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Table 1 Subject selection issues identified across the CNS spectrum

From: Site-independent confirmation of subject selection for CNS trials: ‘dual’ review using audio-digital recordings

All reviewed subjects Challenged cases (% of all cases reviewed) Not approved (% of all challenged cases)
Inadequate documentation to support the diagnosis 68 2.7% 19 27.9%
Insufficient symptom severity (too low) 75 2.9% 41 54.7%
Symptom severity too high (above entry criteria) 44 1.8% 28 63.6%
Presence of comorbid medical diagnosis 30 1.2% 5 16.6%
Presence of comorbid psychiatric diagnosis 67 2.7% 29 43.3%
Substance abuse/dependence 29 1.2% 12 41.4%
External confounding factors 50 1.9% 11 22.0%
Unreliable/unassessable subject or informant 13 0.5% 6 46.2%
Other protocol-specific study criteria 28 1.1% 17 60.7%
Total of all submitted subjects (n = 2,515) 404 16.1% 168 6.7%