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International Clinical Trials
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Clinical trial recruitment is a highly competitive environment, with
sponsors and CROs vying for top-performing investigative sites and, in
turn, their patients. One key component to initiate trial activities, as
well as engage and train site staff, is an investigator meeting.
Historically,
large-scale investigator and trial-related meetings were the norm,
requiring research site personnel to travel with paid accommodations and
incidentals, and with generally no compensation for time away from
their site or patients.
However, as the economic and regulatory
environment has changed, sponsors and CROs are now utilising alternative
methods to the once standard face-to-face investigator meeting format.
In order to address concerns about the high cost of such events, as well
as any perceived incentive that might result from hosting face-to-face
meetings, sponsors and their meeting organisers have begun leveraging
digital technology as a potential solution.
Regardless of the
complexity or phase of the clinical trial, site staff need to be trained
to recruit and retain the right patients, adhere to protocol procedures
and generate high-quality data, all within regulatory boundaries.
Moreover, sponsors and meeting organisers must plan beyond the need to
cut costs and identify the most effective training environment for their
trial; they must also be cognisant of language barriers, multiple time
zones, cultural differences and/or differences in medical practice. So,
is one meeting format to accomplish this really better than another?
Face-to-Face or Virtual?
There
is no doubt that face-to-face meetings are more expensive than virtual
meetings, averaging around $2,000 per attendee for travel, accommodation
and incidentals (1). These are just the hard costs, and do not factor
in lost productivity for both the sponsor and site staff, the potential
lost revenue for some study sites, and time spent away from family and
friends.
In addition, there is concern about the poor attendance
of site staff, which can be an issue for about one-in-three
investigators and two-in-three study coordinators (2). As a result, it
can be difficult to justify the increased costs to host a face-to-face
meeting, particularly if procurement departments are pressing for
reduced budgets.
Virtual meetings are economical by comparison
but, while technology is improving their accessibility, they are not
without their challenges. To accommodate schedules – and, more
importantly, people’s attention spans – they are shorter in length,
which limits the time to cover all protocol-specific information and the
scientific rationale for the trial. Although a virtual format offers
ways to engage participants through polling, video feeds, and controlled
questions and answers, it is not as easy to optimise interaction and
relationship-building as in a face-to-face meeting.
There are
clearly pros and cons to both formats (3-5). In today’s fast-paced and
competitive environment, the reality is that both approaches are needed.
The question should then be: how do we decide between conducting a
face-to-face meeting or a virtual one?
There are several factors to assess when determining the appropriate meeting strategy.
Building Relationships
If
fostering a sense of community among site and sponsor staff is
important at the stage of the clinical trial (prior to first patient,
first visit), then a face-to-face meeting may be more beneficial. The
opportunity to network and share their own personal stories is often
cited as the most important benefit of this format.
Investigators
and study coordinators from sites, and country study managers or
monitors from sponsors, can meet and build connections, which may result
in better communication during the study. This is also important if
many parts of the study – for example, monitoring – are outsourced,
meaning that direct site-to-sponsor contact may be minimal.
Although
the impact of strong relationships among site staff and sponsors on
clinical trial completion is hard to measure, many clinical operations
teams view it as one of the most significant contributors to a study's
success.
Knowledge Acquisition
Timelines are
critical to any clinical trial, but unfortunately many fail to meet
recruitment goals as originally planned. This ultimately leads to the
study being extended and increased costs. It is therefore vital that
site staff have a clear understanding from the beginning – even before
they sign the contract – of the 'why' (rationale for the trial), the
'how' (key protocol procedures and processes) and the 'when' (timing of
various components, including recruitment).
The ongoing
communication and discussion of these key trial messages and learning
objectives is something that will continue throughout the life of a
trial. However, the phase and stage of the study is a leading
consideration when deciding on a virtual versus a face-to-face meeting.
For
example, in the case of a study start-up in a complex Phase 3b trial,
failing to clearly deliver the key messages – for instance, the need for
patient adherence to a two-week titration dosage schedule – may have a
major adverse impact on the course of the study.
In this
situation, it is essential that knowledge acquisition is optimised. With
multi-faceted trial procedures involving multiple stakeholders, a
face-to-face meeting where site staff.
If it is necessary to
draw out issues that are impeding the progress of the trial, or to
develop important action items to improve the situation, then hold a
face-to-face meeting. This would also apply to breakout sessions and
best practice sharing, if these would be beneficial to achieving the
goals of the meeting. Allowing for small groups to interact, be it for
regional, cultural or language reasons, is more easily facilitated in
person. Insights from experienced study staff are best shared and
discussed face-to-face.
Where site personnel are seasoned and
have been participating in previous clinical trials by the same sponsor –
and/or the protocol, study compounds and participants are similar to
previous clinical trials – then perhaps consider a virtual meeting that
is highly focused on elements that are different. Pre-meeting
preparatory work, such as e-learning/ online training, of the familiar
material may assist in condensing meeting time by allowing site staff to
review standardised components.
Ideal Approach
While
no two clinical trials are the same and each will come with its own set
of challenges, there are simple steps that can be taken to determine
which meeting format will best engage site staff and support achieving
study goals.
Establish Benchmarks
Setting
expectations for knowledge, performance and responsiveness of study
sites will help build the foundation of the educational programme.
Understanding what is to be achieved will guide what actions need to be
taken or what behaviours site staff need to engage in.
Consider Study Status
Assess
study sites’ current realities in terms of successes and shortcomings
with recruitment, retention and data quality. Understanding site
capabilities will assist in determining what needs to be done to get
them to an optimal level.
Develop Educational Objectives
Once
expectations and capabilities are established, develop optimal tailored
and integrated communication and educational programmes, utilising the
appropriate communication platform (face-to-face versus virtual) to
achieve goals. This may also include integrating online training – for
example, e-learning modules that might cover topics like safety
reporting, protocol review and data capture, which can be completed at
the convenience of the site staff – as a form of preparation or
pre-training in advance of meetings, but also throughout the trial as
training needs arise.
Through this integrated use
of online training, site staff should have a reasonable understanding
of the trial fundamentals ahead of a meeting. This baseline knowledge
then needs to be factored into the design and execution of either a
virtual or face-to-face investigator meeting, hopefully resulting in a
tighter meeting agenda.
Multi-Channel Formats
Many
studies are global in scope, supported by site staff in various parts
of the world. The communication of day-today operational components is
most certainly conducted through emails, web portals, and
teleconferencing and/or web conferencing. But the power of face-to-face
interactions should never be underestimated, even if the direct benefits
may be hard to define.
Upfront investment may help lower costs
in the long run if recruitment and retention are optimised. Ideally,
multi-channel integrated communication and educational programmes are
recommended, and both virtual and face-to-face meeting formats are
valuable if used for the correct purpose: to engage site staff and
support with achieving trial success.
References
1. Space S, Changing investigator meeting formats, The CenterWatch Monthly: pp1-11, August 2006
2. Chong L, Bring your investigator meetings to the 21st century, 49th Annual DIA Conference, Boston, US, June 2013
3.
Lake E, Inside investigator meetings: Why this age-old industry staple
is missing the mark for many and what can be done to remedy the
situation, Applied Clinical Trials, June 2008
4. Vogelson C, Planning a meeting with results, Modern Drug Discovery 4(3): pp53-55, March 2001
5. Morgan N, Five fatal flaws with virtual meetings, Forbes, October 2012
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Marny Bruce is a Director at AXON Clinical Trial Services, and has
supported the development and implementation of global recruitment and
retention programmes for 10 years. Marny holds an MSc specialising in
Physical Activity Epidemiology and a Postgraduate Certificate in Public
Relations. She has experience with clients such as Novo Nordisk, Serono,
GlaxoSmithKline and Wyeth in numerous therapeutic areas. Since joining
AXON in 2003, Marny has been instrumental in the growth of the team,
delivering insightful and strategic advice to global clients.
Chuck Johnston is a Partner at Axon
Clinical Trial Services. He has worked for more than 15 years on global
patient recruitment and retention programmes, and has led investigator
training initiatives across a wide range of therapeutic areas for Roche,
Boehringer Ingelheim, Pfi zer, GlaxoSmithKline, Merck, Astra Zeneca and
Bristol-Myers Squibb. Prior to joining AXON in 2002, Chuck worked at
Leo Pharma Inc, engineering the development and expansion of several key
departments. He has an in-depth understanding of the barriers and
motivation required to optimise knowledge transfer and behaviour change.
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