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International Clinical Trials

Planning for Success

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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Andy Thurstan joined MD Events in 2007 to develop business opportunities in Europe and support growth in the US. Based in Manchester, England, Andy was part of the team which led the company’s expansion and establishment in the Russian Federation during 2010. A trained journalist, Andy moved into corporate communications for a UK-based educational software company, helping to develop business proposals and tenders and win multi-million pound contracts with publicly-funded institutions such as the BBC, the Department for Education and Skills, the Department of Work and Pensions and various educational organisations. Email: andy.thurstan@md-events.com
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