Magazine Article | December 7, 2010

The Ideal Virtual Solution For Clinical Studies

Source: Life Science Leader

By Dax Kiger, director of strategic development, UniversalProcon & Trifecta Multimedical

A clinical study manager recently wrote to me and asked, “What is the ideal resource to compare the various Web solutions that are available to train investigators?”

This is a question that does not have an easy answer, and it is one of the most repeated queries I receive from both sponsors and CROs. The short answer … there is not a reliable, all-in-one source for comparing Web solutions on an equal basis. In the clinical area of training sites, monitors, and support personnel, there are as many needs as there are applications.

However, before you find the application, you first need to determine the goals and objectives for the training or meeting itself. It is best to narrow this down into three main categories, detailed below:

For all investigator meetings, the primary objective is to certify and track the training itself. Due to strict audit requirements and the critical nature of a clinical trial, it is important that sponsor organizations have a method to verify training has actually taken place.

This is a very common reason for bringing people together; usually in this case, it is a “meeting of the minds.” An organization will want to gather key opinion leaders (KOLs) or thought leaders to collaborate on a particular issue or specific findings. Typically, this is the primary training goal for a meeting such as an advisory board or results meeting.

There are many reasons why networking is so important, especially when considering the success of a clinical trial. Sponsor organizations or CROs may feel it is pertinent to have “face time” with sites and build relationships with primary investigators or KOLs.

After considering the purpose of the training, you need to look at additional factors, including geography, protocol stage, and time frame, all of which have a major impact on how you choose a training solution. These factors determine the utilization of a face-to-face meeting versus a live Web solution versus a fully virtual “on-demand” solution.

Study teams often turn to live Web solutions when they are under pressure from “above” to cut costs or when they are falling short on recruitment of sites. These solutions are ideally used for one-on-one personal interaction because they tend to be less expensive solutions designed primarily for peer-level collaborative meetings. That is a valid niche, but not for clinical communication that needs to be certified, tracked, and reused multiple times over the life of a study.

The best rule of thumb is to find an on-demand solution that can be part of a total meeting replacement strategy: All of the content traditionally delivered at a face-to-face meeting is captured through video or audio, and training is completed via an online platform. Since no live meeting takes place, this solution offers the most flexible delivery to your audience.

Straying from a WebEx style tool and consistently choosing a certified on-demand solution allows all sites to be trained in a small window of time, with a consistent standard of delivery on a global basis. The content can reach more support personnel working on the enrollment and reporting processes. Another benefit is that all content has been captured, making it available at any time throughout the life of the study and easily configured for updates, amendments, and for unanticipated training with site turnover and site additions.

With various applications to choose from, the selection process can be overwhelming for study teams. But implementing the points illustrated above can make the process much less painful, while improving the quality of training for clinical personnel.