Shouldn’t every protocol be “smart”? It may seem like a rhetorical question. How much of the clinical trial data and budget are truly necessary? Are there ways to simplify the process?

As Genentech’s Paul Clarkson, director of data management, explains in today’s podcast, some companies rush to put too much into the plan for a clinical trial.  We caught up with Clarkson at the 2008 spring Leadership Forum of the Society For Clinical Data Management.

As Clarkson tells it, not-so-smart protocols do not reflect too many cooks in the kitchen. Such designs may reflect too few participants. A smart protocol emerges, he says, when extraneous and unnecessary procedures or data elements get added to the plan; sometimes such elements can only be discovered when operationally-oriented individuals like data managers or statisticians become involved.

Designing Trials

Clarkson by no means suggests Genentech has a patent on developing smart protocols. Many companies are doing the same thing. Says Clarkson: “They’re starting to be more thoughtful in a sense of how they think about designing their protocols.”

In some cases, Clarkson suggests having less data could mean that what is collected will be cleaned, gathered and analyzed more quickly. What regulators need is one consideration. Another is what will be needed by commercial colleagues concerned with marketing. A third is administrative data. Or data supporting other data for submission. “It’s good to have more rigor or discussion about why we are collecting that data,” he says. “People are very open to having that discussion.”

Goldilocks Issues

But not all of the elements that wind up in a protocol are there for any of those reasons. Exploring which aspects of a protocol can be tricky. In some cases, Clarkson will use a spreadsheet to show his teams, in a color-coded fashion, the origin or rationale for an element of a protocol. Colored squares in the grid correspond to different stakeholders or company objectives. Uncolored squares may have no raison d’etre. That makes it very clear.

There is danger in protocols that collect excessive amounts of unneeded data, Clarkson says. “There an economic risk of spending money to collect data you don’t really need,” he says, and notes that investigators and even patients may also be unnecessarily drained by a protocol that is needlessly complex. We’ve heard there may be more discussion of the best practices around smart protocols at the SCDM fall meeting, held in September of this year in Dallas. ClinPage will provide an update on such sessions as we learn more about the agenda.

Here’s a link to the podcast (free registration on our site is required.)