Cutting-edge investigator training vital to protect human safety, particularly in wake of new I.G. report.(Training)

A recent report by the HHS Office of the Inspector General found that FDA each year audits fewer than 1% of the clinical trial sites in the U.S., and these tend to focus on the accuracy of study data, not on human safety (See October issue, p. 1).

Thus, it is vital for human subject safety that sponsors and clinical investigators work to obtain the best possible training at clinical study sites. Best methods include learning modules with interactive selftests, web conferences, interactive and multimedia elements, and training tracking websites.

The use of these methods should be followed with certification and follow-up training reinforcement, said William Cooney, the president of Medpoint Communications, Evanston, IL, during a Nov. 7 ExpertBriefings.com webinar.

During the event titled "Protecting Patient Safety in Clinical Trials: The Training Gap," Cooney stressed that good training develops quality content, delivers training to all target learners, reinforces training with testing and follow up, and documents progress.

He noted that current investigator training practices, such as standard meetings and conferences, are inadequate.

These meetings usually are fly-in two days away from the clinic and are now less lavish and fun due to new regulations.

"The quality of training content and delivery is poor. It does not usually reach the target learners and uses expensive and inconvenient formats. Training progress is not usually documented and does not address the training needs of international sites," said Cooney.

Typical training sessions have presenters who are scientists, not trained educators. There is little audience interaction and they tend to lose interest.

Also, he noted, normally the only ones sent to training sessions are the investigator and one coordinator. "The reality is that most sites have four or five staff members, and there is steady staff turn-over. In fact, the sessions normally train lest than 50% of target learners."

Training is not very well documented at these events, he said. There is minimal learning assessment and little data capture of audience responses. Data is not centrally stored and the rates of training completion are unknown.

Poor training leads to poor human subject protection: unknown training results, slower and less accurate processing of subjects, preventable errors, and monitors are burdened with training duties, not ensuring human subject protection.

Better solutions are available, Cooney stressed.

Web conferences, for example include the following benefits:

1. Live, moderated learning;

2. Lower costs;

3. More convenient;

4. Reach more people per site;

5. Interactive elements - polling, chat;

6. Multimedia elements - video, animation; and

7. Broadband availability.

Web conferences can be made into "hybrid" meetings, with both onsite and remote participants. "These are the best of both worlds. You get relationship building, lower costs and increased reach," Cooney said.

Another method - learning modules - features study-specific presentations, with digital recording of voice, video and slides. There is a navigation tool set with options including video animations and scrolling text.

Learning modules allow you to assess training levels, he noted. There are mutiple-choice self-tests and are based upon learning objectives.

One myth to overcome, he noted, is that investigators will object to being tested. "If you train, you MUST test," he said.

Another option is training websites. Users normally log in and progress is tracked. These sites drive high levels of utilization and study visibility.

By Joseph Pickett, Managing Editor

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