Another meeting? Make yours productive
Another meeting? Make yours productive
Here are logistical strategies
Clinical trial sites, as well as study sponsors, could make investigator meetings more successful by following a few key guidelines, a clinical research consultant and author suggests.
"You have to understand about learning styles, adult student needs, and some instructional techniques," says Deborah Rosenbaum, CCRC, CCRA, CCRT, a consultant with Sarrison Clinical Research in Cary, NC. Rosenbaum has written three books with hands-on reference information for investigators, coordinators, and others involved in clinical research.
She provides these tips to improving investigator meetings:
1. Settle logistical needs.
"Typically at the beginning of a trial, a sponsor will want to hold an investigator meeting for multicenter sites to get everyone together and on the same page," Rosenbaum says. "It’s primarily training on the protocol."
The key is finding the most effective way to gather everyone involved, she notes. One method might be to use vendors who will handle travel arrangements and assist in organizing the meeting, Rosenbaum suggests.
Another consideration is whether the meeting will need to take place in person or whether it can be conducted through the Internet, she says. Real time meetings can be held via the Internet, and all participants would be on-line at the same time, listening to a moderator who will answer questions, Rosenbaum says.
"This will minimize time away from the office, which is really an obstacle with investigator meetings," she explains. "Most of what I’ve heard is that these work and are successful, but I’m a strong proponent of in-person interaction."
2. Decide what will be presented.
Typically, the presentation will include protocol requirements and technical aspects of the study, including how to prepare the drug/device, Rosenbaum says. The meeting also will discuss the case report form, going over its different elements and advising the investigator and coordinator on what the intent is for the data being collected so they’ll understand why they need each piece, she adds.
For example, the meeting should focus upon how adverse events will be collected, answering this question: Are you going to record symptoms, including fever, coughing, running nose, or just record it as "flulike symptoms?"
Also, the presentation typically will include a session on good clinical practices, Rosenbaum says.
Sponsors are required by regulations to inform investigators what their responsibility is for following FDA regulations, she reports. So it’s a good idea to cover FDA and other regulations as well as providing instructions for making sure the IRB submission is in compliance with regulations, Rosenbaum says.
3. Spiff up the presentation method.
"Often what you find is people who are presenting will basically read the protocol," Rosenbaum says. "We want to liven it up and make it more interactive and interesting."
For example, the protocol review is intended to reinforce how well the site understands the protocol. This can be done more effectively by breaking up participants in small groups, she suggests.
Then you give each group cards that list each piece of the protocol and study, such as these:
- Get a chest X-ray.
- Get informed consent.
- Administer drugs.
"Then you take the cards and put them in order, according to the protocol," Rosenbaum says. "This is a good way to make sure people understand that it’s always important to have the informed consent form signed before anything else, and it shows them how the rest of the procedures flow."
It also shows participants the baseline parameters and reinforces the order of study activities in a fun and active way, she adds.
Another innovative teaching method is to use case studies.
"You can do a lot with adverse events," says Rosenbaum. "A case study might be if a patient’s wife calls in and says the patient is unconscious." Participants are asked to describe what they would do, what they would ask the woman, etc.
"If the study will use a lab test kit, then make sure you have a lab test kit at the meeting for investigators to look at and have a sample of investigational product there," she adds. "Often even clinical research associates don’t see the product until they monitor the study, so it is helpful for everyone to become familiar with it."
Clinical trial sites, as well as study sponsors, could make investigator meetings more successful by following a few key guidelines, a clinical research consultant and author suggests.Subscribe Now for Access
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