WILSON

The Standard Case Report Form: Another FDA Reviewer’s Perspective



Stephen E. Wilson, DrPH Director (Acting) Office of Business Process Support (OBPS) CDER / FDA Creating Clinical Trial Efficiencies Through Standard Data Collection DIA Hot Topic – January 25, 2006 – Arlington, VA



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Disclaimer Views expressed in this presentation are those of the speaker and not, necessarily, of the Food and Drug Administration.



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Assumption: Standards are Good

• Improves efficiency of evaluation of safety and efficacy of investigational treatments

– Communication between sponsor and agency – Development of efficient review environment



• Improve efficiency for clinical research

– Facilitates design and conduct of clinical trials – Facilitates communication between researchers and study sponsor – Integration with the electronic health record



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“Generic” Data Collection Forms*

• Patient Demographics • General Medical History • Specific Medical History (Therapeutic problem oriented) • Clinical Chemistry • Hematology and urinalysis • Urinary, fecal, or other samples • Radiology reports • ECGs • … • 32 examples Spilker, 1991

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“Pitfalls” to Avoid

• Designing CRFs

– – – – – – Request information without adequate instructions Using multiple pages that could be one page Requesting excessive amount of information on one page Using unfamiliar jargon Using a check-off system without all possibilities Using codes that are only relevant to data processors Not collecting sufficient data at baseline or post-treatment Not collecting data at the most relevant time points Not collecting adequate data at relevant time points Collecting unnecessary data

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Determining the amount of data

– – – –



Spilker, 1991



Standard Case Report Forms

What do they mean to this statistical reviewer?



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Motivation

• “Critical Path” – continuous improvement • Science

– 80/20 – Comments



• Clinical trials • Review efficiency (clear, easy to use, understandable) • Data/information/tools standards • EHR – Public/Individual health

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Statistical Review: A Few Considerations

• • • • • • • • Reflection of endpoint – Protocol/Analysis plan Consistent definition of endpoint Annotated CRF Standard data & metadata – SDTM & ADaM Missing data Adequate data Comments – communication Too much data? Data quality.

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Random Advice/Musings

• • • • • • • • • • Full Model – “meta-enterprise” architecture Therapeutic area (sub-specialties) EDC EHR – patients HL7-CDISC Regulations/guidance Human factors/informatics Flexible standards – oxymoron? More than CRFs? Vision vs. next steps

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THANK YOU

wilsons@cder.fda.gov



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