Finding the Best Path to a Clinical Protocol Design

Can’t get people out of their silos?

You’re not alone.

Problem: An early-stage company needed to demonstrate Proof of Concept for a novel therapy, but the organization could not reach agreement on a clinical protocol design.

My client Peter, the Program Executive, vented his frustration to me:

“Dr. C [the Clinical Director] withdraws, withholds information, doesn’t inform me or the program team about anything, comes up with a suboptimal design, gets his boss on board, the Portfolio Review Committee rejects the proposal, and we end up losing a lot of time. This has happened a couple of times already.”

The Portfolio Committee told the team that the only solution was to bring in outside experts.

Solution: Instead of blaming Clinical, I helped the Program Executive step back.

• What was fueling the negative cycle?
• What made Clinical believe that going it alone made sense?
• What could the Program Executive himself do to break the cycle?

We discovered that the Program department unintentionally made things worse. While complaining that Dr. C worked behind the scenes with his boss on the protocol, Peter worked behind the scenes with his boss on the schedule. Each side was confident they knew best. When one pushed back, the other pushed harder.

Our turning point was reframing Peter’s problem from “get Clinical on the program” to “find the best way to test whether the compound will succeed.”

For the upcoming meeting with the outside expert, Peter’s first instinct was to e-mail Dr. C a deadline for his slides. Instead, I helped him plan a 1-1 conversation where he asked Dr. C to formulate the scientific questions that were most important to answer. Peter then planned the consultant meetings around Dr. C’s questions. Motivated by the opportunity to explore new scientific avenues, Dr. C became deeply engaged in finding a better approach.

Peter described his new perspective: “I make sure that if the Clinical Director needs help, I’ll come through for him.”

Results: A novel clinical study was designed and endorsed by all the team members, the Portfolio Committee, and outside consultants as the most efficient way to test the critical hypotheses for clinical success.

For a free consultation on how to improve your organization’s effectiveness contact Merle at mkummer@kummerconsulting.com