. Certainly, more than 80% of
clinical trials fail to recruit on time, and this
obviously has a major impact on the ability of
pharmaceutical companies to develop medications and
get them to regulators (and the market) in a timely
manner. As a consequence, we see within the industry a
much bigger push toward having strategies in place and
new ways of recruiting patients. Pharmaceutical
companies are creating their own patient recruitment
departments to crack this problem, and are employing
strategies that do not solely rely upon recruitment
being done through clinics, but also through
advertising campaigns, which has been going on in the
US
for some years. Now in
Europe, this tactic is becoming more commonplace. As a
result, ClinPhone has seen an uptake in the use of our
technologies to support these advertising campaigns.
One such example is using the phone and the Web to
qualify and screen candidates who respond through the
advertisements. That’s yet another trend on the
patient-recruitment side of things.
Pharma DD:
How is ClinPhone evolving to meet these future trends?
Dr.
Byrom:
One thing we constantly have to do is evaluate what
the market needs, and look for gaps in the technology
jigsaw puzzle that we could potentially fill. As a
good example, in June this year, ClinPhone launched a
new Web-based solution for drug accountability. We saw
a gap in the market in terms of what our current
solutions--and what everyone else’s current
solutions--were (and were not) able to do. Current IVR
applications are well suited to manage and track the
shipment of drug from depot to site to allocation to a
patient. However, this is not where the activities
end. Sponsors and investigators must maintain
dispensing records, collect used and partially used
medication packs back from patients, perform and
record pill counts. Monitors then verify and reconcile
this information by performing site inspections, and
also ship used medication to depots or destruction
facilities. Ultimately, every medication pack assigned
to a clinical trial must be accounted for and
ultimately associated with a destruction
certificate—documentation has to be in place to
prove the custody of every single unit of medication
throughout the study. This is a painful and
labor-intensive process for sponsors and the effective
integration of paper medication records at sites,
depots, and destruction facilities very problematic.
As described above, current IVR/IWR technology
solutions have only tracked and managed a small
component of the complete drug accountability process.
Our new solution builds from this to effectively
manage the continuum of the complete
process. This includes providing the capability for
investigators to maintain electronic dispensing logs,
enabling monitors to perform reconciliation activities
electronically either online or offline, and providing
the capability to manage the returns and destruction
process centrally so that there are no disparate
sources of data to integrate. The ultimate result is a
fully audit-trailed report that clearly demonstrates
the full chain of custody of every medication unit.
As
we have for drug accountability, as ClinPhone evolves,
we are constantly evaluating how to extend our
solutions to cover the entire clinical-trial spectrum.
We are continually looking for the gaps. What are the
technology solutions of tomorrow, which will be needed
to plug those gaps? In this way, ClinPhone is
constantly striving to give its customers a complete,
end-to-end solution.
Pharma DD:
What are the most important distinguishing factors
between ClinPhone and its competitors?
Dr.
Byrom:
If I had to choose one, it would be ClinPhone’s
flexibility. We have many technologies and suites of
solutions. But actually, every clinical trial is
different. The most important thing is being able to
adapt our technology to effectively meet the needs of
a particular trial, as opposed to fitting the study to
the available technology. This is one thing that I
believe our customers recognize ClinPhone for: Our
flexibility--we will customize a technology
application for a clinical trial rather than vice
versa.
For
more information about ClinPhone, please visit www.clinphone.com.
URL:
http://www.pharmadd.com/exclusivecontent/ClinPhone.asp
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