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DTSTART:20231002T030000
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BEGIN:VEVENT
DESCRIPTION:\n\n\nPatient reported outcomes have become increasingly import
ant in the development\, approval and reimbursement of our products. The P
SI Scientific Committee have put together this one day meeting to provide
statisticians with introductions to PROs\, how to include them in clinical
trials\, considerations about missing data\, appropriate statistical meth
ods to analyse and interpret the data and the perspective of an IQWiG asse
ssor. Presenters will give their insight into discussions with colleagues\
, working groups and regulators and there will be plenty of opportunity to
ask any questions you may have about PROs in your development program.\n\
n\n\n \n \n Time \;\n  \;Topic\n
\n \n  \;9:00 &ndash\; 9:30\n Regis
tration\n \n \n  \; \;9:30 &ndash\; 9:45\
n  \;Welcome and Introduction to PSI and ISOQoL\n \n
\n  \;9:45 &ndash\; 10:30\n Introduction
to Patient Reported Outcome (PRO) Measurement\n Tara Symonds (
Clinical Outcome Solutions)\n \n \n \n
 \;10:30 &ndash\; 10:45  \;  \; \;\n Break\n
\n \n  \;10:45 &ndash\; 11:30\n Imp
roving the design and reporting of PRO trial data: implementation of the S
PIRIT-PRO and CONSORT-PRO Extensions\n Melanie Calvert (Birming
ham University)\n \n \n \n  \;11:3
0 &ndash\; 12:15\n Analysis of PROs in Oncology: A Perspective
from Industry\n Ingolf Griebsch (Boehringer-Ingelheim)\n
\n \n \n  \;12:15 &ndash\; 13:15\n
Lunch\n \n \n  \;13:15 &ndash\; 14:00\n
Analysis of PRO data: SISAQOL recommendations and practical ex
amples\n Kim Cocks (Adelphi Values)\n \n \n
\n  \;14:00 &ndash\; 14:45\n The Analysis
&\; Interpretation of Patient Reported Outcomes (PROs)\n Hel
en Doll (Clinical Outcome Solutions)\n \n \n \n
 \;14:45 &ndash\; 15:00\n  \;Break\n \
n \n  \;15:00 &ndash\; 15:30\n A perspect
ive from IQWiG when assessing treatment effects with PROs\n Chr
istoph Schü\;rmann (IQWiG)\n \n \n \n
 \;15:30 &ndash\; 16:00\n  \;Q&\;A\n
Christoph Schü\;rmann (IQWiG)\n Helen Doll (Clinical Outcom
e Solutions)\n Kim Cocks (Adelphi Values)\n Melanie
Calvert (Birmingham University)\n Ingolf Griebsch (Boehringer-I
ngelheim)\n Tara Symonds (Clinical Outcome Solutions)\n
\n \n \n  \;16:00\n Close\n
\n \n\n \;\nRegistration\n\n\n \n \n &nbs
p\;\n  \;Registration Fee\n \n \n
PSI Member \;\n £\;40+VAT \;\n \n \n
Non-Member\n £\;135+VAT (price includes PSI me
mbership for the year) \n \n \n\n\nPlease click here to register
.\n\n \n \n \n \n \n \n\nPlease click he
re to download the flyer. \;\n\n\n \n \n  \;\
n \n Tara Symonds (Clinical Outcome Solutions)  
\;  \;  \;  \;  \;  \;  \;  \;  \;  \;
 \;  \;  \;  \;  \;  \;  \;  \;  \; &
nbsp\;  \;  \;  \;  \;  \;  \;  \;  \; &nb
sp\;  \;  \;  \;  \;  \;  \;  \;  \;  
\;  \;  \;  \;  \;  \;  \;  \;  \;  \;
 \;  \;  \;  \;  \;  \;  \;  \;  \; &
nbsp\;  \;  \;  \;  \;  \;  \;  \;  \; &nb
sp\;  \;  \;  \;  \;  \;  \;  \;  \;  
\;  \;  \;  \;  \;  \;  \;  \;  \;  \;
 \;  \;  \;  \;  \;  \;  \;  \;  \; &
nbsp\;\n \n Introduction to Patient Reported Outcome
(PRO) Measurement\n  \;\n Abstract: This introd
uction to PRO measurement will initially cover what a PRO measure is and i
s not\, its history and importance in drug development from various stakeh
older perspectives (patient\, clinician\, payer and regulator). \; The
latter half of the presentation will concentrate on PRO development and v
alidation. \; The presentation will outline the basic psychometric pro
perties to investigate to demonstrate a measure is reliable\, valid\, and
sensitive-to-change. \; An overview of deriving a meaningful change th
reshold using an anchor-based approach will also be discussed.\n
 \;\n Biography: Tara Symonds is Strategic Lead at Clinic
al Outcomes Solutions providing advice on Clinical Outcome Assessments (CO
A) strategy from development to dissemination. \; Tara has 25+ years o
f experience in the COA field both negotiating labelling and in disseminat
ing results effectively with payers. \; She has worked in numerous the
rapeutic areas with extensive expertise in Sexual Health\, Women&rsquo\;s
Health\, Pain\, and Rare Diseases. \; She worked in industry for 16 ye
ars\, prior to this she worked in academia teaching undergraduate &\; p
ostgraduate psychology. \; She has published 80+ peer reviewed article
s and co-authored the book: Cappelleri et al (2014) Patient Reported Outco
mes: \; Measurement\, Implementation and Interpretation\, CRC Press.&n
bsp\; Tara holds a Doctorate in Health Psychology from the University of H
uddersfield\, UK.\n \n \n \n  \;\n
\n Melanie Calvert (Birmingham University)  \;
 \;  \;  \;  \;  \;  \;  \;  \;  \; &n
bsp\;  \;  \;  \;  \;  \;  \;  \;  \; &nbs
p\;  \;  \; \;\n \n \n \
n \n \n I
mproving the design and reporting of PRO trial data: implementation of the
SPIRIT-PRO and CONSORT-PRO Extensions\n Abstract:
Patient-reported outcome (PRO) results from clinical trials can provide va
luable evidence to inform clinical decision making\, pharmaceutical labell
ing claims and health policy. Despite this\, reviews of PRO protocol conte
nt and trial reporting demonstrate that the quality of PRO components rema
ins highly variable. The aim of this presentation is to highlight current
challenges in trial design and reporting\, share examples of good practice
\, and discuss approaches to implementation and uptake of SPIRIT-PRO and C
ONSORT-PRO guidance.\n Biography: Professor Melanie
Calvert\, PhD\, is Professor of Outcomes Methodology at the University of
Birmingham UK. She is Director of the Centre for Patient Reported Outcome
s Research (www.birmingham.ac.uk/cpror) which aims to optimize the use of
PROs in clinical trials and routine care\, to improve service delivery\, e
nhance patient care and outcomes and ensure that the patient perspective i
s at the heart of health research and healthcare decision-making. She is t
he cross-cutting theme lead for PROs research within National Institute fo
r Health Research infrastructure including the Biomedical Research Centre
Birmingham\, Surgical Reconstruction and Microbiology Research Centre and
MedTech Co-operative and is a member of the National Research Ethics Advis
ory Panel. After serving on the International Society for Quality of Life
Research (ISOQOL) Board of Directors she currently Chairs the ISOQOL Stand
ards and Best Practice and Committee and is a member of the Best Practice
for PROs in Clinical Trials Task force. She has >\;150 peer reviewed pub
lications in journals including the NEJM\, BMJ\, JAMA and the Lancet inclu
ding: the SPIRIT-PRO Extension (JAMA. 2018\; 319(5):483-494) CONSORT-PRO (
JAMA. 2013\; 309(8):814-822) PRO-Alerts (JAMA. 2013\; 310(12):1229-1230) a
nd pathways to impact for medical research (PLoS Med. 2017 Aug 9\;14(8):e1
002370). Her highly cited work has informed European Society of Cardiology
guidelines\, NICE and EMA guidance. Prof Calvert works closely with a wid
e range of national and international collaborators to maximise the reach\
, influence and impact of her research. She sits on a number of internatio
nal committees leading national and international strategy for PROs resear
ch/implementation including collaborative research with the EORTC led SISA
QOL initiative.\n \n \n
\n \n \n \n \n \n
 \;Ingolf Griebsch (Boehringer-Ingelheim)\n  \
;\n \n \n \n
\n Analysis of PROs in Oncology: A Perspecti
ve from Industry\n  \;\n
Abstract: In my talk\, I will discuss the current methodology available t
o devise PRO data collection strategies and the analytical approaches used
to analyse these data in Oncology clinical studies. I will also briefly d
iscuss different evidentiary standards employed by regulatory and health t
echnology assessment agencies to evaluate these data and highlight the nee
d to derive consensus recommendation for the analysis of these data in Onc
ology to increasingly use these data in decision making.\n
 \;\n Biography: Study of pharmacy\, pu
blic health and health economics. Work as research associate at the MRC HS
RC\, based at the Department of Social Medicine\, University of Bristol. f
rom 2001 to 2005. PhD in health economics from the University in Bristol i
n 2009. Move to the pharmaceutical industry in 2005. Since 2012\, I have b
een leading the Global market access team for Oncology at Boehringer Ingel
heim. Lead of the industry consortium for the IMI 2 application (Call 18)
&ldquo\;Establishing international standards in the analysis of patient re
ported outcomes and health-related quality of life data in cancer clinical
trials&rdquo\;.\n  \;\n
\n \n \n \n \n
\n \n \n  \;\n \n
Kim Cocks (Adelphi Values)\n \n SISAQoL guidance
&\; analysis methods for missing data\n Abstract: This sess
ion will cover two topics\, firstly an overview of new guidelines aimed at
standardizing the analysis of PROs in oncology clinical trials and\, seco
ndly\, presenting some practical examples of longitudinal analyses dealing
with informative missing data.\n Biography: D r Kim Cocks is a
Director in the Patient-Centered Outcomes team at Adelphi Values\, headin
g up their statistics and programming team in the UK. Kim has over 20 year
s&rsquo\; experience as a medical statistician working in clinical trials
and associated methodological research. She has worked across pharmaceutic
al\, medical device\, academia and consultancy companies.\n Kim
is a Board member for ISOQOL (International Society for Quality of Life R
esearch) and part of an international consortium seeking to standardise th
e analysis of patient reported outcome data in oncology trials (SISAQOL).
\n \n \n \n  \;\n \n
Helen Doll (Clinical Outcome Solutions)\n The Analysis
&\; Interpretation of Patient Reported Outcomes (PROs) \;\n
\n Abstract: This session on the analysis and interpretati
on of PROs will introduce the main types of statistical analyses that can
be applied to the analysis of PRO data and to flag the main issues that sh
ould be considered in these analyses\, such as multiplicity of endpoints\,
repeated assessment timepoints\, between-group or within-subject analysis
\, and treatment of missing data. Further discussion of assessment and app
lication of existing thresholds for evaluating meaningful change\, such as
the use of PDFs and CDFs\, and detailed tabular representation of outcome
by anchor status\, will also be included. The need to ensure that suffici
ent analyses for the relevant stakeholders are captured in the clinical tr
ial/additional HTA SAP will also be covered\, so that these analyses\, and
their interpretation\, take account of local and regional review needs to
support HTA submissions.\n Biography: Helen Doll is the Strate
gic Lead of Quantitative Sciences at Clinical Outcomes Solutions. Helen is
a Medical Statistician and Psychometrician who has completed over 25 year
s of clinical research experience\, both in academia and in the pharmaceut
ical industry. Prior to joining COS in the February of 2018\, Helen had le
d the quantitative team within ICON&rsquo\;s Patient Centred Outcomes grou
p for more than five years. She has also held Senior Medical Statistician
and Lecturer positions at the Universities of Oxford and East Anglia. Hele
n has co-authored more than 130 peer-reviewed papers\, is a Fellow of the
Royal Statistical Society\, and provides statistical reviews for journals
such as the British Medical Journal and Quality of Life Research. Helen ho
lds a BSc in Biological Sciences from the University of Warwick\, and a Di
ploma in Applied Statistics\, MSc and a DPhil in Medical Statistics from t
he University of Oxford.\n \n \n \n &n
bsp\;\n Christoph Schü\;rmann (IQWiG)\n \n
A perspective from IQWiG when assessing treatment effects with PROs\
n  \;\n Abstract: Assessing patient reported out
comes is part of the (added) benefit assessment of medical interventions.
PROs usually are considered to analyse aspects of morbidity and health-rel
ated quality of life. For valid conclusions on PRO assessments\, suitable
and validated instruments are required. This talk gives an overview on PRO
assessment criteria applied by IQWiG and commonly experienced challenges
when interpreting aggregate data. In this context relevant matters are pre
-planned periods of evaluation and cut-off choices along with strategies f
or handling missing data. Some examples from past assessments are presente
d to illustrate these issues and their impact on the final assessment.&nbs
p\;\n \n Biography: Christoph Schü\;rmann gradua
ted from the University of Dortmund with a diploma \;in Statistics in
2002 and with a doctoral degree in 20018. He's been a research associate a
t the department of Medical Biometry at the Institute \;for Quality an
d Efficiency in Health Care (IQWiG) since 20019. His research interests ar
e systematic reviews\, meta-analysis\, network meta-analysis\, surrogate e
ndpoint validation and health-related quality of life assessments. \;\
n \n \n \n  \;All presenters\n
 \;Q &\; A Session\n \n \n\n\n\n\n \n \
n \n \n \n \n \n \n \n
\n\n
DTEND:20190717T143000Z
DTSTAMP:20240329T100056Z
DTSTART:20190717T073000Z
LOCATION:
SEQUENCE:0
SUMMARY:PSI One day Scientific meeting: The analysis and reporting of PROs
in Clinical Trials
UID:RFCALITEM638473032561900897
X-ALT-DESC;FMTTYPE=text/html:
\n
\n
\nPatient reported outcomes have become increasingly
important in the development\, approval and reimbursement of our products
. The PSI Scientific Committee have put together this one day meeting to p
rovide statisticians with introductions to PROs\, how to include them in c
linical trials\, considerations about missing data\, appropriate statistic
al methods to analyse and interpret the data and the perspective of an IQW
iG assessor. Presenters will give their insight into discussions with coll
eagues\, working groups and regulators and there will be plenty of opportu
nity to ask any questions you may have about PROs in your development prog
ram.\n
\n
\n
Time \; | \n \;T opic | \n
 \; 9:00 &ndash\; 9:30 | \nRegistration | \n
&nb sp\; \;9:30 &ndash\; 9:45 | \n \;Welcome and Introduction to PSI and ISOQoL | \n
 \;9:45 &ndash\; 10:30\n | Introduction to
Patient Reported Outcome (PRO) Measurement\n Tara Symond s (Clinical Outcome Solutions) \n | \n
 \;10:30 &ndash\; 10:45  \; &nbs p\; \; | \nBre ak | \n
 \;10:45 &ndas h\; 11:30 | \nImpr
oving the design and reporting of PRO trial data: implementation of the SP
IRIT-PRO and CONSORT-PRO Extensions\n Melanie Calvert (B irmingham University) \n | \n
 \;11:30 &ndash\; 12:15 | \nAnalysis of PROs in Oncology: A Pers
pective from Industry\n Ingolf Griebsch (Boehringer-Inge lheim) \n | \n
 \;12:15 &ndash\; 13:15 | \nLunch | \n
 \;13:15 &ndash\; 14:00 | \nAnalysis of PRO data: SISAQOL recommendations and p
ractical examples\n Kim Cocks (Adelphi Values) \ n | \n
 \; 14:00 &ndash\; 14:45 | \nThe Analysis &\; Interpretation of Patient Reported Outcomes (PR
Os)\n Helen Doll (Clinical Outcome Solutions) \n | \n
 \; 14:45 &ndash\; 15:00 | \n \;Break | \n
& nbsp\;15:00 &ndash\; 15:30 | \nA perspective from IQWiG when assessing treatment effects wit
h PROs\n Christoph Schü\;rmann (IQWiG) \n | \n
 \;15:3 0 &ndash\; 16:00 | \n \;Q&\;A\n Christoph Schü\;rmann (IQWiG)\n Helen Doll (Clinical
Outcome Solutions) | \n
 \;16:00 | \nClose | \n
 \;
\
nRegistration
\n
 \; | \n \;Registra tion Fee | \n
PSI Member&n bsp\; | \n£\; 40+VAT \; | \n
Non-Me mber | \n£\;1 35+VAT (price includes PSI membership for the year) | \n
\nPle
ase click here to register.
 \; \n \n Tara Symonds (Clinic al Outcome Solutions)  \;  \;  \;  \;  \;  \; &nbs p\;  \;  \;  \;  \;  \;  \;  \;  \;  \ ;  \;  \;  \;  \;  \;  \;  \;  \;  \;  \;  \;  \;  \;  \;  \;  \;  \;  \; &n bsp\;  \;  \;  \;  \;  \;  \;  \;  \; &nbs p\;  \;  \;  \;  \;  \;  \;  \;  \;  \ ;  \;  \;  \;  \;  \;  \;  \;  \;  \;  \;  \;  \;  \;  \;  \;  \;  \;  \; &n bsp\;  \;  \;  \;  \;  \;  \;  \;  \; &nbs p\;  \;  \;  \;  \;  \;  \;  \;  \;  \ ;  \;  \;  \;  \; | \n \n < strong>Introduction to Patient Reported Outcome (PRO) Measurement \n \; \nAbstract: This introduction to PRO measurement will initially cov er what a PRO measure is and is not\, its history and importance in drug d evelopment from various stakeholder perspectives (patient\, clinician\, pa yer and regulator). \; The latter half of the presentation will concen trate on PRO development and validation. \; The presentation will outl ine the basic psychometric properties to investigate to demonstrate a meas ure is reliable\, valid\, and sensitive-to-change. \; An overview of d eriving a meaningful change threshold using an anchor-based approach will also be discussed. \n \; \nBiography: Tara Symonds is Strategic Lead at Clinical Outcomes S olutions providing advice on Clinical Outcome Assessments (COA) strategy f rom development to dissemination. \; Tara has 25+ years of experience in the COA field both negotiating labelling and in disseminating results e ffectively with payers. \; She has worked in numerous therapeutic area s with extensive expertise in Sexual Health\, Women&rsquo\;s Health\, Pain \, and Rare Diseases. \; She worked in industry for 16 years\, prior t o this she worked in academia teaching undergraduate &\; postgraduate p sychology. \; She has published 80+ peer reviewed articles and co-auth ored the book: Cappelleri et al (2014) Patient Reported Outcomes: \; M easurement\, Implementation and Interpretation\, CRC Press. \; Tara ho lds a Doctorate in Health Psychology from the University of Huddersfield\, UK. \n | \n |
 \; \n \n Melanie Calvert (Birmingha m University)  \;  \;  \;  \;  \;  \;  \; &nbs p\;  \;  \;  \;  \;  \;  \;  \;  \;  \ ;  \;  \;  \;  \;  \; \; | \n
| \n |
&nbs p\;Ingolf Griebsch (Boehringer-Ingelheim) | \n \;\n
\n | \n |
 \; \n \n Kim Cocks ( Adelphi Values) | \n \n SISAQoL gui dance &\; analysis methods for missing data \n < p>Abstract: This session will cover two topics\, firstly an overview of new guidelines aimed at standardizing the analysis of PROs in oncology clinical trials and\, secondly\, presenting some practical exa mples of longitudinal analyses dealing with informative missing data.\ nBiography: D r Kim Cocks is a Director in the Patient-Centered Outcomes team at Adelphi Values\, heading up their s tatistics and programming team in the UK. Kim has over 20 years&rsquo\; ex perience as a medical statistician working in clinical trials and associat ed methodological research. She has worked across pharmaceutical\, medical device\, academia and consultancy companies. \nKim is a Board member for ISOQOL (International Society for Quality of Life Resear ch) and part of an international consortium seeking to standardise the ana lysis of patient reported outcome data in oncology trials (SISAQOL). \ n | \n |
 \; \n \n H elen Doll (Clinical Outcome Solutions) | \n The A
nalysis &\; Interpretation of Patient Reported Outcomes (PROs)
 \; \n \n Abstract: This session on the analysis and interpretation of PROs will introduce
the main types of statistical analyses that can be applied to the analysis
of PRO data and to flag the main issues that should be considered in thes
e analyses\, such as multiplicity of endpoints\, repeated assessment timep
oints\, between-group or within-subject analysis\, and treatment of missin
g data. Further discussion of assessment and application of existing thres
holds for evaluating meaningful change\, such as the use of PDFs and CDFs\
, and detailed tabular representation of outcome by anchor status\, will a
lso be included. The need to ensure that sufficient analyses for the relev
ant stakeholders are captured in the clinical trial/additional HTA SAP wil
l also be covered\, so that these analyses\, and their interpretation\, ta
ke account of local and regional review needs to support HTA submissions.<
/p>\n Biography: Helen Doll is the Strategi
c Lead of Quantitative Sciences at Clinical Outcomes Solutions. Helen is a
Medical Statistician and Psychometrician who has completed over 25 years
of clinical research experience\, both in academia and in the pharmaceutic
al industry. Prior to joining COS in the February of 2018\, Helen had led
the quantitative team within ICON&rsquo\;s Patient Centred Outcomes group
for more than five years. She has also held Senior Medical Statistician an
d Lecturer positions at the Universities of Oxford and East Anglia. Helen
has co-authored more than 130 peer-reviewed papers\, is a Fellow of the Ro
yal Statistical Society\, and provides statistical reviews for journals su
ch as the British Medical Journal and Quality of Life Research. Helen hold
s a BSc in Biological Sciences from the University of Warwick\, and a Dipl
oma in Applied Statistics\, MSc and a DPhil in Medical Statistics from the
University of Oxford. | \n |
 \; \n Christoph Schü\; rmann (IQWiG) \n | \n A perspectiv
e from IQWiG when assessing treatment effects with PROs\n
 \; \n Abstract: Assessing patie nt reported outcomes is part of the (added) benefit assessment of medical interventions. PROs usually are considered to analyse aspects of morbidity and health-related quality of life. For valid conclusions on PRO assessme nts\, suitable and validated instruments are required. This talk gives an overview on PRO assessment criteria applied by IQWiG and commonly experien ced challenges when interpreting aggregate data. In this context relevant matters are pre-planned periods of evaluation and cut-off choices along wi th strategies for handling missing data. Some examples from past assessmen ts are presented to illustrate these issues and their impact on the final assessment. \;\n \n Biograph y: Christoph Schü\;rmann graduated from the University of Dor tmund with a diploma \;in Statistics in 2002 and with a doctoral degre e in 20018. He's been a research associate at the department of Medical Bi ometry at the Institute \;for Quality and Efficiency in Health Care (I QWiG) since 20019. His research interests are systematic reviews\, meta-an alysis\, network meta-analysis\, surrogate endpoint validation and health- related quality of life assessments. \; \n | \n
|
 \;All presenters | \n \;Q &\; A Session | \n