thank you for joining ismpp u today!€¦ · gpp3 authors & expert editors answer your...
TRANSCRIPT
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THANK YOU FOR JOINING ISMPP U TODAY!
The program will begin promptly at 11:00 am EDT
November 18, 2015
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ISMPP WOULD LIKE TO THANK . . .
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. . . the following Titanium and Platinum Corporate Sponsors for their ongoing support of the Society:
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ISMPP ANNOUNCEMENTS
• This program qualifies for 1 credit towards recertification• Registration for the 2016 European Meeting of ISMPP is now
open!• Call for abstracts now open for the 12th Annual Meeting of
ISMPP. Deadline is Friday, January 8, 2016• Be sure to complete the 12th Annual Meeting Roundtable
Survey – help us select topics YOU want to discuss. Survey closes next Tuesday, November 24th
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2016 EUROPEAN MEETING OF ISMPP19-20 January, London
• A focus on practical skills that drive successful publication delivery
• GPP3, RWE, data & financial transparency, guidelines & regulations, journal selection and new journal features
• Peer exchange, expert-led roundtables, member presentations, extended Q&As, interactive panel discussions
• Attendees will leave with ideas they can use the day they return to work
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September 30, 2015
Day 1: Tuesday 19 January 2016 - Highlights• GPP3 Panel Discussion
GPP3 authors & expert editors answer your questions
• Real World Evidence and Publications With Richard White, Oxford PharmaGenesis
• Roundtables Attendees can join three different tables, some eligible for CMPP credit
• Data & Financial Transparency Reporting Representatives from EMA, EFPIA and industry
• Evening Poster Presentation & Networking Reception
2016 European Meeting Preview
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September 30, 2015
Day 2: Wednesday 20 January 2016 - Highlights• Publishing & Journals: Practical Considerations in 2016
• SPEED Research Authors have 10 minutes to present their research
• Parallel sessions: Other Guidelines & Regulations Attendees select two from three 45-minute sessions:
1) Copyright2) Corporate Integrity Agreements3) EQUATOR
• Keynote Address: Publications Pioneer Vitek Tracz on “The Future of Publications”
2016 European Meeting Preview
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CMPP™: COULD YOU BE A MENTOR?
ISMPP is seeking volunteers to provide mentorship to individuals considering sitting for the exam or who have questions related to recertification
• Must be CMPP™ certified and willing to be listed on the ISMPP website
• Please email [email protected] to register your interest
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FOR YOUR BEST ISMPP U EXPERIENCE . . .
To optimize your webinar experience today:• Use a hardwired connection if available• Use the fastest internet connection available to you• If you are accessing the presentation over your computer,
please be sure to increase the volume of your computer speakers
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QUESTIONS…
• To ask a question, please type your query into the Q&A box
• To ensure anonymity and that all panelists receive your question, please choose the drop down box option, "ALL Panelists"Otherwise, all audience members will be able to see your submitted question
• We will make every effort to respond to all questions
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NOTE: Make sure you send your question to “ALL Panelists”
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BIO-STATS PRIMER AND WORKING COLLABORATIVELY WITH STATISTICIANS FOR PUBLICATION PLANNING PROFESSIONALS
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INTRODUCTIONS
• FACULTY: Jay Hsu earned his bachelor degree in Business Mathematics from Soochow University in Taiwan in 1983. Then he served 2 years in the army before he came to the US to receive his MS and Doctoral degree in biostatistics from The University of Alabama in Birmingham. Dr. Hsu was then a research assistance professor at University of Alabama in Birmingham for 4 years teaching biostatistics in medical school and school of public health. He also worked for the Blue Cross and Blue Shield of Alabama as a consultant to detect medical frauds in Medicare/Medicaid for 2 years. In 1999, Dr. Hsu changed his career to the pharmaceutical industry. In the past 16 years, Dr. Hsu worked for Wyeth, Novartis, and now for Sunovion since 2008.
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INTRODUCTIONS• FACULTY: Meg Franklin has over 10 years of experience in the health economics
and outcomes research arena. She has consulted for pharmaceutical consulting companies, and spent several years in academia as an Associate Professor at the Presbyterian College School of Pharmacy in South Carolina. Over the last decade she has written numerous scientific publications, conducted retrospective database studies, developed economic models, drafted value messages, and provided strategic consulting to pharmaceutical companies. Her primary expertise is in research design and methodology, particularly retrospective analyses. She holds a PharmD and PhD from the University of South Carolina.
• Dr. Franklin has worked across a myriad of therapeutic areas. Recent areas of focus include the following: oncology (pancreatic, lung, and breast cancers, multiple myeloma, melanoma, and chemotherapy induced nausea and vomiting), hepatitis, diabetes, cardiovascular disorders, epilepsy, multiple sclerosis, hemophilia, and rheumatoid arthritis. She also has experience working with rare/orphan diseases. Prior to entering the HEOR arena, she completed an ASHP accredited pharmacy practice residency and worked as a clinical pharmacist.
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INTRODUCTIONS
• MODERATOR: Tom Drake has been involved in medical communications for over twenty-five years. He began his career in the pharmaceutical industry as a product and marketing manager, with postings in the United States, Europe and the Far East. In 1990 Tom founded and launched the healthcare marketing trade publication,Product Management Today (PMT). He was publisher and editorial director for its first six years. PMT targeted over 10,000 healthcare marketers and helped pioneer the focus on marketing management’s professional growth and development. Tom has been involved in most areas of medical communications including: global publication planning, continuing medical education, thought leader development, HEOR and Market Access, digital and web based communications, consumer healthcare communications, market research and healthcare marketing. He has been an active member of ISMPP since 2008 and most recently was chair of the ISMPP-U committee and remains a committee member. In 2014 Tom launched the Global Outcomes Group, an independent agency supporting HEOR and Market Access communications for the bio/pharma and medical device industries.
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DISCLAIMER
• Information presented reflects the personal knowledge and opinion of the presenters and does not represent the position of their current or past employers or the position of ISMPP
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OBJECTIVES
At the end of this presentation, attendees should be able to:• Gain an understanding of statistical methods for medical and
life sciences• Understand the role of biostatisticians in industry-supported
clinical research • Understand how biostatistics and medical affairs can best
collaborate together • Have knowledge of educational opportunities and/or ways to
improve clinical research skills as medical publication professionals
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HOW BIOSTATISTICS WORK WITH MEDICAL AFFAIRS FOR PUBLICATION SUPPORT
Jay Hsu, PhDExecutive Director, Biostatistics
Sunovion Pharma Inc.
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OUTLINE
• Who are we? Where do we stand in company’s organization chart?
• What do we do?• Why biostatistics and Medical Affairs (MA) need to work
together?• What are the problems?• How much work to do? • How do we handle it?
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WHO ARE WE IN COMPANY ORGANIZATION CHART?
• In my company:CDMA
MA Data Science ClinOps ClinRes …
MIMSL
HEOR…
StatsPGMDM
CDMA: Clinical Development and Medical Affairs; MI: Medical Information; MSL: Medical Service Liason; HEOR: Health Economic & Outcome Research; Stats: Statistics; PGM: Programming; DM: Data Management; ClinOps: Clinical Operation; ClinRes: Clinical Research
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WHAT DO BIOSTATISTICIANS DO?
• Participate study design, protocol development, & study conduct for all phase studies
• Statistical Analysis Plan (SAP) developments• Study Tables/Listings/Figures (TLFs) • Clinical study reports• Regulatory submissions/Health Authority interactions
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WHAT DO BIOSTATISTICIANS DO? (CONT.)
• Publication Supports– Discuss requests for post-hoc analyses with MA– Perform post-hoc analyses for posters, manuscripts, and
presentations– Review and QC all MA materials are essential
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“THINGS TO CONSIDER”
• FTEs (full-time employees) for study conduct are usually accounted for
• No FTEs or limited resources in biostats and programming groups to handle Health Authority requests and publication supports
• Once a drug is approved by Health Authority, a large volume of clinical requests from MA to support the medical plan
• All requests from MA require meetings/discussions before any work performed
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HOW MUCH WORK IS THERE?AN EXAMPLE OF ONE DRUG ON MARKET
• For this specific drug on market, the company achieved the following in 2014:– Manuscripts: 15– Posters/Presentations: 146– Plus many PMRC (Promotional Materials Review Committee)
and MSL materials and others– 5 Phase III studies database locked, tables/listings/figures
generated, and CSR completed– 5 Phase III studies ongoing– 1 sNDA preparation
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WHAT ARE THE PROBLEMS?
• Competing tasks: clinical studies, regulatory submissions, and MA requests
• Requests from MA to biostats are sometimes late– No time for meetings and discussions– No time for performing analyses
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WHAT ARE THE PROBLEMS?
• Usually requires huge amount of time – To think carefully whether the requests are clinically
and/or statistically sound– To program summaries and statistical
inferences/analyses– To review and QC posters, presentations, and
manuscripts• Not enough time for review/comment before final
documents
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RESOURCE IN BIOSTATISTICS/PROGRAMMING
• If enough resource in both biostats and programming in-house: – Great, but unusual!– Due to some special expertise and/or software availability
reasons, sometimes still need help from CROs or external consultants. For example, modeling and simulation, special statistical methodologies … etc.
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RESOURCE IN BIOSTATISTICS/PROGRAMMING(CONT.)
• If in-house programming support is not enough:– Seek for external help, and the earlier, the better
• Acceptance check or validation sometimes needed– Or, biostats needs to jump in and get hands dirty
• Biostatistician's programming capability is essential• Be able to produce summaries in table format (no
need to be pretty) so that medical writers can easily read and understand the results.
• Validation may be a problem!
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RESOURCE IN BIOSTATISTICS/PROGRAMMING(CONT.)
• If no biostats/programming support in-house: – A very tough situation! – Seek for external help– Quality! May need to 100% rely on others (external help)
without any checking– Cost! Maybe expensive
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HOW DO WE HANDLE IT?
• Introduction of statistical analysis request form (SARF)– Requester’s info, date of request– Detail of the request, – Rationale and Hypothesis– Where will the data be presented or used?– Format of outputs– Deadline– Approval for the request– Biostats/programmer information– Completion/Delivery date– Programs/outputs file names and locations
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HOW DO WE HANDLE IT? (CONT.)
• Biostatisticians are “gatekeepers”:– Ensure requests from MA are feasible, – Requests are clinically and statistically sound– Pre-meeting to go over each request is essential to get
agreement and to make strategic decisions (prioritization) if too many requests at the same time
• Last minute request is usually not acceptable
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HOW DO WE HANDLE IT? (CONT.)
• Validation – Required, but sometimes it has to be flexible based on
different level of validation if resource is an issue– Consider CROs
• Follow up with MA/medical writer• Review and Comment • QC
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IDEAL FLOW OF MA’S REQUESTS
Requests from MA via SARF
Clinically and Clinically and statistically
sound?
Meetings with
Clinical/MA
y
Performing statistical analyses
No
Yes
Statistical results to
MWDrafts
BiostatsReview and QC
Final
Publish
Meetings
Clinical/MA
Meetings with
Clinical/MA
Adjustments or more analyses
All good
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HOW TO ACHIEVE THE BEST OUTCOME?
• The bottom line is– Send SARFs to biostats as early as possible – Communications and discussions are essential– Review and biostats QC
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BIOSTATISTICS PRIMER
Meg Franklin, PharmD, PhDFranklin Pharmaceutical Consulting
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INTRODUCTION
• Why are we here?• What should we get out of this?
Focus on: 1. Nomenclature2.What to report3. Common pitfalls
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• Categories of Studies
• Example Study DesignsStudy Design
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STUDY DESIGN
• 2 broad categories
Study Designs
Experimental Observational
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AUDIENCE QUESTION
AUDIENCE QUESTION
Which category of study design do you encounter most often in your work?
A. ExperimentalB. ObservationalC. Equal proportion of experimental and observationalD. NeitherE. I strive to avoid studies
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STUDY DESIGN
• Experimental study designs– Parallel– Cross-over– Factorial
Basic & Clinical Biostatistics (4th Ed). 38
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STUDY DESIGN
• Observational study designs
Cross-sectional
Case-Control CohortToday
Historical Control
Cross-sectional
Case-Control CohortToday
Historical Control
Adapted from Figure 2-5 in Basic & Clinical Biostatistics (4th Ed) 39
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STUDY DESIGN
• Observational study designs
Study Design Definition Common usesCross-sectional Reports data on a group of subjects at one time
rather than over a period of timeDescribes what is happening right now; hypothesis generating
Case-control Begin with the absence or presence of an outcome and then look backward in time to try to detect possible causes or risk factors
What happened?
Cohort Begins with the exposure and looks forward longitudinally for the outcome
What will happen?
Cross-sectional
Case-Control CohortToday
Historical Control
Cross-sectional
Case-Control CohortToday
Historical Control
40Basic & Clinical Biostatistics (4th Ed).
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STUDY DESIGN
• Observational study designsCross-
sectional
Case-Control CohortToday
Historical Control
Cross-sectional
Case-Control CohortToday
Historical Control
41Basic & Clinical Biostatistics (4th Ed).
StudyDesign Population size Longitudinal Direction of
observation Comparison Group
Cross-sectional Big No One point in time No
Case-control Big Yes Retrospective Yes
Cohort Big Yes Prospective Usually
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• Types of Analyses
• Metrics to ReportAnalyses
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ANALYSES
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• Unadjusted
• Adjusted– Regression– Cox Proportional Hazards Models
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ANALYSES (CONT.)
• Commonly reported metrics
P values and CIs
If possible, report both
Confidence intervals tell you everything you need to know
• Significance
• Idea of the range
RR and ORs
When are they alike?
Risk vs Odds
Significance
NNT/NNH
Resonate with clinicians
Dichotomous data required
Clinical significance vs statistical significance
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ANALYSES (CONT.)
• Quick Reference FormulasDisease(cases)
No Disease(control)
Risk factor present (treatment) A B A + B
Risk factor absent(no treatment) C D C + D
A + C B + D
Experimental event rate (EER) = A / (A + B)
Control event rate (CER) = C/(C + D)
Absolute risk reduction (ARR) = |EER – CER|
Number needed to treat (NNT) = 1/ARR
Relative risk reduction (RRR) = |EER-CER|= ARRCER CER
Relative risk (RR) = EER= [A/(A+B)]CER [C/(C+D)]
Odds ratio (OR) = (A/(A+C)/[C/(A+C)] =A/C =AD[B/(B+D)]/[D/(B+D)] B/D BC
45Basic & Clinical Biostatistics (4th Ed).
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ANALYSES (CONT.)
Common Pitfalls• Terminology
– Efficacy vs effectiveness• Significance based on Cis
– Crossing 0 or 1 (depending on measurement)• When metrics can be calculated
– Type of data– Significance
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AUDIENCE QUESTION
AUDIENCE QUESTION
Are there other types of categories/studies that you would be interested in learning more about?
A. Cost-effectiveness AnalysesB. Economic ModelsC. Decision AnalysisD. Randomized Control TrialsE. Patient Reported Outcomes
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• Publications
• CE and WorkshopsHelpful Resources
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RESOURCES
• Rascati, Karen L. Essentials of Pharmacoeconomics. Philadelphia: Lippincott Williams & Wilkins, 2009. Print.
• Dawson B, Trapp RG. Basic and Clinical Biostatistics 4th edition: Lange Medical book/McGraw Hill, 2004. Print. (ISBN 0-07-141017-1)
• http://www.pharmacy.arizona.edu/centers/hope/training-programs
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RESOURCES (CONT.)
• Motulsky, Harvey. Intuitive Biostatistics: A Nonmathematical Guide to Statistical Thinking, 3rd edition. New York: Oxford University Press, 2003. Print. (ISBN 9780199946648)
• Lang, Thomas A. How to Report Statistics in Medicine: Annotated Guidelines for Authors, Editors, and Reviewers, 2nd edition. USA: American College of Physicians, 2006. Print.
• Altman, Douglas. Practical Statistics for Medical Research. Chapman and Hall/CRC, 1990. Print.
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THANK YOU!
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• To ask a question, please type your query into the Q&A box• To ensure anonymity, before sending please choose the drop-
down box option, “ALL PANELISTS." Otherwise, ALLaudience members will be able to see your submitted question
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QUESTIONS . . .
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UPCOMING ISMPP U'S
• December 2015• Topic: Medical Devices
• January 2016• Topic: Manuscript Development
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THANK YOU FOR ATTENDING!
• We hope you enjoyed today's presentation. Please take a few moments to complete the survey that will appear on your screen immediately after the presentation. We depend on your valuable feedback and take it into account as we develop future educational offerings
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