Co mmunic a ting HT E Ac ro ss Po pula tio ns: Cha lle ng e s a - PowerPoint PPT Presentation

Co mmunic a ting HT E Ac ro ss Po pula tio ns: Cha lle ng e s a nd Oppo rtunitie s

“ Variability is the law of life, and as no two faces are the same, so no two bodies are alike, and no two individuals react alike and behave alike under the abnormal conditions which we know as disease.” - Sir William Osler (1849 – 1919)

I s the re a rig ht numb e r?

4 FDASIA 2012: Section 907 In the past years, stakeholders have been concerned about adequate and • equal inclusion of women and minority groups in clinical trials. Congress directed FDA to take a closer look at and report on the inclusion • and analysis of demographic subgroups in applications for drugs, biologics, and devices In August 2014, FDA delivered its Action Plan to Enhance the Collection and • Availability of Subgroup Data The plan includes three overarching priorities for subgroups: • 1. Quality of Data 2. Greater Participation 3. Increased Transparency

5 Snapshots Brief History 2014: Pilot Program • January 1, 2015: Snapshot written for every New • Molecular Entity (NME) and Original Biologic approved Goal to publish 30 days after approval • Does not apply to previously approved drugs •

6 Purpose of Drug Snapshots Provide Information to the public about who • participated in the clinical trials for NMEs and original biologics • Also includes information on study design, results of efficacy and safety studies, and whether there were observed differences in efficacy and side effects among sex, race, and age subgroups

7 Snapshots Audience Consumers • Physicians, Statisticians, anyone who is • interested in the data and analyses “(MORE INFO)”

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DTS vs Package Insert

10 Snapshots are not a drug label Snapshots Prescribing Information Intended for public Intended for healthcare professionals Consumer-friendly language Technical language Focus on subgroup data and analysis Comprehensive resource for drug information Links to FDA reviews Not linked to FDA reviews 30 days after drug approval Published with drug approval 10

Important Questions 1. Is there enough data to make conclusions about efficacy and safety for all subgroups? 2. How many patients per subgroup are needed? 3. When is generalizability ok? 4. When differences among subgroups are seen, when are differences clinically meaningful?

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T HANK YOU! Any Que stio ns? DrJo hnWhyte @ g ma il.c o m @ DrJo hnWhyte