Innovations In Clinical Neuroscience

SEP-OCT 2014

A peer-reviewed, evidence-based journal for clinicians in the field of neuroscience

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Innovations in CLINICAL NEUROSCIENCE [ V O L U M E 1 1 , N U M B E R 9 – 1 0 , S E P T E M B E R - O C T O B E R 2 0 1 4 ] 16 The number of respondents who answered each item was used as the denominator in calculating percentages because a different number of respondents answered each of the questions. RESULTS A total of 132 responses from 50 companies were collected over five weeks for a response rate of 9.1 percent. Respondents with no involvement in SIB assessments in clinical trials at their company were excluded from further analysis, leaving a total of 89 evaluable responses, which represented 39 companies (for an evaluable response rate of 6.1%). About half (52%, 45/87) of the respondents identified themselves as working at a large pharmaceutical company, and about a third (35%, 30/87) at mid- sized companies, while the remainder reported they worked at a small pharmaceutical company or biotech. About 40 percent (36/89) of r espondents were physicians, with the largest specialty (22.5%, 20/89) represented by psychiatrists (Table 1). Thirty-seven of the 89 respondents (41.6%) described their background training as "Other," and in open text comments listed a wide range of disciplines that included basic science, statistics, clinical pharmacology/pharmacist training, project management, epidemiology, social work, and regulatory affairs. In terms of the roles they played in their companies, most respondents (80.9%, 72/89) described themselves as working in clinical development (Table 1). The majority (87.5%, 77/88) reported having worked in the industry for more than 10 years. Factors considered by companies in deciding to include SIB assessments in studies. The most common factors taken into account by pharmaceutical or biotech companies in deciding whether prospective SIB assessments should be included in clinical trials were whether the compound under study was a psychiatric or neurologic drug product; whether it was CNS active; the disease and patient population under study; and regulatory announcements and policies. Nearly half of respondents also indicated that evidence of SIB adverse effects in other drugs of the same class and the occurrence of CNS side effects in Phase 1 studies were important considerations. Patients' ability to understand the wording and provide meaningful responses to SIB assessments was identified as an important factor by about 40 percent of the 83 respondents who answered the question. About 60 percent (51/83) of the respondents identified six or more important factors, and 35 percent (29/83) endorsed 10 or more factors (Supplemental Table 1*). CNS and non-CNS indications for which companies have included SIB assessments in TABLE 1. Respondent characteristics R OLE AT COMPANY* (N=89 RESPONDENTS) N % Clinical development 72 80.9 Medical affairs 11 12.4 Study management 19 21.3 Development operations or project management 17 19.1 Therapeutic area or disease specialist 18 20.2 Clinical safety 10 11.2 Outcomes research 5 5.6 Regulatory 6 6.7 Other 3 3.4 TRAINING* (N=89 RESPONDENTS) N % Clinical pharmacologist 6 6.7 Internist 4 4.5 Neurologist 8 9 Nurse 2 2.2 Physician, other specialist 4 4.5 Psychiatrist 20 22.5 Psychologist 13 14.6 Other** 37 41.6 * Respondents were instructed to select all that apply. ** "Other" encompassed a wide range of specialties, including basic science (biology, chemistry, microbiology, neuroscience, pharmacology), statistics, pharmacist/PharmD, project management, epidemiology, social work, and regulatory affairs.

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