CenterWatch’s Deborah Borfitz recently interviewed Linda Barr, RN, director of regulatory affairs at Clinipace, for her “Time may be right to makeover the investigator brochure” piece that ran in last month’s print edition.
The article points out that the investigator’s brochure (IB) is intended to equip clinical researchers with what they need to make an unbiased risk-benefit assessment of the experimental medicine involving human subjects. But by virtue of its size and complexity, the IB rarely gets a thorough reading, and anecdotal evidence suggests the time and expense invested in its creation reap a relatively modest return. Deborah’s question posed to industry experts – is it time to makeover the investigator brochure to address these issues?
Deborah finds that readability of the IB can be improved in many cases, and regulatory guidance documents give sponsors the latitude to do so via style of presentation. Many clinicians complain that most IBs are lengthy and relatively boring. According to Linda:
“In the quest to squeeze as much data and information into the fewest possible number of pages within the allotted timeline, readability can fall off the priority list of some sponsors.
After repeated updates, IBs also can become fairly disjointed if no one is routinely examining the document in its entirety. A coherent IB provides summarizations of key points, an overview on risks and benefits and the data to support that overview. If available, references to the literature sometimes can substitute for overly lengthy data presentations.
According to Linda, delayed or piecemeal updating of the IB is the most likely culprit of the document’s inconsistency with the protocol and sponsor directives.
For a lot of companies, I think the IB is the last thing on their list [of needed document updates]. It’s almost like a little orphan child who is thought about only after everything else. But when you think about it…the IB eventually becomes the package insert for the approved product. So keeping the IB succinct and up to date throughout the clinical development program is one way [for sponsors] to stay ahead of the game.”
If you would like to learn more about IBs and why site initiation visits are ideal times to familiarize clinicians with what’s in the IB and how to use it to their advantage, please register for our free webinar on the Joys and Woes of Clinical Trial Start-Up.