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 Company logo here www.diahome.org Disclaimer Views expressed in this presentation are those of the speaker and not, necessarily, of the Food and Drug Administration. www.diahome.org 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 www.diahome.org “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 www.diahome.org “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 www.diahome.org • Determining the amount of data – – – – Spilker, 1991 Standard Case Report Forms What do they mean to this statistical reviewer? www.diahome.org 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 www.diahome.org 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. www.diahome.org 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 www.diahome.org THANK YOU wilsons@cder.fda.gov www.diahome.org