Nowadays, conducting a clinical study is more complicated than ever. Clinical studies have more complex protocols, new technologies, and increased regulatory scrutiny. It has made study execution more challenging.
Regardless of the rise in difficulty, what matters is that a sponsor collects good, clean data that reflect how well its drug works. This increased difficulty raises a question. Why don’t sponsor companies put more effort into working with sites to ensure that data quality will be built in up front and study operations managed at the site level efficiently and effectively?
Simply thinking about the amount of information a site must understand about a protocol is enough to make one’s head spin. This information includes:
- inclusion/exclusion criteria
- procedures related to each visit
- adverse event reporting
- lab procedures
- recruitment strategies
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. The expectation is that doctors and study coordinators will flock to these to learn about protocol at hand, ask questions, and prepare themselves to take part in the study.
78% of respondents found the overall usefulness of investigator meetings to be “Good” or “Excellent.”
This is an age-old practice, but is it still viable? Should steps be taken to provide training that is not only more effective but delivered in a more efficient manner as well? A closer look at the characteristics of investigator meetings over my next few blog posts will help to answer these questions.
A good place to start is with the sites themselves. Do they feel that investigator meetings are worthwhile?
Consider the findings of a recent CenterWatch Monthly survey of 102 investigative sites. In the survey, 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 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 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. At these meetings, investigators can make new sponsor contacts to ensure participation in future trials. Either way, having sponsor personnel and site staff networking early on can help establish better communication during the study.
The opportunity to discuss protocol specific subjects directly with the sponsor company is another reason that meetings have value. Open discussions about inclusion/exclusion criteria are very helpful. This develops 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. This can appeal to their professional side and help 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 another critical aspect of in-person investigator meetings. Discussing questions and concerns while getting instant feedback is something both sponsors and attendees value.
In addition, attending these meetings give both the doctor and study coordinator a unique opportunity. They can learn about the protocol without the myriad of distractions that exist in their office back home. This change of pace helps the attendees focus on the task at hand. It also allows 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. Bringing people together builds a sense of community and ensures better coordination among the sponsor and its sites. Many investigators and study coordinators see the attendance of such a meeting to be a perk of study participation. This is especially true when it is held in a desirable location. No matter the reason, a positive experience at the meeting can lead to increased effort on the site’s part.