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home > ict > winter 2015 > face value?

PUBLICATIONS

International Clinical Trials Face Value?
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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Face Value?