Innovations In Clinical Neuroscience

SEP-OCT 2014

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

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[ 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 ] Innovations in CLINICAL NEUROSCIENCE 15 The most common challenges in implementing suicidal ideation and behavior assessments included cross- cultural differences in acceptance of S IB assessments (40%); obtaining adequate baseline history (36.8%); obtaining translations (35%); investigator/rater discomfort with asking about suicidal ideation and behavior (32%); and inadequate training of raters to administer suicidal ideation and behavior ratings (30%). Conclusion: Among sponsors surveyed, the implementation rate of suicidal ideation and behavior assessment in central nervous systems studies is very high. Most have used the Columbia-Suicide Severity Rating Scale. Challenges regarding standardization of retrospective assessment timeframes and differing approaches to summarizing and analyzing suicidal ideation and behavior-related study data were frequently reported. These results suggest that inconsistent reports of suicidal ideation and behavior within study datasets may occur and that integration of data across studies remains a concern. INTRODUCTION In September 2010, the United States Food and Drug Administration (FDA) issued an initial draft guidance requiring prospective assessment of suicidal ideation and behavior (SIB) in clinical trials of central nervous system (CNS) active compounds under development for psychiatric and neurologic indications and in certain other conditions (e.g., obesity, smoking cessation). 1 The guidance lists two objectives for introducing these systematic assessments into clinical trials: 1) to better identify patients in clinical trials who experience SIB to ensure they are adequately treated and 2) to enable more complete and timely collection of data on SIB events during trial conduct. Following the appearance of the guidance and its revision in August 2012, 2 prospective assessments of SIB were broadly implemented in clinical studies spanning a wide range of indications, patient populations, geographic regions, and cultures. To better understand the impact o f this development on the clinical trial process, the International Society of CNS Clinical Trials and Methodology (ISCTM) formed a work group comprising stakeholders involved with clinical trials (investigators, raters, sponsors, vendors) to survey current approaches to SIB assessment following the issuance of the FDA draft guidance. In the summer of 2011, the ISCTM SIB Assessment Workgroup (ISAW) conducted an initial online survey of clinical trial site experiences and attitudes toward SIB data collection. 3 A total of 972 evaluable responses were collected, and the majority of respondents had personally conducted SIB assessments. The results revealed that although SIB assessments were readily incorporated into clinical trials and improved patient safety, there were continuing challenges for sites in certain areas such as obtaining an accurate baseline lifetime history, training in administration of the SIB rating scale, and assessment of SIB in cognitively impaired populations. 3 To complement the previous survey of clinical trial sites, in August 2013, the ISAW conducted an online survey regarding pharmaceutical sponsor experience and practices in the conduct of prospective SIB assessments in clinical trials. The survey addressed topics regarding the types of studies that typically monitor SIB, factors considered in deciding if a study should include SIB assessments, which assessment tools or rating instruments were used, how SIB screening and baseline assessments are done, how subjects reporting active SIB during a study are managed, and what challenges companies encounter implementing SIB assessments in their studies. METHODS Survey questionnaire development. Potential challenges and issues encountered by pharmaceutical sponsors in implementing SIB assessments in industry clinical trials were identified i n discussion with stakeholders within and outside the ISAW. Based on these discussions, 30 items were developed for inclusion in the survey. Four questions elicited demographic and background information on the respondent, including type of training, type of company worked for (large, medium, or small pharmaceutical company or biotech), role in the company, and years of experience in industry. Respondents were asked whether they were involved with the implementation of SIB assessments in clinical trials at their company. A "final draft" version of the survey was piloted with several non-workgroup participants from pharmaceutical and biotech companies prior to being finalized and implemented online using Survey Monkey (Supplemental Document 1*). Sample identification. A list of email addresses was assembled from the ISCTM membership mailing list and from a contact mailing list maintained by a vendor that provides clinical trial scientific services to pharmaceutical companies. The survey was sent to 1,447 industry employees at 178 pharmaceutical and biotech companies. Representatives from contract research organizations (CROs), vendors, or academic and government institutions were not included in the survey. Data were collected from August 15, 2013, to September 20, 2013. A cover email accompanying the survey invitation encouraged respondents to discuss the survey questions with colleagues, if necessary, to provide information that best represented their company's practices and experiences with SIB assessments in clinical trials. Data analysis. Continuous variables were summarized using descriptive statistics. Categorical variables were summarized using frequency and percent tabulations.

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