Inside Investigator Meetings (Part 4 – The Root of the Matter)

Regardless of how one looks at the current state of investigator meetings, there is no question there is room for improvement. Like any improvement initiative, the first question the sponsor needs to ask is, “How does this benefit the bottom line?” The value of an investigator meeting needs to be properly defined and evaluated. Any subsequent improvement efforts should be done with that value proposition in mind.

To get their drugs to market, sponsors need to collect clean, objective data that speak to their drugs’ safety and efficacy. This, of course, is where the investigators come in. The focus of investigator meetings should align with this higher level objective. It is not much of a leap to assume that better training will lead to better protocol and procedure comprehension. These, in turn, will lead to better data quality, higher enrolling sites, and an overall improvement in a site’s efficiency.

Thus, the question shouldn’t be “How do we improve the meetings so that attendees are happier?”  The question should be “How can we improve the training so that attendees can do a better job conducting the study?” That is, how can you reconfigure the concept of the investigator meeting to meet the higher level objective?

Initial Challenges

At the onset of any study, there are a number of site initiation challenges to overcome. What does site staff know about the study? When do they learn it and for how long will they remember? Did all members of the study site team read and understand the protocol? Do they all have the same baseline knowledge? All of these questions need to be properly addressed if sites are to be capable of helping the sponsor to meet its high-level objectives.

 

Also, there is the regulatory aspect to consider, as “GCP compliance and training issues top regulators’ concerns.” By addressing and overcoming these challenges, the sites will be better prepared to conduct the study. Also, experienced site personnel are not forced to endure the standard “one size fits all” training.

One way to do this is to create a series of baseline assessment tests for site personnel. For example, use case studies on the subject of adverse event reporting to test how proficient an investigator is at assessing severity, causality, and reporting actions. Better yet, tailor case studies can so that presentations are actually relevant to the study at hand. Those who do well on the baseline assessment (i.e., experienced investigators) can go through an abbreviated training on the subject. Those who do not do well must then go through the standard, lengthier training.

Other Issues

There is another issue that bears mentioning. It is the conflict that exists between the sponsor’s motives for holding investigator meetings and the site’s motives for attending. Often, they are the same: to educate that site staff with regard to the protocol and its related procedures. However, as mentioned, there are investigators who attend for strictly business reasons.

In the CenterWatch survey, study coordinators consistently cited investigator meeting attendance as a perk of their job. They felt it was critical to their professional development. Should sponsor companies be paying hundreds of thousands of dollars per meeting just so study coordinators are happier in their jobs? There is undoubtedly a benefit to having coordinators attend the meetings—to share recruitment ideas with sponsor contacts or to develop a better relationship with their investigator. But whether that benefit outweighs the cost is debatable.

There is another side to this argument. It is the sponsor’s responsibility to put in time and effort to plan a meeting that an investigator feels is worth attending when weighed against his or her other commitments (not to mention those of study coordinators, etc.). A colleague of this author was at an investigator meeting to do a vendor presentation. While checking in at the registration desk, an investigator walked up. The investigator took a look at the agenda, and demanded to be flown back home immediately (and he was). An extreme case perhaps, but how many other attendees have at least thought of doing that?

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