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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)

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

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

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)

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

10 Narrative header options

11 Customized header output sample

12 Narrative body

Macro Parameters

Specification

Output

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.