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Almost four out of five investigators prefer e-meetings to on-site ones, and virtual training sessions are less time consuming and more cost efficient for the companies sponsoring them.
In today's world of clinical research today, almost every process is coming under scrutiny to see if it can be performed better, faster, or cheaper. One research activity that is ripe for re-engineering is the investigator meeting, which in its traditional form can be expensive, time-consuming, and less than effective.
The overriding mission of the investigator meeting is to prepare study site staff to enter patients into a new clinical trial. This is a training challenge—and a daunting one—as trials grow more complex and study sites increasingly vary in experience, competency, and location.
Unfortunately, investigator meetings have traditionally been organized for speed rather than quality and have seldom incorporated the basics of good training. But this is starting to change. In the last few years, the clinical research community has experimented with new approaches to investigator meetings, including the use of live Web conferences and Web-based training centers.
Enough practical experience has been accumulated that it's now possible to draw some conclusions about these new formats. The good news is that they can lower costs, save time, improve quality, and reach more of the target audience. Taken together, they have the potential to achieve one of the pharmaceutical industry's most basic goals: improved research productivity.
Almost every large pharmaceutical company has conducted at least a pilot program of investigator meetings via Web conference or e-meeting. Most have had positive experiences, and most e-meeting programs are expanding. These meetings require careful planning plus extensive technical and production support. But when properly planned and implemented, they can deliver significant benefits, including:
Cost savings Without the need for air and ground travel, hotel lodging, dining, and so forth, a full-service e-meeting costs about one-fifth as much as a traditional on-site meeting. A single e-meeting typically yields savings in the range of $125,000 to $200,000. Across a large research program, savings can amount to $5 million to $10 million annually.
Convenience and preference By eliminating travel time, an e-meeting can save participants one to two workdays—a significant amount for busy VIP medical audiences. A database of evaluations filled out by more than 2,000 investigator e-meeting attendees showed that almost four out of five US investigators (79 percent) prefer the e-meeting format to on-site travel. The same database yielded positive scores on items such as "Was the information clearly presented and easy to follow?" (98.6 percent favorable), and "How was your overall experience?" (88.8 percent favorable).
High attendance rates It is possible to conduct e-meetings that generate attendance rates as high as or higher than traditional on-site meetings, that is, in the 90-100 percent range. But it is only likely to happen when the e-meeting is supported by a comprehensive invitation campaign. To some audiences, a "Web conference" can seem less important than an on-site meeting. To compensate for this bias, the invitation process needs to convey the importance of the meeting and include a series of reminder communications continued throughout the day of the event. At the same time, experience shows that e-meetings have a higher rate of participation by primary investigators and less substitution by sub-investigators.
Study team productivity Some study launch programs involve investigator meetings held in various regions of the world—consuming a great deal of time and causing significant wear and tear on study team members. A similar series of e-meetings would require only a fraction of the time and would enable the study team to pursue other goals.
Capturing and measuring attention The most common question about investigator e-meetings is "How do I know they're paying attention?" This is a fair concern, because e-meetings, especially long ones, can tax the attention span of participants. There are two strategies to address this concern:
First, the e-meeting must be interesting, so people want to pay attention. With some advance planning, it's easy to incorporate mark-up tools, live video, and simple animations to increase the session's entertainment value. In addition, interactive elements, such as audience polling, chat boxes, and live Q&A, will help participants to stay involved and engaged throughout the entire event.
Second, it's easy to track and document attendance and attentiveness. For instance, attendance can be tracked using log-on data for both the Web conference site and the telephone conference. In addition, attentiveness is often measured by informing participants that polling and chat box responses are mandatory and individually tracked. Widespread experience has shown that these measures are well accepted by audiences and result in documented levels of participation by 80 to 90 percent of attendees.
Hybrid meetings Companies don't have to make an all-or-nothing choice between a traditional on-site meeting and an all-virtual Web conference. Rather, study teams should consider a hybrid meeting that combines on-site and remote audiences in a single live training event. Hybrid formats can provide the best of both worlds, offering personal contact and more intense training for some audiences, while delivering convenience, low cost, and high attendance for others. Hybrid formats include the "attendee choice" model, in which participants can choose to travel on-site or stay home, and the "coordinator on-site" model, in which coordinators travel for more in-depth training, while busy investigators participate in a core session by Web conference.
Some drug developers have begun to create study-specific Web sites, where they can post resources such as study documents and forms, amendments, newsletters, and FAQs to support the training of study site staff. This site (or "e-portal") can also be used to provide access to recorded versions of the presentations made at the study launch meeting.
This tactic is particularly well suited to investigator e-meetings, where presentations are already in digital media. It is important to note, however, that raw recordings—which can be boring and hard to navigate—require skillful post-production in order to transform them into training programs that are user-friendly and suitable for a range of target audiences.
In addition, experience has shown that Web sites devoted to training resources can deliver great value, but not every such Web site does. One common error: producing a quality Web site without driving target users to it. The solution is to actively promote the Web site and provide incentives for using the training resources.
When produced correctly, however, study-specific e-portals can offer:
Extend reach A typical investigator meeting is attended by one investigator and one coordinator from each study site. The problem with this design is that the average study site has three or four additional persons who will perform the roles of investigator or coordinator over the course of a given study. (This is based on a survey of study teams from leading pharmaceutical and biotechnology companies.) In the past, there has usually been no formal program to train site staff who did not attend the launch meeting. This responsibility has been left to the site staff who did attend, or added to the duties of field monitors. An e-portal with self-training modules is a far superior way to extend training to all staff.
Reinforce learning It is well established that training is not effectively achieved by a single experience. Traditionally, though, it's fair to say that investigator meetings have been conducted as massive one-time data dumps. A training e-portal addresses this gap by allowing study site members to revisit material from the study launch meeting and reinforce what they've learned. Additional reinforcement tactics include the use of mid-study Web conferences and periodic e-newsletters that contain links to e-portal resources.
Address English as a second language Clinical research is increasingly conducted at study sites where most or all of the staff speak English as a second language (ESL). For instance, a typical investigator meeting in Europe is conducted in English for audiences that are 80 to 90 percent ESL. Because ESL skills vary greatly, this raises major concerns about training comprehension and retention. The ideal solution would be to translate all training into native languages for target learners, but this method can prove both costly and time-consuming.
A training e-portal, even if it is delivered entirely in English, is an excellent alternative. Self-training modules allow users to pause and repeat, so they can control the pace of learning. (Imagine for a moment you are an ESL learner, and think of the "fast-talkers" you know on study teams!) Self-training modules can include scrolling text of presenter commentary, a benefit to the many ESL learners who read English more easily than they can listen to it. The bottom line is that comprehension will skyrocket for many ESL learners.
Assess learning Training without assessment runs counter to good training practices, yet rarely has "testing out" been part of investigator meetings. A training e-portal offers an excellent platform for providing self-tests for study site staff. Learning assessment methods can be used to:
Better Documentation Among the greatest benefits of a training e-portal is that it can serve as a true learning management system (LMS) that tracks and documents training completion. The LMS not only houses training resources, but provides each learner with a scoreboard that shows the completion status of each module and activity. This may comprise launch training modules, mid-study meetings, protocol amendments, and update training, among other tools.
In addition, the Web site can also allow field monitors to view training information for the sites they manage. The LMS serves as a central database that documents training activity across a clinical trial or even a series of trials. This documentation can be invaluable in proving to regulators that adequate training was provided to protect the safety of patients in clinical trials.
Lower costs It costs about $2,000 for a single participant to attend an on-site investigator meeting. The per-capita cost of a training e-portal is more variable, driven by the number of target learners and the richness of the Web site. Generally, though, a high-quality e-portal can impart similar training for a fraction of the cost of an on-site meeting.
By now it's fair to say that many companies have completed "concept testing" of e-meeting and e-portal systems, and these programs are ready for broader use. From a training perspective, they have been proven to correct many flaws of the typical investigator meeting—from tracking what investigators have learned to being able to include more participants. E-meetings and e-portals also provide practical benefits in convenience, time savings, audience preferences, and lowered costs.
It stands to reason that if study site staffs are better trained, they will be more prepared to enroll patients in a trial, and then perform those trials more quickly, consistently, and efficiently. This is where the re-engineered investigator meeting can make a big contribution to the ultimate goal of research productivity.
Bill Cooney is founder and CEO of MedPoint Communications in Evanston, Illinois. He can be reached at Bill.Cooney@medpt.com