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Why following one consistent playbook for trial management should be at the core of outsourcing partnerships in drug development.
Consistency is a theme that ran through the expert panel discussion on successful partnerships, the resultant article from which can be found here. Consistency in outsourcing models, consistency in communications, and consistency in trial management were all discussed as cornerstones to a fruitful business relationship.
Without consistency, outsourcing partnerships suffer. Inconsistency leads to
chaos, dysfunction, micromanagement, dissension and, ultimately, failed processes. To ensure consistency, our panel experts recommend a playbook. Simply put, it is the guide for how clinical trials will be managed in their respective company’s. The guide is updated, and all parties are updated and trained on changes.
Well, you might say, “I’ve managed trials all my life, I don’t need a guide.” You may be able to run a trial blindfolded. But the ah-ha moment I had was when one expert said, “Everyone has a different philosophy on how to manage a study.” This industry has undergone a lot of change, mergers and acquisitions in the 30-odd years of wholesale clinical trial conduct and outsourcing. What you learned at, say, the former PharmaNet or Kendle may not be how the former Sandoz would run a trial.
How trials are run at your company may be a mish-mosh of all of your managers previous jobs. It’s like driving on the New Jersey Turnpike on a Sunday. You’re all from another state, going to another state, and you all know how to drive, but you don’t drive like, say, how a New Jerseyan would drive at rush hour. It just doesn’t work well and it’s chaotic.
In conferences, I have heard how one study team will try a new technology in a trial, never to realize a team in their same company was also using it. That one team chooses one type of software and another team picks something else. It is also entirely possible that both teams work with the same CRO, so now you have two teams using the same CRO but on different software. This is also true of an example shared in the article of using different outsourcing models in the same therapeutic area. Maybe 40% of the trials get one model and 60% another model. The experts say, “Just don’t do it.” If you want consistency-internally or with your external partners-just pick one.
In Ken Getz’s column in our April/May issue, he details the macro issues that are hindering collaborative effectiveness between CROs and sites and sponsors. And many of these were touched on in our panel. But put in a financial context, he states, “Clinical operations activities are deeply dependent on collaborative effectiveness. Approximately $26 billion was spent on CROs in 2016 largely to execute clinical trial activity worldwide.” And, he also emphasized, there is no indication that this trend will reverse.
This is the way drug development is structured, and the more effective the partnership, the more potential for efficiencies that save money, bring drugs to market faster, and support the advances in technology. I know we tend to want to believe our way is best, but sometimes when your company is following one playbook in one direction, you can focus on consistent excellence rather than inconsistent chaos.