ISCTM Suicidal Ideation & Behavior Assessment Working Group

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1 ISCTM Suicidal Ideation & Behavior Assessment Working Group ISCTM Meeting February 19, 2013 Current Co-chairs: Co-Chairs-Elect: Adam Butler Michelle Stewart Phillip Chappell Douglas Feltner

2 Welcome! Brief introductions AGENDA Review WG Mission Statement Presentations of 4 possible 2013 projects o Larry Alphs o Phil Chappell WG transitions o Chairs o Recruiting new members

3 ISCTM Mission Statement The International Society for CNS Clinical Trials and Methodology (ISCTM) is a multi-disciplinary independent organization, devoted to promoting advances that address strategic clinical, regulatory, methodological and policy challenges that arise in the development and use of CNS therapeutic agents. This work is accomplished through partnership with persons in academia, industry, government, policymaking, and the public.

4 ISCTM Principles Improving the lives of our patients through excellent science Many stakeholders Patients, Clinicians, Investigators, Statisticians, Regulators, Policy-makers, Public International Non-commercial, non-promotional Mutually critical Mutually respectful Pre-competitive and/or collaborative Active participation is strongly encouraged

5 Our WG Mission Continue to advance methodologies and valid tools (accurate, sensitive, & reliable) for the assessment and study of SIB in the context of clinical trials Foster scientific inquiry & discussion among interested stakeholders from a variety of disciplines and areas in pre-competitive space Inform the use of these tools in clinical trials to determine treatment impact

6 Accomplishments to Date Submitted comments on 2010 and 2012 FDA Draft guidances on SIB assessment in clinical trials Conducted global survey on SIB assessment experiences at CNS clinical trial sites 2 posters presented (ISCTM & NCDEU) 1 manuscript submitted Collaborated on Feb 2013 symposium on current SIB assessment issues

7 2013 Project Proposals

8 Clarifying SIB Definitions Issue: Some terminology and conditions around suicide is not consistent or well defined. Research in this field requires standard understanding of terms SIB Work group would: Identify terms and conditions that need clarification Develop working definitions Vet working definitions with the field Publish results and share with regulatory authorities; etc Data source: Potentially a field survey Deliverable(s): A survey and a paper or series of papers Timelines: 1-2 years Proposal 1

9 SIB Working Group: SIB Definitions Proposal 1 Some terms requiring clarification (others should be identified by the working group) suicide, suicidal ideation; suicide intent, suicide plan; passive suicidal ideation Aborted attempt Interrupted suicide attempt Preparatory suicidal behavior

10 SIB Working Group: SIB Definitions Proposal 1 Conditions requiring clarification Definition of time frames for meaningful collection Other important parameters of suicide

11 SIB Working Group: Proposal 2 Further Analysis of Validation Database Issue: Database developed by L Alphs and David Sheehan is incompletely analyzed and additional value that addresses important considerations for the field could be gained by further work on it. SIB Work group would: Work with database located at Janssen; Develop amplified analysis plan based on original protocol Complete additional analyses and interpret them Develop posters and papers for broad communication Data source: ISST-Plus/STS/C-SSRS validation database Deliverable(s): Posters and a paper or series of papers Timelines: 2 years

12 Protocol Proposal 2 JANSSEN SCIENTIFIC AFFAIRS, LLC Version number: 2.0 Final Version 2.0 Drug number: Not Applicable MEDICAL AFFAIRS PROTOCOL Trial number: N/A Clinical Phase: Not Applicable Title Sponsor: Validation Study of InterSePT Scale for Suicidal Thinking Plus (ISST-Plus), Sheehan Suicide Tracking Scale (S-STS) and Suicide Severity Rating Scale (C-SSRS): Consistency of Mapping to Classification Algorithm of Suicide Assessment (C-CASA) Janssen Medical Affairs, LLC.

13 Impulsivity Proposal 2 IMPULSIVITY Not at all A little Moderate Very Extremely Topic How strong was the impulse (urgent need) to plan or to act in any suicidal way? Ability to Restrain/Suppress How difficult was it for you to suppress or to restrain impulses to plan or to act in any suicidal way? Desire to Restrain/Suppress How much did you not want to suppress or to restrain the impulse to plan or to act in any suicidal way? Memories Modifier How much did your memories make you not want to suppress or to restrain the impulse to plan or to act in any suicidal way? Events Modifier How much did external events make you not want to suppress or to restrain the impulse to plan or to act in any suicidal way?

14 Hopelessness Proposal 2 HOPEFULNESS Not at all A little Moderate Very Extremely Topic How much did you lose hope that your life would get better? Ability to Find Hope How difficult was it for you to be hopeful that your life would get better? Desire to Find Hope How much did you not want to be hopeful that your life would get better? Memories Modifier How much did your memories make you not want to be hopeful that your life would get better? Events Modifier How much did external events make you not want to be hopeful that your life would get better?

15 Impulsivity/Hopelessness Proposal 2 Overall Caution/Impulsivity How impulsive/cautious are you in your day to day life? Overall hopeful/hopelessness How hopeful/hopeless are you in your day to day life? Extremely Cautious Extremely Hopeful Very Cautious Very Hopeful Moderate Cautious Moderate Hopeful In the middle In the middle Moderate Impulsive Moderate Hopeless Very Impulsive Very Hopeless Extremely Impulsive Extremely Hopeless

16 Survey of Sponsor Experience in Proposal 3 Implementing SIB Assessments in Clinical Trials Issue: Lack of systematic information on sponsor practices & experiences in implementation of SIB assessments in industry sponsored clinical trials SIB Work group would: Create the survey tool Develop a list of companies (large and small pharma, US and ex-us) to survey May need to identify specific contacts within the companies Administer, collect and analyze the data Disseminate the findings in poster presentations and papers Data source: Results of an online global survey (Monkey Survey) Deliverable(s): Posters, presentations and a paper Timelines: 1-2 years

17 Possible Sponsor Survey Topics How does your company decide which studies should include SIB assessments? What types of studies done by your company typically include SIB assessments? Therapeutic areas, Indications, Phase of development What approach does your company take to the analysis of SIB data? How is baseline defined for analysis of change from baseline between treatment groups? What SIB assessment tools has your company employed? CSSRS, STS, ISST-Plus, Other What inclusion/exclusion criteria are typically used at screening to identify patients at risk of SIB? At imminent risk of suicide based on investigator s clinical judgment Proposal 3 Positive response on an SIB assessment tool indicating presence of active suicidal ideation (plus intent, method, or plan) or history of suicidal behavior What look back period(s) are used at screening for suicidal ideation? for suicidal behavior? What provisions are included in protocols to address the evaluation and treatment of subjects identified as being at increased risk of SIB? Are such subjects typically allowed to continue in the study and if so, under what provisions? What challenges has your company encountered in implementing SIB assessments?

18 Development of a Proposal 4 Pre-Competitive SIB Assessment Database Issue: Lack of a publicly available large SIB assessment database for datamining purposes, limiting our ability to systematically examine methodological challenges and the impact of policy changes SIB Work group would: Develop a high-level proposal Type of data requested and how the data would be mined Technical issues Legal and IP issues Conduct initial feasibility assessment Level of interest in a sample of pharma companies Potential collaborations such as with the FNIH Depending on the results of the feasibility assessment Develop detailed proposal & timelines Identify participant companies & resources Implement the plan Data source: Clinical trial SIB data held by pharma Deliverable(s): Posters, presentations and multiple papers Timelines: 2+ years (?)

19 SIB Assessments Database Proposal Proposal 4 Types of SIB data and ancillary data to be requested Indication Age of subjects Trial design, SIB inclusion/exclusion criteria, provisions for dealing with at risk subjects How the data could/would be analyzed Technical issues such as how the data would be anonynimized and transferred and how/where the database would be constructed, maintained and administered IP protection Legal and contractual matters Availability and access to the data base (who, for what purposes, under what conditions) Resources required

20 Recruiting New Members SIB Assessment WG is seeking new members in 2013 All current members of ISCTM are welcome to submit a request Membership is at the discretion of chairs If interested, please contact Adam Butler (adam.butler@bracketglobal.com) Michelle Stewart (michelle.stewart@pfizer.com) Phil Chappell (phillip.b.chappell@pfizer.com) Doug Feltner (feltnermd@gmail.com)

21 Dinner Meeting Summary Group reviewed WG Mission statement Presentations on proposed 2013 projects Clarification of SIB terms/definitions Post hoc data analysis of validation study for 3 instruments Sponsor survey Compiling SIB data from several pharma Clear objective

22 Summary - Continued Developed criteria for evaluating proposals Do-able by WG (all volunteers) Builds on what we have accomplished to date Guides field w/r/t clinical trials Clear objective

Welcome. International Society for CNS Clinical Trials and Methodology

Welcome. International Society for CNS Clinical Trials and Methodology Welcome International Society for CNS Clinical Trials and Methodology 2018 Autumn Conference Advances in Clinical Trial Technology: Impact on Methodology and Signal Detection 15-16 October 2018 Marina