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International Clinical Trials
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Ours is an industry which prides itself on accuracy, cuttingedge
technology, patient and drug safety, confidentiality and regulatory
compliance. All of this carries the same ultimate objective: to make
life better by improving people’s health. Meetings and events are small
components of the overall clinical trial process and are sometimes
understandably given due consideration only at the last minute. By this
time, meeting organisers can find themselves scrambling for suitable
venues, being forced into booking expensive flights, and risk falling
foul of low attendances.
Fewer and fewer pharmaceutical companies and CROs organise their
clinical meetings in-house. The overheads, time and resource-sapping
input required to plan and deliver a successful meeting means the
pharma industry is slowly beginning to treat clinical events in the
same manner as other parts of a study. The outsourcing of meetings and
events has created a need for partners with global expertise and an
understanding of clinical research, as well as the guidelines and
regulations which govern it.
With budgets as tight as ever and a constant requirement to show a
significant return on investment, pharma companies, biotechs and CROs
alike face the challenge of producing and recognising accurate cost
estimates – and then keeping within these budgets in practice.
Ostensibly, a clinical meeting represents a relatively tiny part of an
overall study budget. In reality, what amounts to one or two days on
site for a project team and other attendees can embody a significant
investment and often weeks of planning and coordination. Of course,
drawing on the example of a new start-up study, effectively
communicating the protocol to health professionals who will be taking
part is a clinical requirement. Effective outsourcing boils down to
eliminating duplication and cutting out waste. Clinical meetings are no
different.
Those at the forefront of modern clinical research have embraced the
concept of professionally-planned, streamlined and focused meetings and
aligned their corporate approach accordingly: if we have to do this,
let’s do it properly.
Clinical meetings take many different forms. The traditional
investigator meeting is the typical example which most involved in
clinical trials would recognise. However, GCP training sessions,
advisory boards, webcast and hybrid meetings, or any one of a myriad of
events can and do take place during the life of a study. Bearing in
mind the following factors will help to avoid your next meeting falling
flat – or costing the earth.
AUDIENCE
Considering your audience is key to the success of any meeting.
Substantial thought and discussion goes into targeting the patient
population of a study, the selection of sites and prospects of
enrolling subjects to provide reliable data. It should be the same for
any clinical event.
The physicians taking part in your clinical trial, their knowledge of
the protocol, inclusion criteria, understanding of the data they need
to gather and what is required of them throughout the process will
determine the outcome of the study. CROs and study sponsors go out of
their way to make sure that their sites are treated well, kept
informed, and guided through a trial by dedicated and hardworking
project teams. It can be a challenge to keep all study participants
happy, but if their needs and expectations are considered right from
the start, a positive precedent can be set.
An appreciation of participants’ time is a big factor. Feedback from
delegates shows clearly that giving invitees as much notice as possible
makes meetings much easier to attend. It can be extremely useful to
consult participants beforehand by conducting polls to discover dates
which will suit potential attendees. This helps to gain a general
consensus to guarantee maximum attendance at an event. It also means
that delegates feel like they are being included in the process from
the start and avoids calendar conflicts.
Working with a partner that has relevant information at their
fingertips on the dates of international events, congresses, local
public holidays, as well as worldwide seasonal trends can help to avoid
arranging events over inappropriate or inconvenient dates.
Clearly, liaising with delegates can be time-consuming. This needs to
be done during periods when invitees are available, considering
timezone differences. This is especially true for larger events.
Therefore, it is important to ensure your meeting planning team or
external partner has the resources to do this well. Looking after
participants properly – within global and regional rules and
regulations, and of course within budget – can really help to promote a
successful and respectful relationship.
TRAVEL & ACCOMMODATION
In the same way, liaising with meeting attendees about their travel to
and from an event promotes inclusion and can help to boost attendance.
Many delegates comment that too often they register to attend a meeting
and then hear nothing more until they receive airline tickets for a
flight that has been prescribed for them. This may not fit in with
their schedules or may involve lengthy stopovers for connecting
flights.
Working with a participant to determine a convenient and appropriate
travel schedule promotes goodwill and can help to proactively manage
budgets. This allows the earlier booking of flights and the avoidance
of costly cancellation or alteration fees. Air travel is by far the
biggest single contributor to meeting budgets and is generally the only
pass-through cost that is non-negotiable. Flight costs become more
expensive closer to a departure date.
Apart from air travel, it is also a good idea to consider cultural
differences, geography, and the expectations of participants. Certain
cultures and religions do not allow travel, for work purposes, on
certain days. The size and location of a number of nations can mean
lengthy travel, and may require extra stopovers and accommodation.
Expectations vary, with delegates from a number of countries being used
to having transport arranged for them the moment they step out of their
own door.
Providing delegates with relevant information is essential – not
everyone knows the right questions to ask and not everyone will have
attended such a meeting before. The right level of information puts an
attendee’s mind at rest and lets them know that they are being looked
after – for example, informing them that they will be met at the
airport and transferred professionally to their hotel. Including
written details like city information, local weather expectations,
dress code for the meeting, and clear contact details in case of
problems makes travelling to an unknown country much less daunting.
The previous point about early booking goes for meeting venues too.
Engaging with a partner that can draw from a global network of hotels
and in situ ground agencies can add a competitive edge. Negotiating
with a hotel and ensuring that accommodation and meeting space is
secured early gives the organiser much more leverage, while allowing
time to agree more favourable cancellation policies and the active
management of a rooming list. Agreeing contracts with light penalties
in case of accommodation attrition is another way that a skilled
meeting planner protects your budget.
Deciding whether to use five-star properties is an issue which most
people raise. On the surface this looks to be black and white. In
practice, however, a number of differences exist for classes of hotels
globally. While it goes without saying that for modern-day meetings,
hotels attached to casinos, resorts, spas, or advertising themselves as
‘luxury’ properties are out, there are instances where holding a
meeting in a ‘five star’ or equivalent venue may be permitted – or even
advisable. What is more, such properties may offer rates that are
comparable to, or even more competitive than, their lower-rated
neighbours.
The key words to keep in mind here are ‘due diligence’. Working with an
agency with a dedicated venue search team means that you will be kept
aware of the properties that are available for your meetings and, just
as essential, those which are unavailable for your chosen dates. This
can often be the driver behind choosing an appropriate venue and
demonstrates the decision making process involved. Naturally, it also
provides a traceable paper trail to anyone challenging your decisions
on destination and venue further down the line, and can prevent you
from potential exposure to non-compliance.
GUIDELINES, CODES, REGULATIONS & RISK
Tackling the organisation of any clinical meeting without considering
compliance would be like rowing a boat without a life jacket. Since
2007, IFPMA, and subsequently local guidelines, have become much more
stringent, with the perception of meetings involving health
professionals very much at the forefront. Each region and indeed
country has its own interpretation of these regulations. In some cases,
ABPI, CNOM, Mdeon, Farmaindustria for instance, local codes have become
even more rigorous in their approach to the locations, venues and even
views on how much time should be spent by delegates at each event.
Our industry is one of the most heavily regulated. Pharmaceutical
companies are aware of this and have in many cases developed their own,
stringent internal policies on meetings and events. These generally
cover how delegates are treated from their travel arrangements,
accommodation, how much is spent on food and beverage, to financial
limits on gifts and other rules such as what is considered a
permissible business expense.
Meeting organisers with an understanding of potential areas of
non-compliance in certain countries will alert you to this as soon as
they come across something which could create problems for attendees or
sponsors.
A current example of this is the challenges Belgian and French
delegates can face in gaining authority from their countries’ medical
bodies – Mdeon and CNOM respectively – before they are able to attend
any meeting. These organisations analyse the details of the trip, the
reason for travel, spend for each invitee and either ratify or refuse
the application. Not appreciating this process and the intricacies
involved (it can take four to six weeks to complete applications) can
and does result in sites or key opinion leaders being excluded.
Calculating and eliminating risk as far as possible is not confined to
regulatory concerns. Risk exists in almost every area to varying
degrees: security, confidentiality, politically and environmentally.
Understanding this means that a meeting organiser can build measures to
reduce risk into their processes and plan for unforeseen circumstances.
Preparing for every eventuality is impossible, but a sensible emergency
and disaster plan should be the absolute minimum when taking the safety
of attendees into account. Natural disasters are extremely difficult to
plan for, however certain areas of the globe present higher probability
of such events, and having vital information to hand in the shape of
medical contacts, embassies, and even hotel-specific emergency
protocols aid response times. It can help to have experience of what
can and does go wrong, as well as an appreciation of regional cultural
nuances and how to manage these. In various destinations, for example,
extra security would be advisable, whereas in a number of places this
is mandatory.
Confidentiality presents a myriad of concerns, considering that many
meetings take place in ‘public’ places. Basic factors include ensuring
that no competitor is present in the same venue and should be built
into a hotel contract. Other considerations include clearly
communicating the importance of delegates wearing identification at all
times on site, as well as verifying that those people granted entry to
meeting areas are permitted to be there. Printed or digital study
material should be protected and treated as highly confidential, and
meeting areas double-checked for leftbehind documentation following
every session. Signature sheets are doubly important, not only for
security and confidentiality, but also to demonstrate that delegates
were present for training. Recently, one well-known pharmaceutical
organisation was fined a significant amount for not possessing
documentation to prove the attendance of delegates to vital training
sessions. It is also important to ensure the hotel’s staff understands
that your meeting is private and therefore inaccessible to them.
When considering risk at the beginning of your meeting planning
venture, enquire as much as possible about risk, security,
confidentiality and the precautions your partners take to avoid
exposure.
FINANCIAL CONCERNS
In an industry where return on investment, added value, openbook
accounting and strategic outsourcing are the buzzwords, meeting
organisation can present a minefield for the uninitiated. The events
industry can often involve commissions, kick-backs or other incentives
– ones which the modern-day pharma industry has distanced itself from
over the past decade or more.
Finance departments will be looking for a clear outline of meeting
spend, while their outsourcing equivalents will be seeking to
demonstrate best value and business objectives. Clinical operations
teams will be aiming to minimise the impact on study start-up resources
while meeting GCP and protocol requirements.
All of the above pressures can have an impact on the cost a study. Bear
in mind that an average clinical meeting can involve multiple
third-party contracts with various suppliers such as ground
transportation agencies, audio-visual suppliers, translation companies,
and couriers (to name but a few). To manage all of these factors, as
well as to analyse, benchmark all costs and negotiate preferential
rates, is extremely time-consuming. Even so, because these types of
pass-through costs account for between 80 and 90 per cent of all
meeting costs, a good clinical event organiser will be skilled in
effective negotiation with supplier networks to obtain demonstrable
cost savings, concessions and benefits. Being a good steward of a
budget means proper preparation, established vendor networks and clear
financial reporting.
MEETING EXPERTISE
Throughout the whole process it can be easy to forget that a clinical
meeting can have an impact on the life of a clinical trial. Often, such
an event may be the first and only time that a study sponsor, project
team and health professionals get the opportunity to network and
discuss key issues. The quality and effectiveness of the organisation
and delivery of an event – positive or negative – reflects ultimately
on the sponsor and their culture.
Pulling all of the strands together can be a challenge, but if properly
met, it can have a real influence on enrolment numbers and speed,
effective case reporting and data gathering, and produce clear benefits
over an ad hoc, piecemeal approach.
By considering the factors above, and viewing clinical events as an
integral and important component of any study, your next event can be a
high-quality, consistent and well-run clinical meeting.
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