Patients in Trials of Depression Drugs Called Unrepresentative
The National Institute of Mental Health commissioned the organization STAR*D (Sequenced Treatment Alternatives to Relieve Depression) to examine the effectiveness of a variety of antidepressants, specifically in patients who would be most likely to receive them in clinical practice. However, most of the participants used in the study would normally be excluded from pivotal clinical trials. 77.8% of STAR*D’s study participants failed to meet inclusion criteria that is normally present in phase III drug trails. These individuals would be less likely to achieve clinical responses than those who met the criteria for phase III drug trails, 22.2% in this study. The researchers conducting the study defended their position saying that they used a broader inclusion area to increase generalizability to real-world practice. “Phase III trials do not recruit representative treatment-seeking depressed patients… given these between-group differences, the smaller efficacy sample is clearly not representative of the more inclusive, treatment-seeking population,” they said. Click here to read an article from RedOrbit.com that discusses the study’s findings more.