The document summarizes the rationale for transforming a big pharmaceutical company's global clinical trials footprint. It discusses:
1) Increasing drug development costs and the need for more trials and patients to get approvals, driving the need for changes.
2) An analysis of baseline clinical trials data across many countries that found cycle times exceeding benchmarks and inhibiting bringing drugs to market faster.
3) A process for selecting core and non-core countries for clinical trials based on quality, population size, performance metrics, and a quantitative and qualitative analysis.
4) The resulting new clinical trials footprint, designating some European, Asian, and other countries and regions as core, with others as non-core.
Slides from the presentation on extrapolation from progression free survival to overall survival in oncology given at the 2017 HTAi Annual Meeting in Rome
Slides from the presentation on extrapolation from progression free survival to overall survival in oncology given at the 2017 HTAi Annual Meeting in Rome
Point of Care Testing for Enhancing Patient Centered Planned Care DeliveryPAFP
PAFP 2013 Regional Lecture Series
Session 1 - Northeast
Presenter: Linda Thomas-Hemak, MD
The Wright Center for Primary Care
Broadcast live through the PAFP Community.
October 2nd, 2013 12pm - 1pm
Globalization of Clinical Trials: Mutual acceptance of Medical Device dataAnnet Visscher
Technologies and regulatory standards facilitate clinical trial globalization and mutual acceptance of clinical trial data. Changes in trial execution, however, are not 1:1 reflected in foreign data acceptance. Factors such as ethnic and local requirements seem to outweigh the benefits.
There are many areas to focus on when taking steps towards improving clinical trial operations. This presentation focuses on 4 areas: Patient Enrollment, Study Start-up, Monitoring, and Project Management.
Keynote Presentation "Meaningful Use Stage 2 and Meaningful Use Audit Insight"
Think far beyond just threshold increases. The differences between Meaningful Use (MU) Stage 1 and Stage 2, including the 2014 Clinical Quality Measures, are technically and clinically challenging. And just when you thought you could safely look at Stage 1 in the rearview mirror, here come the audits! I will highlight the Stage 1 and Stage 2 differences and talk about the challenges they have initiated at Tenet. I will touch on the impact of Quality measures and will also provide you with insight into the basics of MU Audits and will take you through the actual audit experience at Tenet.
Learning Objectives:
∙ Review the program and measure changes from Stage 1 to Stage 2 and how the changes are being managed at Tenet
∙ Provide insight into the 2014 Clinical Quality Measures chosen by Tenet, the challenges posed, solutions that work and a little about the overall
impact of Quality measures
∙ Discuss Meaningful Use Audits, covering the basics as well as providing the benefit of the Tenet experience
Point of Care Testing for Enhancing Patient Centered Planned Care DeliveryPAFP
PAFP 2013 Regional Lecture Series
Session 1 - Northeast
Presenter: Linda Thomas-Hemak, MD
The Wright Center for Primary Care
Broadcast live through the PAFP Community.
October 2nd, 2013 12pm - 1pm
Globalization of Clinical Trials: Mutual acceptance of Medical Device dataAnnet Visscher
Technologies and regulatory standards facilitate clinical trial globalization and mutual acceptance of clinical trial data. Changes in trial execution, however, are not 1:1 reflected in foreign data acceptance. Factors such as ethnic and local requirements seem to outweigh the benefits.
There are many areas to focus on when taking steps towards improving clinical trial operations. This presentation focuses on 4 areas: Patient Enrollment, Study Start-up, Monitoring, and Project Management.
Keynote Presentation "Meaningful Use Stage 2 and Meaningful Use Audit Insight"
Think far beyond just threshold increases. The differences between Meaningful Use (MU) Stage 1 and Stage 2, including the 2014 Clinical Quality Measures, are technically and clinically challenging. And just when you thought you could safely look at Stage 1 in the rearview mirror, here come the audits! I will highlight the Stage 1 and Stage 2 differences and talk about the challenges they have initiated at Tenet. I will touch on the impact of Quality measures and will also provide you with insight into the basics of MU Audits and will take you through the actual audit experience at Tenet.
Learning Objectives:
∙ Review the program and measure changes from Stage 1 to Stage 2 and how the changes are being managed at Tenet
∙ Provide insight into the 2014 Clinical Quality Measures chosen by Tenet, the challenges posed, solutions that work and a little about the overall
impact of Quality measures
∙ Discuss Meaningful Use Audits, covering the basics as well as providing the benefit of the Tenet experience
The Use of EDC in Canadian Clinical TrialsKhaled El Emam
Presentation at CHEO Research Rounds on a study to estimate the proportion of Canadian clinical trials that are using an Electronic Data Capture system during the period 2006-2007.
“CSR is a detailed regulatory document which gives the information about the methods and results (related to efficacy and safety) of a clinical trial. CSRs are created as a part of the process of submitting applications to the Regulatory Authorities for new medical treatments and for its approval. CSRs can be full, abbreviated, synopsis, supplementary, observational etc as per the results and requirements”.
IMS Health Clinical Trial Optimization SolutionsQuintilesIMS
IMS Health's Linda T. Drumright, general manager, Clinical Trial Optimization Solutions presents at the 3rd Annual Patient Recruitment & Retention Summit 2014 - San Francisco, CA
This is a study case in all the photosthe SIPOC diagram bel.pdfjkcs20004
This is a study case in all the photos
the SIPOC diagram bellow is incomplete and wrong I need to fix it
Perfect Match TEAM APPLIES n January 2008, the University of Toledo Medical Center
(UTMC) in northwest Ohio collaborated with the University of Toledo's Industrial SIX SIGMA
TO Engineering Department to analyze and improve the preoperational processes for patients
undergoing kidney transplants. Six Sigma was applied to the REDUCE TIME project, and the
following goals were established: IT TAKES TO - Optimize cycle times. QUALIFY PATIENTS
- Enhance customer satisfaction. - Improve efficiencies. FOR KIDNEY - Reduce costs.
TRANSPLANTS - Streamline administrative processes. - Eliminate errors. - Improve protocol
execution and effectiveness. The project's primary metric was the number of days required from
the date a patient was referred to UTMC for a kidney transplant to the date the hospital staff
declared the patient a suitable transplant candidate. The research By Matthew was needed and
the project selected because of an increase in the number of Franchetti and year because of the
increased service area for UTMC. Because of a waiting list of nearly 500 patients, it was
determined a reduced cycle time would save lives. Kyle Bedal, Background and terminology
University of For more than 30 years, UTMC has performed adult and pediatric kidney Toledo
transplants as one of the treatment options for end-stage renal disease. Since UTMC's first
kidney transplant operation in 1972, more than 1,500 kidney transplant operations have been
performed there, with an average patient survival rate of 98% and a graft survival rate of 94%.
The program relies on advanced surgical techniques-including laparoscopic kidney donation,
improved anti-rejection medications and high-quality patient care-to make it one of the most
successful programs in the country. There are a number of steps patients must complete before
receiving a kidney transplant. Generally, the patient must be referred to a medical center and
complete required labs and tests to determine if he or she is suitable. The labs and tests are
usually similar among all transplant centers and among patients. The labs include tuberculosis
(TB) tests, dental clearance, a colonoscopy, chest X-rays, electrocardiography tests, stool
samples, blood work, mammograms, pap smears and diabetes tests. Once the patient fulfills the
requirements, a committee reviews the results and determines whether the patient is a good
candidate. The patient is then allowed to receive a kidney; this is called being "listed," or placed
on the waiting list.
Fil TB EK Often, the time required to complete these health Partnering With Your Transplant
Team, The Patient's Guide screenings is up to nine months. In addition, another to
Transplantation. 2 two years may pass after the patient is listed before a The team deployed the
define, measure, analyze, kidney transplant is performed. improve and control (DMAIC)
approach for this Six It is.
How to Submit Non-Clinical Data to CBER Using SEND : Understanding New FDA Re...MMS Holdings
What You Will Learn
The FDA’s CBER will begin requiring electronic submissions of nonclinical data to be submitted using the 3.1 and 3.1.1 versions of CDISC SENDIG on March 15th, 2023. With these requirements taking effect soon, Sponsors need to understand how to meet the new rules and regulations provided by SEND, as failing to meet them could result in FDA refusal.
In this webinar, a cross-functional team of statistical programmers and regulatory experts will share actionable insights to help study teams prepare for the new requirements.
Attendees will learn how to:
Understand nonclinical study data submissions to CDER and CBER
Differentiate biologics from drug submission in non-clinical studies
Prepare for this change to ensure a successful submission.
Solve the challenges of a SEND package
Ensure compliance with both SEND 3.1 and 3.1.1 for submission of nonclinical data to CDER and CBERHo
Separate SEND IG DART 1.1 from SEND IG
Manage legacy studies and studies that already meet requirements
Differentiate between submission packages
Use the FDA’s data standard catalog, technical conformance guide and controlled terminology
Who Will Benefit from Attending?
Regulatory Affairs and Submissions Professionals
Pharmaceutical Data and Programming Professionals
Nonclinical/Preclinical Development Professionals
The Relationship Between Quality of Care and Choice of Clinical Computing System: Retrospective Analysis of Family Practice Performance Under the UK Quality and Outcomes Framework
Derick Mitchell_Biobanking from the patient perspective.pdfipposi
IPPOSI CEO Derick Mitchell presented the patient perspective on biobanking at the 2023 WECAN Academy for Cancer Patient Advocates on July 2nd, 2023 in Frankfurt, Germany.
Mental Health - Leading the data sharing charge with a rights-based approachipposi
Frankie Prendergast's (Digital Health Applications Programme Manager in St Patrick's Mental Health Services) presentation on health information at the 2023 IPPOSI Conference.
Muiris O'Connor, Assistant Secretary of the Department of Health, presented key government updates on health information at the 2023 IPPOSI Conference Building a Data Sharing Health Sector in Ireland.
Clinical Workflow for Capture of Patient Registry Dataipposi
Clare Harney, Managing Director of HD Health, gave a lightning presentation on managing data for patient registries at the 2023 IPPOSI Conference on Building a Data Sharing Health Sector in Ireland.
EU Clinical Trials Regulation - IPPOSI perspectiveipposi
IPPOSI CEO, Dr Derick Mitchell delivered a presentation on the EU Clinical Trials Regulation from the patients' perspective at the 20th International Conference on Pharmaceutical Medicine, Athens, Greece.
Patient Centricity in Value-based healthcare, Sept 2022ipposi
IPPOSI CEO Derick Mitchell delivered a presentation as part of the RCSI Value Based Healthcare Webinar on Patient Centricity on Sept 18th, 2022.
The Future of Value Based Healthcare in Ireland webinar series is run by The RCSI Healthcare Outcomes Research Centre, Janssen Sciences Ireland UC and Novartis Ireland.
2022 World Day Brain Event - IPPOSI Presentationipposi
Laura Kavanagh, Research and Advocacy Manager in IPPOSI, gave a presentation on World Brain Day 2022 at an event hosted by the Neurological Alliance of Ireland.
In October 2020, IPPOSI published a membership engagement survey on its draft 4-year strategy. This slide deck captures the summary results of the survey.
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
263778731218 Abortion Clinic /Pills In Harare ,sisternakatoto
263778731218 Abortion Clinic /Pills In Harare ,ABORTION WOMEN’S CLINIC +27730423979 IN women clinic we believe that every woman should be able to make choices in her pregnancy. Our job is to provide compassionate care, safety,affordable and confidential services. That’s why we have won the trust from all generations of women all over the world. we use non surgical method(Abortion pills) to terminate…Dr.LISA +27730423979women Clinic is committed to providing the highest quality of obstetrical and gynecological care to women of all ages. Our dedicated staff aim to treat each patient and her health concerns with compassion and respect.Our dedicated group ABORTION WOMEN’S CLINIC +27730423979 IN women clinic we believe that every woman should be able to make choices in her pregnancy. Our job is to provide compassionate care, safety,affordable and confidential services. That’s why we have won the trust from all generations of women all over the world. we use non surgical method(Abortion pills) to terminate…Dr.LISA +27730423979women Clinic is committed to providing the highest quality of obstetrical and gynecological care to women of all ages. Our dedicated staff aim to treat each patient and her health concerns with compassion and respect.Our dedicated group of receptionists, nurses, and physicians have worked together as a teamof receptionists, nurses, and physicians have worked together as a team wwww.lisywomensclinic.co.za/
- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
- Video recording of this lecture in Arabic language: https://youtu.be/Ve4P0COk9OI
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
Pulmonary Thromboembolism - etilogy, types, medical- Surgical and nursing man...VarunMahajani
Disruption of blood supply to lung alveoli due to blockage of one or more pulmonary blood vessels is called as Pulmonary thromboembolism. In this presentation we will discuss its causes, types and its management in depth.
The prostate is an exocrine gland of the male mammalian reproductive system
It is a walnut-sized gland that forms part of the male reproductive system and is located in front of the rectum and just below the urinary bladder
Function is to store and secrete a clear, slightly alkaline fluid that constitutes 10-30% of the volume of the seminal fluid that along with the spermatozoa, constitutes semen
A healthy human prostate measures (4cm-vertical, by 3cm-horizontal, 2cm ant-post ).
It surrounds the urethra just below the urinary bladder. It has anterior, median, posterior and two lateral lobes
It’s work is regulated by androgens which are responsible for male sex characteristics
Generalised disease of the prostate due to hormonal derangement which leads to non malignant enlargement of the gland (increase in the number of epithelial cells and stromal tissue)to cause compression of the urethra leading to symptoms (LUTS
Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva.
Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais.
O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
Prof. Marcus Renato de Carvalho
www.agostodourado.com
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
Follow us on: Pinterest
Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
Prix Galien International 2024 Forum ProgramLevi Shapiro
June 20, 2024, Prix Galien International and Jerusalem Ethics Forum in ROME. Detailed agenda including panels:
- ADVANCES IN CARDIOLOGY: A NEW PARADIGM IS COMING
- WOMEN’S HEALTH: FERTILITY PRESERVATION
- WHAT’S NEW IN THE TREATMENT OF INFECTIOUS,
ONCOLOGICAL AND INFLAMMATORY SKIN DISEASES?
- ARTIFICIAL INTELLIGENCE AND ETHICS
- GENE THERAPY
- BEYOND BORDERS: GLOBAL INITIATIVES FOR DEMOCRATIZING LIFE SCIENCE TECHNOLOGIES AND PROMOTING ACCESS TO HEALTHCARE
- ETHICAL CHALLENGES IN LIFE SCIENCES
- Prix Galien International Awards Ceremony
Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
NYSORA Guideline
2 Case Reports of Gastric Ultrasound
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists
Damian o'connell - Transformation of the global clinical trials footprint in a big Pharma company - 2009
1. Case Study
Transformation of the global clinical trials
footprint in a big Pharma company
Key Learnings as to How International BioPharma views
Ireland
Damian O’Connell MD PhD BSc
VP Clinical Research
Pfizer
Company
logo here
1
2. 2 2
Overview
Rationale for change
Baseline status and end game vision
Country selection process
The new foot print
Why Ireland is Non-Core
Developing a Functioning Clinical Research System
3. 3 3
Rationale for change
Drug development costs are increasing dramatically
although output is flat or declining
It takes more trials and more patients per trial to get a
new drug application approved;
New approaches e.g. pharmacogenomics, and reduced
attrition is resulting in increased expenditure on
development operations activities
Study start up and subject recruitment are major challenges
Speed, Quality and Cost reduction are strategic imperatives
4. 4 4
Rationale for change:
Length of Protocols is Increasing
Length of Protocol incl. Appendix vs. Median
FAP-LSFV Cycle Time
Median Length of Protocol incl. Appendix Over
Time
• Median length of Pfizer protocols grew
18 pages
• This trend is not phase or TA
dependent
• Protocols longer than 100 pages have
FAP-LSFV cycle time medians 97% >
than with < 60 pages
• This is not driven by phase of study or
TA
MedianFAP-LSFVCycleTime
• (n=1, 9,
10)
Length of Final Protocol incl. Appendix in Pages
• (n=8,
11, 15)
• (n=6, 5,
10)
MedianLengthofFinalProtocolincl.Appendix
• (n=18)
LSFV Year
• (n=26) • (n=32)
* Source: Data manually extracted from 76 protocols that span all Phases and CVMED, GU, Neurology, Oncology, and Pain Therapeutic Areas
• (Phase
I, II, III)
5. 5 5
Rationale for Change:
Number of Eligibility Criteria is Increasing
Number of Eligibility Criteria vs. Median FAP-
LSFV Cycle Time
Median Number of Eligibility Criteria Over Time
• Median # of eligibility criteria (sum of
inc/exc) grew most b/w 2005 and 2006
• Trend is not phase or TA dependent
• # of eligibility criteria has some impact
on FAP-LSFV cycle times; most often
with >30 criteriaMedianFAP-LSFVCycleTime
• (n=3, 7,
4)
Number of Eligibility Criteria
• (n=3,
15, 6)
• (n=12,
10, 14)• (n=18)
LSFV Year
• (n=26) • (n=32)
MedianNumberofEligibilityCriteria
* Source: Data manually extracted from 76 protocols that span all Phases and CVMED, GU, Neurology, Oncology, and Pain Therapeutic Areas
• (Phase
I, II, III)
6. 6 6
Rationale for Change:
Number of Protocol Procedures is Increasing
Number of Procedures/Protocol vs. Median FAP-
LSFV Cycle Time
Number of Procedures/Protocol Over Time
• Number of procedures are increasing by year
• Trend consistent with industry data (Tufts
CSDD, Getz)
• Trend consistent across all phases and in the
Oncology and Pain TAs.
• Increase in the number of procedures
correlates with increase in cycle times;
especially if > 60 procedures
MedianFAP-LSFVCycleTime
• (n=3, 5,
3)
Number of Procedures/Protocol Criteria
• (n=1, 8,
10)
• (n=2, 3,
12)
* Source: Data manually extracted from 76 protocols that span all Phases and CVMED, GU, Neurology, Oncology, and Pain Therapeutic Areas
• (Phase
I, II, III)
MedianNumberProceduresperProtocol
LSFV Year
• (n=18) • (n=25) • (n=29)
20%
19%
11%
2%
24%
5%
9%
2%
1%
18%
2%
10%
3%
3%
52
41
35
7. 7 7
Rationale for Change:
Number of CRF Enterable Fields is Increasing
# of Enterable Fields Over Time
• Median # of enterable fields increased
by 103%
• Pfizer protocols require investigators
to collect more data per protocol
• Upward trend seen across all phases
and TAs
• Increase in the number of
enterable fields appears to
increase cycle times
# of Enterable Fields vs. Median FAP-LSFV Cycle
Time
• (n=15)
LSFV Year
• (n=20) • (n=31)
MedianNumberofEnterableFields
MedianFAP-LSFVCycleTime
• (n=2, 6,
10)
Number of Enterable Fields
• (n=2, 3,
6)
• (n=4, 4,
4)
• (n=1, 8,
5)
• (n=4, 4,
4)
* Source: Data manually extracted from 76 protocols that span all Phases and CVMED, GU, Neurology, Oncology, and Pain Therapeutic Areas
• (Phase
I, II, III)
8. 8 8
Baseline Country Clinical Trials
Footprint
Indicates country where an R&D based office is located
Indicates country where R&D studies are being conducted, but no office
62 Country Clinical Operations groups
20+ additional countries where clinical studies are performed
9. 9 9
Europe
Asia
Can/Africa/Middle
East
Study Distribution - September 2008
Canada
Protocols 88 22%
Patients 3871 4%
US
Protocols 308 78%
Patients 34599 32%
EU Non EM
Protocols 165 42%
Patients 26590 24%
LA/AFME
Protocols 83 21%
Patients 13386 12%
Global
Protocols 395
Patients 109256
Asia (excl. AU, KOR)
Protocols 43 11%
Patients 6776 6%
Korea
Protocols 50 13%
Patients 2573 2%
Australia
Protocols 53 13%
Patients 2155 2%
EU EM
Protocols 71 18%
Patients 19306 18%
10. 1010
Baseline Status
Pfizer patient recruitment cycle times (FAP to LSFV) exceed industry benchmarks and inhibit Pfizer’s
ability to quickly bring drugs to market
• Not in Scope: Phase 1 volunteer, Ph 3b/4 regional and country sponsored studies
• Baseline Data Set included: 273 protocols, 75 countries, 8313 total sites, 5666 unique sites, 89,587
patients across 11 therapeutic areas
465
441
Pfizer Actual - All patient
studies, all TAs, phases I, II, III
and globally sponsored IV, with
LSFV on or after 01-Jan-2005
Pfizer Targets – “Best in class”
cycle time
CMR Industry Benchmark -
Centre for Medicines Research
Global Clinical Programmed
Rpt v1.0 (May 2007)
FAP to FSFV
FSFV to LSFV
Cycle Time Performance 2005 – 2008*
Project and Data Analysis Scope * Calendar Days
11. 1111
Country Selection
• Recommendations from root cause analysis:
– ≥50% reduction in number of countries with Pfizer has infrastructure/staff
• Assumed a significant reduction in global clinical trial volume
• Assumed reduction in relative allocation of EU patient volume
• Anticipated shift of clinical trial placement to lower cost and/or high speed regions
(NB quality maintained)
• Classified country operations into core and non core countries
Definitions
Non
Core
• No interruption to ongoing, committed studies that will be
performed by Pfizer staff
• Attrition of staff until all commitments accomplished
• New studies (by exception) to be conducted by CROs in these
countries
Core
• No interruption to ongoing, committed studies
• Place studies actively and increase staff accordingly
12. 1212
12
Country Selection
Quality and
risk filter
1
Core
Non Core
All
countries
Countries with
high political
instability and/or
environ-mental
risk are excluded
Population is
defined as ages
15 – 65
Countries with
population ≤ 3M
are excluded
Performance-based metrics
include startup speed, cycle time
(regulatory to LSFV), subjects /
site, recruitment reliability, MBR*,
and subjects/ FTE**
Metrics were grouped into three
categories: high, medium, and
low
Population
filter
2
Evaluate
countries based
on performance
metrics
3 Prioritize based on
quantitative and qualitative
analysis
4
*Monitor Burden rate
** FTEs include both permanent and contracted staff at all levels
13. 1313
Country Selection
Quality and
risk filter
All
countries
1
• Political stability – Economist Intelligence Unit
• Availability of qualified, experienced Investigators
• Adequacy of Pfizer in-country clinical research/monitoring
infrastructure
• Audit performance history
15. 1515
Country Selection
• Country performance is assessed against evaluation criteria broken
down into three categories: good, acceptable, and poor performance for
each metric
Assessment
of
performance
metrics
3
Startup
Speed
Cycle
Time
Subjects
per site
Recruitment
Reliability
MBR
($000)
Pts/FTE
Good
Acceptable
Poor
≤90
90-135
>135
≤270
270-360
≥360
≥12
8-12
≤ 8
≥115
75-115
≤75
≤ 150
150-250
≥250
≥55
40-55
≤40
Start up speed – median #days from receipt of protocol package to latter of regulatory approval or ethics approval
Cycle time – median #days from regulatory approval to LSFV
Recruitment reliability - # actual subjects randomised as percentage of # planned per study
Monitor Burden Rate (MBR) – Fully loaded annual cost of a monitor/CRA
16. 1616
Ranges for Performance Metrics
Clinical Trial Metrics & Ranges
Metric Range Average
Startup Speed 57 – 656 days 154 days
Final approved
protocol to last
subject first visit
109 – 1508 days 373 days
Subjects /site 4 – 83 subjects 15 subjects
Recruitment
reliability
9 - 494 % 133 %
Monitoring
Burden Rate*
$26K – $363K $141K
Subjects/ FTE 6 – 284 subjects 60 subjects
Performance
metrics
*Monitoring Burden Rate is the fully loaded cost of supporting a monitor in a country.
17. 1717
Recruitment Reliability
(Actual Patients * Planned Recruitment Period)
(Planned Patients * Actual Recruitment Period)
Actual Patients = Number of randomized patients in the study in the country (RighTrack II)
Planned Recruitment Period = Study planned last subject first visit (EPM) – country planned
first subject first visit (eCPM via initial CMA)
Planned Patients = Number of planned patients in the study in the country (eCPM via initial
CMA)
Actual Recruitment Period = Study actual last subject first visit (EPM) – country actual first subject first
visit (RighTrack II or ClinrepNet)
18. 1818
Ranges for Performance Metrics
Clinical Trial Metrics & Ranges
Metric Range Average
Startup Speed 57 – 656 days 154 days (206)
Subjects /site 4 – 83 subjects 15 subjects (5)
Recruitment
reliability
9 - 494 % 133 % (69%)
Performance
metrics
*Monitoring Burden Rate is the fully loaded cost of supporting a monitor in a country.
19. 1919
Country Selection
Low volume cohort
<1,600 patients
High volume cohort
≥1,600 patients
Core
Non core
Core
Non core
Prioritize based on
quantitative and
qualitative analysis
4
20. 2020
Europe – 14 Core countries
Asia – 9 Core countries
Can/LA/Africa/Middle East – 10 Core countries
New Country Clinical Trials Footprint
US
21. 2121
21
Why is Ireland Non-Core
• Fragmented – research infrastructures not
connected and hard to find. The key opinion leaders
and researchers are there and are performing at
individual level with individual companies. This
activity is not collated, communicated and
connected to showcase Irelands capacity as a
country level.
• Ireland is “person dependent” – you need to know
individuals in order to get connected to the right
chain of knowledge – it is not a “system”
• Performance - not predictable – research approval
processes – especially ethics, protracted negotiation
process for trial cost negotiation as each facility has
different costs for the same service, access to
patient populations in quite diffused with lack of
connectivity between the various points of care e.g.
hospital, GP interface
22. 2222
22
Why is Ireland Non-Core
• Cost of patients – for the number of patients
Irelands can contribute – the cost is too high to
justify the effort. Coupled with the fact that Ireland
has a limited patient population and also a limited
market for the sale of products – the cumulative
effect of the investment risk is not a positive one
• For a number of companies there have been more
findings (and of a more serious nature) in regulatory
inspections in Irish sites compared to sites in the UK
which colours views when it comes to allocating
clinical research between sites in the UK & Ireland
• Industry has been evaluating cost cutting and
productivity enhancement for several years – this
means decisions are made on countries to involve in
trials is not as it used to be “who the medical
director knew”. It is now in the hands of procurement
departments, operational departments whose
bonuses are based on performance of countries
chosen. Ireland has not evolved from the person
based influencing strategy.
23. 2323
23
Why is Ireland Non-Core
• In recent times – the issue of hiring freezes of
nurses has impacted. This has already been
heard in the corridors of BioPharma and once
this message starts to move – the perception is
very hard to shake. The fact that the Irish
economic status and actions are communicated
at global level will not add to confidence in this
area
• Communication strategy for what Ireland has
to offer is fragmented and does not have a
strategic lead. Ireland is NOT the right country
for EVERYTHING and an uncoordinated
communication plan just adds to the perception
of confusing, complicated and not joined up
24. 2424
Conclusions
• Robust root cause analysis as part of a Lean six sigma
continuous improvement process identified a reduction in the
country clinical trials foot print as an imperative to increase
study execution speed and reduce costs while maintaining
quality.
• Analysis of performance data with consideration of cost and
risk factors led to proposed core county foot print of 34
countries representing an approximately 50% reduction.
• Ireland did not make core country footprint
• Ireland has many of the clinical trial jigsaw pieces in place –
but they are not joined to form a picture of a good research
country.
25. 2525
25
Developing a Functioning Clinical Research
System
• The development of a functioning clinical research
system is fundamental to the evolution of LifeSciences
in Ireland.
• Healthcare practitioners play a vital role in identifying
unmet medical needs and giving direction and support
to LifeSciences research.
• The Strategy for Science, Technology & Innovation,
2006 – 2013 (SSTI), highlighted the relatively low levels
of translational and/or clinical research underway in
Ireland and stated that “the introduction of an R&D
culture within mainstream health service has been
relatively slow (and) there is a need to strengthen
considerably the health services research and policy
research capacity nationally”
• The reality today is that the resource pressures faced
by the hospital system means that research has tended
to take ‘second place.’
26. 2626
Summary
• If Ireland is to become a core site for clinical trials
everyone must be committed to making Ireland a
beacon for clinical research and we are currently far
from that
• There is no national vision on how we want to
partner as a country with biopharma re research
• A shared vision would help us focus on what each
part of the chain needs to deliver whilst maintaining
their independence
• All parts of the chain must be working correctly from
hospitals, universities, ethics committees to IMB etc.
27. 2727
Summary
Clinical Trial Research is not a commodity, but a
sophisticated element of technology in a very competitive
environment. Countries wishing to attract high-level clinical
research must offer:
– sophisticated healthcare environment
– professional investigational environment - doctors need explicit
incentives to conduct research (ie "good investigators are good
doctors”)
– institutions should have explicit objectives to engage in CR; they often
charge overheads, so this is a revenue stream, but may be poorly
organized
– countries need to offer access to modern diagnostics and treatments,
so that data generated will have relevance in a rapidly developing
healthcare environment ("future compatibility")
– comprehensive, integrated information systems are very valuable –
they enable effective review/follow up of patients on new treatments
with critical evaluation of new treatments.