Original Article

Collaboration in research protocol

design: A case study exploring
knowledge creation for the
pharmaceutical industry and
prescribing physicians
Received (in revised form): 28th June 2009

Deborah Richards
is currently employed by Gilead Sciences in the research and development department. She has over 10 years experience within
the pharmaceutical industry in clinical research and medical information roles. This research was conducted as part of a Masters
degree, which was completed before joining Gilead Sciences. The views expressed in this publication are not necessarily those of
Deborahs existing employers.

Brad Dalton
is Managing Director of medScript, a medical communication agency that supplies the Australian healthcare industry with a
range of communication and advisory board management services. He acts as a consultant to several private and not-for-profit
organisations. Brad is also a lecturer in the School of Human Life Sciences at the University of Tasmania. He is responsible
for undergraduate teaching in the areas of anatomy, physiology, pathophysiology and pharmacology to students in nursing,
biomedical science, health science and human movement studies.

Correspondence:
Deborah Richards
Gilead Sciences Pty Limited,
Level 1, 128 Jolimont Road,
East Melbourne, VIC 3002,
Australia
E-mail: Deborah.Richards@
gilead.com

ABSTRACT The pharmaceutical industry is under increasing pressure to bring

innovative products to market in a timely manner. Without access to information
from people outside the industry, this task is more difficult. Because physicians may
have a greater understanding of specific product benefits in a clinical setting,
knowledge creation within the pharmaceutical industry can be facilitated through
active physician participation in clinical trial design, thereby delivering more effective
use of medicines. Ultimately, knowledge creation efforts may enhance the use of
evidence-based decision making and improve professional practice, which in turn
will promote innovation in service and product development. The study aims to
examine the potential for knowledge creation through collaboration between
physicians and industry representatives. Eight physicians specialising in a specific
disease agreed to meet with three industry representatives who organise clinical
trials. The primary endpoint for this study was to design a phase IV clinical trial with
collaborating physicians that specifically addressed a medical need within a highly
specialised area of medicine. After meeting with industry representatives, the
physicians concluded that company-sponsored studies were not appropriate, and
any potential research should be conducted on a small scale (pilot and exploratory)
within a clinical setting. The collaboration formed in this study failed to produce the
intended result of a phase IV research protocol. Physicians were, however, able to
steer the industry representatives towards research sponsorship that would in
their opinion best serve the interests of improved patient outcomes. These findings

2009 Palgrave Macmillan 1745-7904

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www.palgrave-journals.com/jmm/

Richards and Dalton

support the importance of knowledge creation through collaboration between

physicians and pharmaceutical companies.
Journal of Medical Marketing (2009) 9, 213220. doi:10.1057/jmm.2009.20;
published online 24 July 2009
Keywords: Knowledge creation; pharmaceutical industry; physician; collaboration

INTRODUCTION
Phase I/IIIa research protocols are
fundamental for securing regulatory
approval and reimbursement of new
drugs. Protocols for phase I/IIIa clinical
trials sponsored by pharmaceutical
companies are often developed internally,
usually by head office staff. Regulatory
agencies and physicians may comment on
aspects of these protocols to ensure that
they will address key efficacy and safety
issues and are in line with current
practice.1 However, local physician
involvement is often limited to patient
recruitment. In contrast, phase IIIb/IV
research protocols tend to address issues
that are not considered critical for drug
registration, including additional health
outcomes information and/or pricing and
reimbursement data that might support
market access negotiations. This frequently
involves gathering information on how
safe and/or effective a drug is over time,
in a real-world setting. Ultimately, phase
IIIb/IV research protocols allow physicians
to gain better appreciation for the efficacy
of a drug in their specific practice and
with their particular patients.2
As limited public funds are available for
drug research, physicians will often design
research protocols (investigator initiated
studies (IISs)), and then approach the
appropriate pharmaceutical company for
sponsorship.1 This dynamic partnership
between academia and industry has many
benefits. Some IIS provide unique insights
into potential new applications for a drug,
whereas industry provides the tools with
which to convert these findings to
practical application. A recent industry
benchmarking study conducted in

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Australia showed that in 2008,

pharmaceutical companies spent
AU$34 950 000 on phase IV studies and
$16 750 000 on IIS.3
However, physicians interest in IISs
and subsequent support from the
pharmaceutical industry depend on a
variety of factors. When considering
funding for phase IV trials, pharmaceutical
companies may focus on aligning the
hypothesised outcomes with product
marketing strategy and less on advancing
medical knowledge. For this reason,
physicians may elect to work independently
on their own research. This noncollaborative or ideological divide
approach to developing later phase research
protocols may reduce the amount of
research that could potentially be conducted.
Collaboration is critical to the future
success of research. Working in
collaboration may assist industry by
enabling faster decision making and
avoiding duplicate research.4
Collaborations can also create
opportunities for knowledge sharing.
Physicians and pharmaceutical companies
may come to better understand each
others needs, resulting in a more tailored
approach towards ongoing product
development. From an organisational
perspective, obtaining information from
sources outside the company that can be
used to generate new knowledge within
the organisation presents a significant
challenge.5 However, the ability to
convert physician knowledge into focused
strategies is critical to the successful uptake
and utilisation of products.6
Relatively little is published about the
potential for knowledge creation between

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Collaboration in research protocol design

physicians and the pharmaceutical

industry. Therefore, the aim of this study
was to address the following issues. First,
whether physicians and industry
representatives can collaborate to create a
clinical trial protocol of mutual benefit
and interest. Second, whether this
collaboration can create knowledge that
industry representatives can then use to
enhance the quality use of a particular
medicine.

METHODOLOGY
This study used an action research
approach, which involves a system of
enquiry that includes planning, action and
reflection.7 This involves establishing a
framework of ideas that are incorporated
into a methodology used to investigate an
area of concern or interest. This process is
cyclic and allows for feedback. This
feedback allows changes to the operating
plan during the course of the study.7 This
methodology was chosen because action
outcomes focused on improved practice
and knowledge generation can be
achieved through a research process. The
process is participative or collaborative and
allows for critical reflection and
refinement of ideas as each cycle
progresses. Action research in general can
provide an immediate solution to a
problem while also informing theory. This
can also be repeated by others to further
advance the theory.
The framework of ideas for this study
included the following. First,
pharmaceutical companies conduct phase
IV research because it can increase quality
use of a specific medicine.2 Second,
physicians engage in research that is
clinically relevant and aims to produce
meaningful patient outcomes.1 Third, as
pharmaceutical companies also desire to
develop and market medications that
improve patient outcomes, physicians and
industry have similar goals. Accordingly,
physicians and industry representatives

2009 Palgrave Macmillan 1745-7904

could work collaboratively to design a

research protocol that has meaningful
patient outcomes.8 Finally, this
collaboration may result in knowledge
creation within the pharmaceutical
company, which could be used to further
enhance quality use of a specific medicine
(desired outcome).
The operating plan for this study
involved establishing a collaborative group
to develop a phase IV research protocol to
improve the treatment of a specific
disease. Medical personnel from a midsized pharmaceutical company invited
physicians with expertise in a specific area
of medicine from different parts of
Australia to form an advisory board.
Invitations were provided on the basis of
hospital position (for example, department
head), and through searches of online
medical databases of physicians publishing
in the field. Two physicians from each
major tertiary hospital in Australia, where
the majority of operations to treat the
disease in question are performed, were
invited to participate. At least one
physician from each hospital held the
position of Director. The relevant medical
representative from the patient advocacy
body for the disease was also invited.
Nineteen physicians were invited and
eight were able to attend, ensuring each
state and the patient advocacy body were
represented.
Three industry representatives from the
pharmaceutical company, an external
facilitator and a medical writer also
attended the meeting. The industry
representatives were responsible for
developing phase IIIb/IV research
protocols and ongoing product
development to enhance quality use of the
medicine. The facilitator was hired to
ensure that discussion was open and
honest, and meeting objectives were met.
The industry representatives actively
participated in the meeting and detailed
meeting minutes were captured. The

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medical writer prepared a literature review

detailing research findings of studies on
the disease. This review was distributed to
all advisory board participants 2 weeks
before the meeting, and included copies
of all cited publications.
An agenda was created for a face-toface meeting at the beginning of the
study. The meeting objectives were to
review clinical data relating to the disease,
to identify research gaps and to propose
clinically relevant research questions. The
desired outcomes of the meeting were to
develop research question(s) for further
exploration in a company-sponsored phase
IV study, and the creation of a small
group to act as a protocol steering
committee. Workshops were held during
the meeting that encouraged participants
to:

advisory board conduct detailed in the

Medicines Australia Code of Conduct,
edition 15, were adhered to.9
Feedback through an online
questionnaire was also sought from
participants about individual perceptions
of the collaborative approach in terms of
the value placed on this type of
interaction and physicians role in the
development of research protocols. Of
particular interest was feedback on
knowledge sharing that did or did not
occur during meetings, and the value, or
lack thereof, placed on such a
collaborative approach to protocol
development. It was anticipated that this
feedback could then be used to improve
the collaborative process to further
advance knowledge creation.

RESULTS
share expectations of the advisory board
and study participation, as a basis for
review at the end of the meeting;
identify and score (relative weighting)
general characteristics of an excellent
study and study protocol;
review gaps in the knowledge base for
treatment of the disease and clinical
practice;
identify and develop proposed research
questions to address gaps in the
knowledge base;
prioritise proposed research questions,
using weightings derived in the previous
session; and
agree on subsequent steps in protocol
development, identify working party
membership and required ongoing
communications within the group.
Minutes were recorded from the first and
subsequent meetings. The minutes were
analysed to identify new knowledge
created as part of the collaborative process
that would potentially add value to the
organisation and improve the use of the
specific medicine. All requirements for

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Knowledge creation
At the beginning of the advisory board,
the physicians were asked about their
expectations and desired outcomes of the
meeting and phase IV research protocols.
Physicians expressed curiosity about
formulating a suitable research question
and a desire to generate evidence to
support and/or improve clinical practice.
They identified a need for meaningful,
clinically important outcomes and the
opportunity to improve their
understanding of the disease process. By
participating in study design, the
physicians recognised their potential to
influence the outcome of future studies by
identifying more/less appropriate treatment
regimens and study endpoints. They
indicated that they wish to influence
how patients are recruited for studies
(for example, active involvement of
advocacy groups). They reported a desire
to influence study design to ensure that
the design is ethical from a clinical
standpoint. They wanted to ensure
that realistic questions are asked in

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Table 1: Factors influencing physicians decision to participate in pharmaceutical company-sponsored research

protocols
Transparency of the clinical trial process
Receive adequate funds
Studies should be educative, as are investigator meetings and advisory boards
Direct company involvement is preferred compared to the use of third parties (for example, Contract Research
Organisations)
Clinical studies should improve the intensity of patient management
Answer interesting questions (novel, clinically important, resulting in a change in clinical practice)
Study design should consider patient burden
Studies should generate patient enthusiasm
Marketing studies should be avoided unless they answer clinically relevant questions
Comprehensive, well-written documentation that is flexible to individual concerns
Simplistic protocols with realistic primary endpoints
It is essential that trial results are published in a reputable journal
Not only the question but also its implementation should be feasible
Efficient data management
A pre-specified plan/timeline for data management, reporting and write up is essential

pharmaceutical-sponsored studies, such as

whether drug supply would continue after
a research trial concluded, particularly if
the indication of interest was not funded
under the pharmaceutical benefits scheme.
They also suggested that any phase
IIIb/IV clinical trial should acknowledge
the clinical context in which it is run,
without disadvantaging the control group.
The participating physicians identified a
number of important factors that would
influence their decision to participate in
future trials (Table 1). The physicians
listed both positive and negative factors.
Among these factors, the clinical impact
of the research question was rated as most
important, whereas adequate funding was
ranked as least important (Table 2).
After lengthy discussion, the group
could not identify gaps in the knowledge
base relating to the disease that could
form the basis of a new research protocol.
The group decided that additional
information about the disease status before
any treatment modality is considered
would help to evaluate the potential for a
suitable research question. This
information would also help to determine
whether the area of medicine in question
is a genuine problem requiring a solution.
Most physicians keep such information
hospital databases, but do not share this

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Table 2: Physicians assessment of the five most

important factors associated with phase IV research
protocols
1. Interesting question with clinical impact.
2. Takes the patient burden into consideration.
3. Feasibility of question simplicity of endpoint/
realistic endpoints.
4. Data management that avoids third party
involvement.
5. Adequate budget.

data because no central database exists.

Group members subsequently extracted
this information in their own time, from
their hospital databases, and actively shared
the data. An additional meeting was
arranged to further discuss possible
research questions and study endpoints in
light of this new shared knowledge. The
final outcome of the teleconference was
that there were no unanswered questions,
and creating a research protocol could be
a waste of research funding for the
pharmaceutical company. Comments from
participants included Mortality and
morbidity is what really matters and this
requires a long-term study, and From the
data we provided, the disease status is not
really an issue that requires active
research.
Despite these findings, participating
physicians acknowledged that some
unanswered questions may exist that could
form the basis of a research protocol,

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Richards and Dalton

although this work is exploratory in

nature and might best be conducted
within the clinical setting on a small scale.
In this case, the pharmaceutical company
could create grant funding to enable this
research to occur independently within
the clinical research setting.
Using their own knowledge of the
disease and current treatment options, the
physicians outlined five important ideas
for small-scale projects investigating
further treatment options. These ideas
focused on both early and late phases of
the disease process, key endpoints to
evaluate and areas of current uncertainty.

DISCUSSION
The aim of this research was to explore
the potential for physicians and industry
representatives to collaborate and create
clinical trial protocols of mutual benefit
and interest. Also of interest was whether
this collaboration could create knowledge
that the pharmaceutical company could
then use to increase quality use of the
medicine in question. Discussion and
information sharing helped the physicians
to formulate five ideas for future smallscale research.
The physicians agreed to share their
own knowledge with industry
representatives to achieve a research
protocol that was clinically relevant. The
physicians agreed to collaborate because
they believed that they can positively
influence the relevance of future research
and ensure that the outcomes foster
improved patient care. Furthermore, the
physicians believed that they introduced
an element of realism into study designs.
This observation suggests that physicians
believe that protocols designed without
their input may lack clinical significance,
and are perhaps more focused on the
specific objectives of the sponsoring
company. Aitken contends that physicians
are primarily motivated to participate in
research to enhance patient care and

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deliver public benefits.10 In contrast, the

main incentive for pharmaceutical
companies to participate in research is to
develop products in a timely fashion that
will increase financial return and
shareholder value.10 In this study,
physicians and industry representatives
were able to overcome these differing
motives and collaborate to develop a
research protocol that could satisfy both
parties. Bodenheimer11 asserts that despite
company sponsored trials being tainted by
the profit incentive, they do contain the
potential for balance between the
commercial interests of industry and the
scientific goals of investigators. The
scientific goals asserted by the physicians
involved in this collaboration were
associated with ensuring the potential of the
outcomes were to improve patient care.
Linking research to action is essential in
the clinical trial process.12 If physicians
can incorporate research findings into
clinical practice, then the pharmaceutical
company could benefit from appropriate
increased use of their product, thus
creating a balance in outcomes and
supporting the concept of quality use of
medicines. Not only can physicians
introduce clinical relevance into research
protocols, they can also provide valuable,
experienced-based knowledge about
patient treatment patterns.
Physicians in this study shared
information stored on internal databases to
fill a gap in existing knowledge about the
disease and current treatment patterns.
This information proved critical for
formulating new research ideas that
(a) may not have otherwise been
considered and (b) might provide clinically
relevant, patient-focussed outcomes. They
concluded that a pharmaceutical-sponsored
study was not appropriate, and any
potential research should be conducted on
a small clinical setting. This was not the
intended outcome of the meeting.
However, the pharmaceutical company

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Collaboration in research protocol design

involved could have spent approximately

$1 million/year on a project that the
physicians might not have considered
important if this knowledge was not
available or the collaboration was not
formed. To meet this alternative need, the
pharmaceutical company could support
several small, independent research
protocols by grants. This approach may
create an opportunity for ongoing
dialogue that, in turn, could form the
basis of future collaboration between the
physicians and the company. This
collaboration could then create a shared
context for future knowledge exchange.
Tacit physician knowledge, whether it
is information stored on personal databases
or information based upon personal
experience, is a potential source of
information for pharmaceutical companies
to create knowledge that otherwise does
not exist within their own organisations.
The pharmaceutical industry is under
increasing pressure to bring innovative
products to market in a timely manner.13
Without access to information from
individuals outside the industry, this task is
all the more difficult. To prosper and
continue to create innovative products,
organisations must learn from outside
information.5
The flow of information into the
pharmaceutical industry depends upon
physicians interacting with industry. The
importance of obtaining external input
from those with current knowledge and
skills should be to challenge internal
norms and assumptions.14 This type of
feedback could enable those working
internally to incorporate new information
and revise existing assumptions. In terms
of product development, this approach
could assist with creating new products or
modifying existing products to increase
appropriate product uptake. Physician
input into research design could also
facilitate improved use of medicines
because physicians may have a greater

2009 Palgrave Macmillan 1745-7904

understanding of the product benefits

(developed early through involvement in
research design). Such collaboration
throughout the product lifecycle could see
greater alignment between pharmaceutical
company and physician goals. In this
manner, the joint vision or shared context
is improved patient outcomes.
In this study, interaction between
physicians the pharmaceutical company
formed the basis for knowledge creation.
Knowledge creation is not an individually
focused process; it has a collective and
collaborative focus.15 In this study, a
group of physicians with the common
concern came together with industry
representatives who also had a similar
concern. As part of the process, new
knowledge was created through
interaction. Indeed, increased interaction
between interested groups will have the
greatest impact on knowledge creation.15
The results of this study support this view
from the perspective of physicianindustry
interactions.
Several limitations of this study are
worth discussing. First, this study involved
a small number of physicians working
in a highly specialised area of medicine.
As this area of medicine deals closely with
immediate life and death circumstances,
there may be greater emphasis and interest
around research protocols. Secondly, it
should be noted that it is often a selfselecting group of physicians that become
involved in these types of collaborative
efforts. Consequently, the physicians
selected in our study may be more open
to working with industry to develop
research protocols than physicians working
in other areas of medicine. Lastly, a lack
of publications about knowledge creation
between physicians and the pharmaceutical
industry make the results difficult to
compare and generalise. Despite these
limitations, this study highlights the
benefits that are possible when successful
collaborations are formed.

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In conclusion, this research showed that

physicians were willing to collaborate with
industry to create a research protocol.
Interaction between the physicians and
industry representatives was successful for
creating new knowledge. A key
component of knowledge creation was that
the physicians shared tacit knowledge. Both
physicians and industry representatives
could ultimately use this knowledge to
improve patient care by increasing the
quality use of a specific medicine.

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