Methodological approach to the use and interpretation of baseline history of suicidal ideation and behavior Sarah DuBrava Pfizer, Inc
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1 Methodological approach to the use and interpretation of baseline history of suicidal ideation and behavior Sarah DuBrava Pfizer, Inc
2 2010 FDA Guidance In general, suicidality assessments should be conducted at baseline and at all planned visits at which other clinical assessments are to be carried out in a study for which suicidality assessments are considered appropriate. This guidance does not address the complex analytic issues involved in the analysis of the suicidality data that will be derived from prospective assessments of suicidality; these issues will be addressed in separate guidances
3 2012 FDA Guidance In general, in outpatient trials for which assessment of suicidal ideation and behavior are considered appropriate, assessments should be conducted at baseline (the lifetime suicidal ideation and behavior assessment) and at all planned visits at which other clinical assessments are to be carried out. This guidance does not address the complex analytic issues involved in the analysis of the suicidal ideation and behavior data that will be derived from prospective assessments of suicidal ideation and behavior; these issues will be addressed in a separate guidance.
4 Common Summaries Screening visit responses Lifetime Baseline visit responses Period between screening and baseline visits Post-Baseline responses By visit Rolled up Summary Windows: Lifetime Baseline Post-Baseline Visit Schedule: Screening Baseline Visit 1 Visit 2 etc
5 Mock Tables and Figures Window C-CASA Category Treatment A Treatment B Lifetime Suicidal Attempt xx (pp.p%) xx (pp.p%) Preparatory Acts xx (pp.p%) xx (pp.p%) Suicidal ideation xx (pp.p%) xx (pp.p%) Baseline Suicidal Attempt xx (pp.p%) xx (pp.p%) Preparatory Acts xx (pp.p%) xx (pp.p%) Suicidal ideation xx (pp.p%) xx (pp.p%) Post-Baseline Completed Suicide xx (pp.p%) xx (pp.p%) Suicidal Attempt xx (pp.p%) xx (pp.p%) Preparatory Acts xx (pp.p%) xx (pp.p%) Suicidal ideation xx (pp.p%) xx (pp.p%)
6 Mock Tables and Figures Window C-CASA Category Treatment A Treatment B Lifetime Suicidal Ideation or Behavior xx (pp.p%) xx (pp.p%) Suicidal Behavior xx (pp.p%) xx (pp.p%) Suicide Attempt xx (pp.p%) xx (pp.p%) Preparatory Acts xx (pp.p%) xx (pp.p%) Aborted attempt xx (pp.p%) xx (pp.p%) Interrupted attempt xx (pp.p%) xx (pp.p%) Preparatory acts or behavior xx (pp.p%) xx (pp.p%) Suicidal Ideation xx (pp.p%) xx (pp.p%) Wish to be dead xx (pp.p%) xx (pp.p%) Non-Specific active thoughts xx (pp.p%) xx (pp.p%) Active: Method without intent xx (pp.p%) xx (pp.p%) Active: Intent without plan xx (pp.p%) xx (pp.p%) Active: Plan and intent xx (pp.p%) xx (pp.p%) Baseline etc
7 Mock Tables and Figures Post-Baseline Suicidal Ideation and Behavior by Treatment Group Percent of Subjects
8 Treatment Emergent SIB Of the general form: Endorsement of a more severe event than was reported at baseline Definition of treatment emergence can defined for each of the following: Ideation alone Behavior alone SI&B combined Interpretation changes with the definition of baseline
9 Defining Baseline The relevant window of time referred to as baseline can be defined several ways: Lifetime ( Lifetime assessment at Screening plus Since Last Visit assessment at Baseline) Recent History (add a Recent History assessment at Screening plus Since Last Visit at Baseline) The baseline visit ( Since Last Visit at Baseline) Lifetime History Summary Windows: Recent History The Baseline Visit Post-Baseline Visit Schedule: Screening Baseline Visit 1 Visit 2 etc
10 Defining Recent History What time window is a meaningful representation of overall patient status? Is it the same for ideation and behavior? Is it the same across populations? Pediatrics Dementia Schizophrenia Should it vary based on the duration of treatment/follow up?
11 Considerations How do inclusion and exclusion criteria impact these definitions? If patients with significant SIB within the clinically meaningful window are excluded, the difference between short term and longer term baselines is minimized. i.e. if 2 years is used as recent history and as an exclusion criteria, no events at baseline by definition
12 Improvement Improvement in suicidal ideation Of the general form: No ideation or endorsement of only less severe ideation than was reported at baseline Definition of baseline is critical Fewer potentially meaningful definitions arise
13 Thank You
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