You are going to make 773,618 decisions over a lifetime, according to a poll conducted by the makers of the Puzzler Mind Gym 3D game. And you’re going to regret 143,262 of them. If you are a sponsor of clinical trials, one of your decisions should be to sit down with your contract research organization (CRO) managers and tell them you know there will be mistakes along the way during the clinical trial, said Rick Morrison, founder and president of Comprehend Systems, a clinical trials software company.
While many factors can lead to errors, the human factor is by far the most significant contributor, with 35–70% of all errors attributed directly to human beings, according to The Center for Error Management.
The bigger mistake, Morrison said, is in not using the inevitably of errors as a way to build trust between sponsors and sites. He advises sponsors to sit down in the early stages of the process. “Say ‘Look, I expect things to go sideways. My default assumption is that things are going to go sideways. That’s ok, but what I want is for you to come forward,’” he told attendees of the 15th Clinical Performance Metrics & Analytics Summit hosted by ExL Events in Philadelphia in December.
Sponsors would be well-advised to tell the CRO the best way to address errors is to do it together, and to work on a mitigating plan rather than pointing blaming fingers. It’s “spectacular” when such cooperation happens, Morrison said. However, “The problem is that not every company can do it because of the fraughtness of the relationship,” he noted.
Morrison advises leveraging proactive communication skills to improve the situation. “Talk to the CROs, [and demonstrate you understand] they have different challenges,” he said.
Flexibility is also key. Too often, CROs have “sponsors who are dictating how they have to do their job, which [might be] different that how they’ve ever done it before,” Morrison said. The result? The CRO is slower and tentative, “then the sponsor gets mad at them and they feel that they’re in a” lose-lose situation and may become “super defensive” from feeling mistrusted, he added.
Author: Michael Causey