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?

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

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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

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Purpose of Drug Snapshots

• Provide Information to the public about who

participated in the clinical trials for NMEs and

• riginal biologics
• Also includes information on study design, results of

efficacy and safety studies, and whether there were

• bserved differences in efficacy and side effects

among sex, race, and age subgroups

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Snapshots Audience

• Consumers
• Physicians, Statisticians, anyone who is

interested in the data and analyses “(MORE INFO)”

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DTS vs Package Insert

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Snapshots are not a drug label

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

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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