The importance of this conference cannot be overestimated, because it can dramatically affect patient enrollment and retention, as well as data quality. Thus, an effective start-up meeting can mean the difference between a study that concludes quickly with few problems and one that takes an inordinate amount of time, patience, and money to complete.

The purpose of an investigator’s meeting is, at least superficially, to

• introduce the researchers to one another,
• introduce the study to the researchers as a group, and
• provide appropriate study conduct training for the participating physicians and coordinators.

Although it is true that research centers will receive hands-on training and orientation from a study monitor during what is known as the “site initiation visit”, in terms of obtaining clean, high-quality data, the benefits of having personnel from all sites meet in one place, at one time, to hear the same information, are invaluable. Of similar importance is the opportunity for physicians to discuss the risks and benefits of a new medication among themselves and with scientists from the sponsoring company. All these meetings ensure that the sites share the same understanding of the research they will conduct.

Of course, the start-up meeting has another, less obvious goal. This subtler purpose is to convince researchers that the sponsoring pharmaceutical company and its products are “cutting edge”. Admittedly, an investigator’s meeting is as much about marketing as about training; if investigators leave the meeting with a lack of confidence in the company, its drugs, or its clinical trial, the results may prove disastrous. On the other hand, investigators who return to their practices excited about a potential new drug, its clinical research program, and its sponsor work harder to meet enrollment goals, retain enrolled patients, maintain follow-up on discontinued patients, and collect high-quality research data. Further, they are more apt to prescribe marketed medications from the same company to their non-research patients. So expending the time, energy, and capital necessary to produce a high-quality meeting is a win–win situation: The sponsor gains a valuable researcher and customer, while the researcher gains a trusted partner for future efforts.

Creating the perfect meeting
As Martha Stewart might say, the key to hosting a good party is to prepare adequately for the event. It is certainly no different with corporate meetings. Numerous professional conference planners are available to assist in meeting planning, several of whom even specialize in orchestrating clinical investigators’ meetings. However, most organizations like to plan these events themselves. Further, if a contract research organization (CRO) has been retained to manage the trial, pharmaceutical companies usually will require that the CRO plan and host the start-up meeting. So what planning is necessary, and what makes for a good conference?

First, when it comes to a start-up meeting, you really do get what you pay for, and, as in real estate, location is everything. Typical meetings in the United States last two days and range from the less expensive (e.g., a gathering at a Las Vegas hotel) to the extravagant (e.g., a Caribbean cruise). In addition, although it may not always be possible to carefully time a conference, the location must be chosen with some regard to the weather. For example, a meeting in Phoenix, AZ, is not recommended in late summer, and a trip to northern Maine would not be advisable in December. This is not to say that a winter meeting at a ski resort would be a bad idea, but careful consideration should be given to the distances that research personnel will travel and to weather conditions that might complicate their trips. The things that contribute to a good location are its elegance, its proximity to an airport, its privacy, and the availability of local entertainment.

Finally, when making hotel reservations, in addition to booking the proper number of guest rooms, it is important to make certain that the hotel has sufficient meeting space and adequate catering facilities for the program.

Once the location has been reserved, the next step is to make the guest arrangements. Only the principal investigator and one to two research coordinators from each site should be invited to the meeting. It should be made clear that meeting attendance is required and that families or other guests will not be accommodated. (On occasion, the principal investigator cannot attend the meeting; in that case, it is best to have at least a subinvestigator participate.)

In terms of the specific travel arrangements, it is usually advisable to retain a private travel agency. Ideally, site personnel should contact the agent directly, and the agent, following certain guidelines, should reserve flights and rental cars using a direct billing procedure. Researchers should not be asked to pay anything out-of-pocket except incidentals, and all sites should be given reimbursement forms to request repayment for certain of those items.

Because the sponsoring company usually provides the food, the next step is to select a menu. Although breakfast and lunch may be casual and informal, dinner is usually a special occasion. At a meeting in Dallas, for example, one pharmaceutical company rented a country and western club for the evening and provided ribs, live music, and mechanical bull riding for the guests. By contrast, another pharmaceutical company held a meeting in New Orleans that featured a formal six-course meal at an elegant, atmospheric French Quarter restaurant. Although the mood of these events is as different as their locations, it is usually wise to plan functions that the attendees will consider special or even extraordinary.

The remaining arrangements are mundane. Welcome gifts for the guests should be selected, equipment for the meeting presentations reserved, and handouts and other business-related materials prepared. The formal content of the presentations should obviously be planned.

Once all the details are attended to, it’s time to play host.

Conducting the meeting
The gifts, dinners, hotels, and flights compose the obvious marketing aspects of the conference. The meeting itself is strictly business. Or is it?

Although the content is certainly pure business, the style and manner of the presentations, the responses to participant questions, and the knowledge base presented to the researchers land more firmly in the marketing arena. Therefore, it is as important to pay attention to the choice of presenters and presentations as it is to plan the dinners and gifts.

Most conferences split the actual meeting content into two parts: protocol and data collection. On the first day, researchers are introduced to critical staff at the pharmaceutical company (and CROs). They are presented with medical reviews of the investigational drug and the results of its previous trials. In addition, the protocol’s objectives and general efficacy measurements are formally reviewed. On the first day of the conference, it is also common for researchers to be reminded of the requirements and obligations that are imposed on them by FDA study conduct regulations.

The second day often consists of breakout sessions for the investigators and coordinators. The purpose of the sessions is to provide the researchers with critical information that is specific to their roles in the trial. For investigators, a breakout session usually involves a highly specific discussion of the characteristics of the targeted patient population. It also consists of discussions about accurately conducting efficacy measurements and the daily requirements of the study protocol. For coordinators, the breakout session generally involves a page-by-page review of the Case Report Form (the repository of collected data that must be maintained throughout the study), and a discussion of patient recruitment and retention techniques. Finally, a review of the protocol from a “nuts-and-bolts” management perspective is generally included.

Given the differences—and the sometimes-unusual requirements unique to each clinical protocol—the agenda for an investigator’s meeting is highly fluid. But the issues of concern at all meetings, and the planning requirements for them, are about the same. The goals are always to train the personnel in study conduct and to excite them about doing the project.

The monies required to host successful meetings are often large. However, the costs of omitting the start-up conference, or of hosting a less than successful event, are much greater. Therefore, a good meeting is one of the best investments a company can make in its research projects.