Drug Development 101: How to Build a Good Review Team, Tip #1

We at Acumen write a lot of documents and work with many cross-functional teams. We get a front row seat to see what works (and what doesn’t) when it comes to document development. Before building a document, you need to build a review team, which basically boils down to the following:

• Keep it lean

• Stay in your lane

• Know your roles and responsibilities

• Set realistic expectations

Creating a Lean Team

When it comes to document review teams, less can be more. We often find that there is a misconception among our clients that the more eyes on a document the better. But what really matters is not the number of eyes but having the right eyes. With too many reviewers and/or the wrong reviewers, the document’s progress is poised for a precipitous descent into chaos and inefficiency. A good review team will have only one delegate from each contributing function. For a protocol, this might include 6 to 7 members (Stats, Medical, PK, PD, Clin-Ops, Regulatory). Review teams for some other documents should be even smaller. Once you are pushing double digits, chances are it’s too many.

Advice: Limit the writing/review team to only the contributing SMEs and the Senior Managers required by SOP. External KOLs and consultants may add value to the review, when engaged early and for specific input. Identifying a back-up for each function is also a good idea to avoid delays in case the primary reviewer becomes unavailable.  

Justin McLaughlin

CEO, Acumen