A LABOR SAVING MACRO FOR PROGRAMMED PATIENT …narrative sections to be programmed (6) Narrative...
Transcript of A LABOR SAVING MACRO FOR PROGRAMMED PATIENT …narrative sections to be programmed (6) Narrative...
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A LABOR SAVING MACRO FOR PROGRAMMED PATIENT NARRATIVES
VINEETH KURNALA PRAFULLA GIRASE
BIOGEN 10OCT2017
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There should be brief narratives describing each death, each other serious adverse event, and those of the other significant adverse events that are judged to be of special interest because of clinical importance. These narratives can be placed either in the text of the report or in section 14.3.3, depending on their number. Events that were clearly unrelated to the test drug/investigational product may be omitted or described very briefly. In general, the narrative should describe the following:
12.3.2 Narratives of Deaths, Other Serious Adverse Events and Certain Other Significant Adverse Events
the nature and intensity of event, the clinical course leading up to event, with an indication of timing relevant to test drug/investigational product administration; relevant laboratory measurements, whether the drug was stopped, and when; countermeasures; post mortem findings; investigator's opinion on causality, and sponsor's opinion on causality, if appropriate.
In addition, the following information should be included: q Patient identifier q Age and sex of patient; general clinical condition of patient, if appropriate Disease
being treated (if the same for all patients this is not required) with duration (of current episode) of illness
q Relevant concomitant/previous illnesses with details of occurrence/duration Relevant concomitant/previous medication with details of dosage
q Test drug/investigational product administered
What is a Patient narrative? (ICH E3 Guidelines)
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3 Our Traditional Process
(1) ICH subjects
patient profiles + Data listings
(programming group)
(7) Implement safety group’s feedback
and finalize (Medical writing
group)
(3) Manual sifting through patient
profiles (Medical writing group)
(2) Narrative template
population (Medical writing
group)
(6) Out for review (Safety group)
(5) Full narrative draft
ready (Medical writing group)
(4a) If Serious
Adverse Event: CIOMS form
(8) Include in the study
CSR (Medical writing group)
(4b) If Adverse Event
of Special Interest (AESI):
AESI forms
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4 Programmed Patient Narrative (1st Step at Automation)*
*Girase P, Boisvert D, Kurnala V, “Programmed Patient Narratives Using SAS® ”PhUSE 2016, Paper AD09.
(7) Include in the study
CSR
(1) Identification of
narrative sections to be programmed
(6) Narrative review by
safety group for non-programmed
sections
(5) Addition of other narrative sections based on CIOMS
or AESI forms
(4) Delivery of FINAL Qced programmed narratives to MW
(2) Development and
approval of programmed
narrative specification
(3) Development of
programming code to generated programmed
narratives
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5 Macro based narrative generation process
(1) Identification of ICH
subjects and sections for narratives
(3) Addition of other
narrative sections by MW based on CIOMS
or AESI forms
(2) Development, QC and
delivery of macro based programmed narratives to MW on
standardized specification
(6) Include in the study
CSR
(5) Narratives review by safety group for non-programmed sections
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Specification for structure of narratives (Double-blind or Open Label Studies)
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Specification of algorithms (Double-blind or Open Label Studies)
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Specification for structure of narratives (Studies with different parts)
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9 Design of SAS ® Macro
Study variables
** Patient information; %let patid = SUBJID; %let dummyid = DUMMYID; ** Demographics; %let dmdata = libref.adsl; %let dmwhere = %str(); ** Treatment labels; %let trtlbl1 = Placebo; %let trtlbl2 = Active; ---------------------------- ----------------------------
(3) Driver File narratives-
<studyid>.sas
(1) Patients qualifying under ICH/AESI
criteria for narratives
(2) Macro
m-narratives.sas
(4) Output RTF file
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10 Narrative header options
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11 Customized header output sample
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12 Narrative body
Macro Parameters
Specification
Output
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13 Conclusion
q Robust solution applicable across studies with similar design.
q Saved hundreds of manual hours of narrative writing. q CDISC standards helped with automation. q Could not automate sections that needed human
interpretation.