Collecting Quality Data in Psychiatric Clinical Trials

“Speed without quality – like the quality of a swimmer’s stroke during a race – just doesn’t get you the win that you’re aiming for.” – Krista Armstrong, VP for Strategic Development

Krista was talking about quality in patient recruitment in our latest webinar, but really it’s a thought that covers all areas of psychiatric clinical research.

We all know that studies involving psychiatry drugs may be uniquely challenging. Ensuring that trial data accurately captures a compound’s safety and efficacy potential requires that you account for challenges inherent in working with a mentally ill population. Observing changes in the disease under study is partly a subjective process, and that creates risk of undue influence that the patient and/or investigator may not recognize.

To further complicate things, not all symptomatic improvement in mental disorders can necessarily be tied to the product under study. Some changes may result from unrelated factors whose therapeutic effect erodes the efficacy signal of a potential treatment.

One thing that helps in collecting quality data is what we call “The Partnership Factor.” It sounds simple and obvious, but collaboration between the CRO, the sponsor, and the site is critical to driving success and achieving the goals to the study. When all three are in sync on understanding the end game, and there’s buy-in on how best to achieve those goals, the quality of your execution of your study is maximized in every way. But more often than not, the teams aren’t always in sync.

Learn more from Krista Armstrong, Vice President for Strategic Development, and Susan Kozauer, Senior Medical Director, in their webinar, Conclusive Results: Strategies for Collecting Quality Data in Psychiatric Clinical Trials. Have a look!

 

Author Details

Aaron Tonkin
Phone Us Now
Email Us Now