Inside Investigator Meetings

Why this age-old industry staple is missing the mark for many and what can be done to remedy the situation.
Jun 01, 2008
By Pharmaceutical Technology Editors


PHOTOGRAPHY: GETTY IMAGES
Nowadays, conducting a clinical study is more complicated than ever. More complex protocols, new technologies, and increased regulatory scrutiny have all made study execution more challenging. Regardless of the rise in difficulty, what really matters is that a sponsor collects good, clean data that reflect the reality of how well its drug works. So the question becomes, why don't sponsor companies put more effort into working with their sites to not only ensure that data quality will be built in up front, but that study operations at the site level will be managed efficiently and effectively?

Simply thinking about the amount of information a site must understand about a protocol—inclusion/exclusion criteria, procedures related to each visit, adverse event reporting, lab procedures, recruitment strategies—is enough to make one's head spin. Considering that sites may be participating in several studies at any given time, often with different sponsors, it becomes clear that there is a lot of room for error on the site's part.

Given the complexity of studies and the responsibilities of sites, do sponsor companies sufficiently support sites in this regard? The common practice, of course, is to hold an investigator meeting that doctors and study coordinators are supposed to flock to in order to learn about the protocol at hand, ask questions, and otherwise prepare themselves for participation in the upcoming study. This is an age-old practice, but is it still viable? Do steps need to be taken to provide training that is not only more effective but delivered in a more efficient manner as well? A closer look into the characteristics of investigator meetings will help to answer these questions.

The good

A good place to start is with the sites themselves. Do they feel that investigator meetings are worthwhile? According to a recent CenterWatch Monthly survey of 102 investigative sites, 78% of respondents found the overall usefulness of investigator meetings to be "Good" or "Excellent." That certainly bodes well, although skeptics may point out that the respondents really have no point of reference; investigator meetings are all they know. Still, based on these results, it would seem that sites do feel that investigator meetings have something of value to offer.

The opportunity to network is often cited as one of the most important benefits of attending investigator meetings. An investigator who has no experience with the study drug (or with clinical studies in general) can pick up some good information by talking to those with more experience. In addition to the scientific networking, investigators also network in a traditional business sense by making new sponsor contacts in an effort to ensure that they will be utilized in future trials. Either way, having sponsor personnel and site staff get to know each other early on can help with establishing better communication during the study itself.

Having the opportunity to discuss protocol specific subjects directly with the sponsor company is another reason that meetings are seen to have value. Open discussions about inclusion/exclusion criteria are helpful in developing better investigator understanding of not just "what" the criteria are, but "why" as well. Having an open discussion about the scientific background of the study and study drug is a good way to educate the investigators while appealing to their professional side and helping them feel they are a part of the sponsor's efforts to bring the study drug to the masses.

The interactivity of meetings in general is yet another critical aspect of in-person investigator meetings. Regardless of the topic at hand, having a dialogue and getting instant feedback on questions and concerns is something that both sponsors and attendees place significant value on.

In addition to the idea of interactivity, attending an investigator meeting gives both the doctor and study coordinator the opportunity to learn about the protocol without the myriad distractions that exist in their office back home. This change of pace can help the attendees to better focus on the task at hand and allow them to immerse themselves in the study details for a couple of days, potentially leading to better comprehension of the protocol.

Lastly, there are the intangibles. Building a sense of community by bringing people together can ensure better coordination among the sponsor and its sites. Many investigators and study coordinators see the attendance of such a meeting (especially when held in a desirable location) to be a perk of study participation. Irrespective of the reason, a positive experience at the meeting can lead to increased effort on the site's part.


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