This presentation discusses pharmacoeconomic assessment through different phases of drug development and approval. It provides an overview of different types of pharmacoeconomic analyses including cost-minimization analysis, cost-effectiveness analysis, cost-utility analysis, and budget impact modeling. It discusses planning pharmacoeconomic assessments and considerations for real-world pharmacoeconomic assessments. It also covers implementing real-world assessments through dedicated processes, working with different data sources, and closing considerations around recruitment, retention, and the value of real-world pharmacoeconomic assessments.
Pharmacoeconomics is a branch of health economics which compares the value of one drug or a drug therapy to another.
By understanding the principles, methods, and application of pharmacoeconomics, healthcare professionals will be prepared to make better decisions regarding the use of pharmaceutical products and services.
Pharmacoeconomics is a branch of health economics which compares the value of one drug or a drug therapy to another.
By understanding the principles, methods, and application of pharmacoeconomics, healthcare professionals will be prepared to make better decisions regarding the use of pharmaceutical products and services.
Strategy to incorporate pharmacoeconomics into pharmacotherapy Ravi Kumar Yadav
Pharmacoeconomics of the health care intervention is equally important like the safety and efficacy of drug. The various strategies are available to incorporate pharmacoeconomics into pharmacotherapy. The most popular strategies for applying pharmacoeconomics to assess the value of pharmaceutical products and services include using the results of published pharmacoeconomic studies, building economic models, and conducting pharmacoeconomic research.
Strategy to incorporate pharmacoeconomics into pharmacotherapy Ravi Kumar Yadav
Pharmacoeconomics of the health care intervention is equally important like the safety and efficacy of drug. The various strategies are available to incorporate pharmacoeconomics into pharmacotherapy. The most popular strategies for applying pharmacoeconomics to assess the value of pharmaceutical products and services include using the results of published pharmacoeconomic studies, building economic models, and conducting pharmacoeconomic research.
Evaluating Health Technology Assessment Reports and New Assessment Techniques...bpstat
2nd Annual Health Outcomes and Pharmacoeconomics Research Conference
• Setting up internal processes to ensure proper Health
Technology Assessment (HTA)
• Exploring initiatives to translate reported outcomes to
ensure proper understanding of data
• Assessing the key HTA entities in the U.S. and establishing
assessment protocol
• Differentiating HTA strategies with new technology
assessment strategies to improve assessment processes
This is the summary of a webinar I delivered in November 2012 on Health Outcomes Liaisons and their roles in supporting managed care busines and ACO business.
The revised OECD Health Systems Performance Framework: methodological issues ...Sax Institute
The OECD is a leading organization in the international measurement of health system performance. The OECD Expert Group on Health Care Quality Indicators (HCQI) has recently revised its performance framework, identifying core indicators and highlighting new directions. Although improving, the capacity of countries to deliver more accurate standardized indicators still needs to be fostered. A particular aspect that deserves attention is the design, planning and implementation of public performance reporting. Such activity, strictly interrelated to the capacity of the information infrastructure, also depends from cultural, organizational and political conditions that can be differently present at the international level. The applicability of standardized principles and the evidence of improved outcomes due to public reporting systems is still questioned to a large extent. A first international conference on the topic of hospital performance reporting has been organized in Rome, Italy in 2014, followed by a second event held in Seoul, South Korea, in 2015. In his talk, Fabrizio Carinci will present recent developments of OECD projects, including:
• state of the art in the definition of OECD performance indicators
• challenges emerging from OECD R&D studies
• transferability and use of definitions at sub-national and provider level
• applicability for hospital performance benchmarking and geographical variation
• limitations imposed by the legislation on privacy and data protection
• an overarching vision of “essential levels of health information”
Through practical examples drawn from his direct experience as Member of the Bureau of the HCQI and other relevant Boards, Prof. Fabrizio Carinci will discuss the state of the art, the role played by national governments (including Australia), and potential avenues for mutual collaboration.
www.interlinkconsultancy.com
Healthcare industry challenges and pharmacoeconomic solutions.The pharma industry product pipelines are drying up, leading to a high dependence on existing products for survival. The branded generic drugs segment has become commoditized due to ever increasing and fierce
competition.Price plays a major role in drug prescription and buying decisions. High price may not always assure high quality or more benefits and companies are finding it difficult to substantiate higher prices..
Pharmacoeconomic Assessment through Market Approval and Beyond: Theory and Op...Medpace
Pharmacoeconomic assessment of a drug, medical device, or other healthcare product can take on many forms and occur at multiple points in the development cycle. Cost-effectiveness analysis, a major component of pharmacoeconomic assessment, has traditionally occurred in the later phases of product development—either as a piggy-back to a phase III or pivotal clinical trial, or peri-authorization.
This presentation explains the main features of medicines which will be developed and authorised via the adaptive pathways. It provides a definition of real world evidence and the caveats associated with the use and analysis of real world evidence in drug development.
Four strategies to upgrade clinical trial quality in this computerized world ...Pubrica
• Biostatistics Services is important for collecting, reviewing, presenting, and interpreting data in clinical research.
• Applications of clinical biostatistics services are in different areas, such as epidemiology, clinical trials, population genetics, the biology of structures, and more.
Reference : https://pubrica.com/services/research-services/biostatistics-and-statistical-programming-services/
Continue Reading: http://bit.ly/36nwtcs
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Paying for performance to improve the delivery of health interventions in LMICsReBUILD for Resilience
This presentation from Sophie Witter & Karin Diaconu of Queen Margaret University, UK outlines the findings from a Cochrane review undertaken by the team on paying for performance to improve the delivery of health interventions in low and middle-income countries.
Rising Importance of Health Economics & Outcomes ResearchCitiusTech
Health Economics & Outcomes Research (HE&OR) guides stakeholders to make informed decisions regarding patient access to drugs and services. This document highlights specific use cases for healthcare information technology that add value to HE&OR.
Predicting Patient Adherence: Why and HowCognizant
To contain costs and improve healthcare outcomes, players across the value chain must apply advanced analytics to measure and understand patients’ failure to follow treatment therapies, and to then determine effective remedial action. This white paper lays out a framework for enabling patient adherence management and some general prescriptions on how to convert lofty concepts to meaningful action.
> Why HEOR?
> Costs, Consequences and Perspectives
> Key Stakeholders in HEOR
> What is Health Economics and Pharmaco-economic Research?
> Economic Evaluations
> Incremental Cost Effectiveness Ratio (ICER)
> Concept of HRQoL
> Comparative Effectiveness Research (CER)
> Pragmatic Clinical Trials
> Observational Studies
> Systematic Reviews and Meta-Analysis
> Application of CER
> Health Technology Assessment (HTA)
> Real World Evidence (RWE)
> Patient Reported Outcomes (PROs)
> Patient Focused Drug Development (PFDD)
> Application of Health Economic Evaluations
> Challenges and Barriers
Wielding the Double-Edge Sword of Cardiac Biomarkers in Clinical Trials: A Di...Medpace
Learn best practices for utilizing cardiac biomarkers across various components of a clinical trial from Dr. James Januzzi, a leading expert in cardiovascular biomarkers.
Avoiding Common Pitfalls in Cell and Gene Therapy TrialsMedpace
Our experts will dive into case studies explaining the issues that arose with past projects, and how these studies got back on track. The knowledge gained from these experiences accelerate CGT development by avoiding potential pitfalls and getting ahead of regulatory and operational issues. Our team will walk you through the delays associated with these pitfalls and how to avoid them.
Considerations for the Next Wave of COVID-19 DevelopmentMedpace
What did we learn from the first wave of COVID-specific studies that can be applied to those studies that will follow? Medpace has gathered some of its medical and operational team experts who have been on the front-line in designing and conducting trials for SARS-CoV-2 to answer some frequently asked questions, trends they see emerging and considerations for future development.
COVID-19 Product Development and Clinical Trials: Considerations from Europea...Medpace
Join experts from Medpace’s regulatory and operational teams in this webinar as they provide insights and considerations on how to accelerate product development for COVID-19 during different stages
Part 3: Rare Disease Clinical Development – Strategies for Ensuring Endpoint ...Medpace
n this free webinar, Medpace partners with Michelle Eagle of ATOM International, a provider of CE training for clinical trials across the world, to discuss approaches and steps that can be taken to ensure quality and integrity.
Getting Ahead of the Evolving Landscape in RadiopharmaceuticalsMedpace
In this webinar devoted to radiopharmaceuticals, the featured speakers will explore the scientific, operational and regulatory considerations for radiopharmaceuticals. With a focus on oncology, they will discuss the current regulatory landscape and how this impacts overall development programs. The speakers will explore the challenges of conducting radiopharmaceutical trials, offering insights into trial start-up, site selection and operational aspects to seamlessly execute these studies as part of clinical development plans.
Challenges and Considerations in Clinical Development of "Targeted Therapies"...Medpace
In this webinar, Medpace experts discuss key clinical, operational and laboratory considerations, lessons-learned, and best practices for accelerating the global development of safe and effective targeted therapeutics, using acute myeloid leukemia (AML) to highlight the complexities.
The RACE for Children Act Will Change the Landscape for Pediatric Cancer Rese...Medpace
In this webinar, we explore the regulatory implications of the RACE for Children Act and what this law means for your development program, particularly with navigating the change in requirements for pediatric oncology trials. Furthermore, we explore the challenges of executing oncology trials in pediatric populations and offer insight into design and operational aspects to seamlessly execute these studies as part of your clinical development plan
Identifying High Performing Sites and Engaging PatientsMedpace
One of the biggest challenges facing any clinical trial is how to identify the sites with the greatest potential to engage and retain patients. Applying decades of experience to the topic, Medpace experts will share considerations, lessons-learned and best practices for developing patient recruitment strategies to put you on the path for optimal success.
Challenges and Considerations in Designing and Conducting Immuno-Oncology Cli...Medpace
Given the accelerating pace of immuno-oncology clinical research, awareness of the specific challenges and considerations in designing and conducting successful trials for these new agents is critical.
Webinar: Oncology Trial Recruitment: Challenging Indications and Challenging ...Medpace
Medpace experts discuss how to overcome oncology recruitment challenges for clinical trials for specific populations, indications, and challenging studies.
Local Advanced Lung Cancer: Artificial Intelligence, Synergetics, Complex Sys...Oleg Kshivets
Overall life span (LS) was 1671.7±1721.6 days and cumulative 5YS reached 62.4%, 10 years – 50.4%, 20 years – 44.6%. 94 LCP lived more than 5 years without cancer (LS=2958.6±1723.6 days), 22 – more than 10 years (LS=5571±1841.8 days). 67 LCP died because of LC (LS=471.9±344 days). AT significantly improved 5YS (68% vs. 53.7%) (P=0.028 by log-rank test). Cox modeling displayed that 5YS of LCP significantly depended on: N0-N12, T3-4, blood cell circuit, cell ratio factors (ratio between cancer cells-CC and blood cells subpopulations), LC cell dynamics, recalcification time, heparin tolerance, prothrombin index, protein, AT, procedure type (P=0.000-0.031). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and N0-12 (rank=1), thrombocytes/CC (rank=2), segmented neutrophils/CC (3), eosinophils/CC (4), erythrocytes/CC (5), healthy cells/CC (6), lymphocytes/CC (7), stick neutrophils/CC (8), leucocytes/CC (9), monocytes/CC (10). Correct prediction of 5YS was 100% by neural networks computing (error=0.000; area under ROC curve=1.0).
Adv. biopharm. APPLICATION OF PHARMACOKINETICS : TARGETED DRUG DELIVERY SYSTEMSAkankshaAshtankar
MIP 201T & MPH 202T
ADVANCED BIOPHARMACEUTICS & PHARMACOKINETICS : UNIT 5
APPLICATION OF PHARMACOKINETICS : TARGETED DRUG DELIVERY SYSTEMS By - AKANKSHA ASHTANKAR
Muktapishti is a traditional Ayurvedic preparation made from Shoditha Mukta (Purified Pearl), is believed to help regulate thyroid function and reduce symptoms of hyperthyroidism due to its cooling and balancing properties. Clinical evidence on its efficacy remains limited, necessitating further research to validate its therapeutic benefits.
The Gram stain is a fundamental technique in microbiology used to classify bacteria based on their cell wall structure. It provides a quick and simple method to distinguish between Gram-positive and Gram-negative bacteria, which have different susceptibilities to antibiotics
Basavarajeeyam is a Sreshta Sangraha grantha (Compiled book ), written by Neelkanta kotturu Basavaraja Virachita. It contains 25 Prakaranas, First 24 Chapters related to Rogas& 25th to Rasadravyas.
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
Best Ayurvedic medicine for Gas and IndigestionSwastikAyurveda
Here is the updated list of Top Best Ayurvedic medicine for Gas and Indigestion and those are Gas-O-Go Syp for Dyspepsia | Lavizyme Syrup for Acidity | Yumzyme Hepatoprotective Capsules etc
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
Knee anatomy and clinical tests 2024.pdfvimalpl1234
This includes all relevant anatomy and clinical tests compiled from standard textbooks, Campbell,netter etc..It is comprehensive and best suited for orthopaedicians and orthopaedic residents.
2. Agenda for Today’s Presentation
2 Physician Led | Therapeutically Focused
o Eat Lunch
o Try to Stay Awake!!!
o Overview of Pharmacoeconomic (PE) Assessment
o Planning PE Assessment
o Real World PE (RWPE) Assessment
o Implementing RWPE Assessment
o Working with Data
o Closing Considerations
o Questions
4. Types of PE Assessment to be Discussed
4 Physician Led | Therapeutically Focused
o Cost-minimization analysis
o Cost-effectiveness analysis
o Cost-utility analysis
o Budget impact modeling
5. Cost-Minimization Analysis (CMA)
5 Physician Led | Therapeutically Focused
o Compare costs of two or more drugs or therapies
to determine least costly option
Baseline costs include acquisition costs as well as
costs of preparation and administration
Additional costs depend on perspective of analysis
o Main benefit: cheaper and easier than cost-
effectiveness analysis
o Main drawback: assumption that two drugs or
therapies are used at equivalently effective doses
6. Cost-Effectiveness Analysis (CEA)
6 Physician Led | Therapeutically Focused
o Considers both costs and effectiveness of two or
more drugs or therapies
Costs measured in monetary unit of interest (Eg, $)
Effectiveness generally measured using one or more
clinical outcome (Eg, years of life saved)
o Main outcome is incremental cost-effectiveness
ratio (ICER): (∆ Costs / ∆ Effectiveness)
Eg, incremental cost per life year saved
o ICER compared against willingness-to-pay (WTP)
thresholds to determine if cost-effective, cost-
saving, or cost-neutral
8. Cost-Utility Analysis (CUA)
8 Physician Led | Therapeutically Focused
o CEA accounting for quality of time gained or lost
o Quality of life (QOL) measured using utility
Generally ranges from 0 (dead) to 1 (perfect QOL)
o Most common ICER assessed in CUA is cost per
quality-adjusted life year (QALY) gained
9. Budget Impact Modeling (BIM)
9 Physician Led | Therapeutically Focused
o Generally designed for specific audiences,
particularly third party payers
o Measures net cumulative treatment cost with drug
or therapy of interest for specified number of
patients in particular population
o Impact of particular drug or therapy is assessed
as effect on cost per member per month (PMPM)
10. Perspective of PE Assessment
10 Physician Led | Therapeutically Focused
o Who pays for treatment and who benefits?
o Potential perspectives include:
Healthcare provider
Third party payer
Society
o Different perspectives mean different considerations
13. PE Assessment at Different Phases
13 Physician Led | Therapeutically Focused
o Phase II
o Earlier phase III
o Phase III piggyback studies
o Peri-authorization
o Post-authorization
o Contemporaneous with later Phase III is common
but can consider earlier Phase III or Phase II
o Collection of RWPE data?
14. Planning PE Assessment
14 Physician Led | Therapeutically Focused
o Plan must consider:
Disease area
• Acute vs. chronic vs. oncology?
• Recurrence timeframe?
All relevant phases
Sponsor budget
• CEA for publication vs. BIM for use with payers?
16. Why RWPE?
16 Physician Led | Therapeutically Focused
o Differentiation in costly yet lucrative landscape
$2.6 billion to bring new drug to market (Tufts CCSD)
o Development cycle does not end with approval
Real world research, including RWPE, can drive new
earlier phase research, in turn driving new real world
research
Sustain value across product lifecycle
o Collect extensive effectiveness and safety data
More relevant than literature-based models
More robust than earlier phase clinical data
o True cost-effectiveness rather than cost-efficacy
17. Are Payers the True Decision Makers?
17 Physician Led | Therapeutically Focused
o Roles of FDA and payers, including Medicare and
Medicaid, are constantly evolving
Correcting Signals for Innovation in Healthcare
Medicaid expansion under Affordable Care Act
o Drug approval becoming “easier” (Forbes)?
2008: 50% of NMEs approved by FDA
2014: 88% of NMEs approved
o US District Court ruling re: Amarin’s Vascepa®
o Increased emphasis on generation and
dissemination of evidence aimed at payers
Real World Evidence/Outcomes liaisons
18. 18 Physician Led | Therapeutically Focused
o Three recommendations:
1. Replace tax exclusion for employer-provided health
insurance with tax credit
2. Strengthen Medicare coverage determination
process
3. Experiment with reference pricing for certain
therapies in Medicare
o RWPE can inform last two recommendations
19. Epidemiologic Study Designs
(by Traditional Strength of Evidence)
19 Physician Led | Therapeutically Focused
1. Randomized controlled trial
2. Community trial
3. Prospective cohort study
4. Retrospective cohort study
5. Case-control study
6. Cross-sectional study
7. Ecologic study
8. Case report or case series
Observational
Interventional
Descriptive
Analytic
Strength of evidence: ability to establish causal link
20. Real World/Observational Epidemiology
20 Physician Led | Therapeutically Focused
o Data gathered in naturalistic (real world) setting
o Variables of interest include:
Exposure
• Harmful (Eg, behavior) or protective (Eg, drug, vaccine)
Outcome
• Disease or health state
• Time to event
Potential confounders
o If treatment involved, prescribed in usual manner
Therapy assignment not decided in advance by protocol
No diagnostic or monitoring procedures other than those
ordinarily applied
21. RWPE Builds on Observational Epidemiology
o Registries are cohort studies
Specifically prospective and retrospective cohort studies
21 Physician Led | Therapeutically Focused
24. RWPE Means Dynamic
Data Collection and Analysis
24 Physician Led | Therapeutically Focused
o Specifically, continually updated data streams
allow for refinement of CEA and BIMs to reflect
most up-to-date data, providing consistently
refreshed ICER and PMPM cost estimates
o How is this implemented?
Dedicated processes
25. Dedicated Processes for RWPE
o Protocol must describe study challenges and
methods for resolution, while addressing (Giezen
et al. 2009, Kiri 2012):
Ecological validity
Achievable study objectives
Tailored operational processes
Study Design and Protocol
25 Physician Led | Therapeutically Focused
26. Dedicated Processes for RWPE
o Ensure straightforward navigation for electronic
case report forms (eCRFs)
o Provide guidance for online queries
o Design database to be flexible and easy to use
o Include all stakeholders in design as well as any
changes
Sites
Analysts
Submissions team (if relevant)
eCRF Design and Development
26 Physician Led | Therapeutically Focused
27. Dedicated Processes for RWPE
o Obtain permissions and licenses
o Validate per FDA guidance
o Address HIPAA and security concerns
o Plan for incorporating PRO data into PE
assessment
Ie, primary EQ-5D scores are preferred source of
utility data for NICE
Patient Reported Outcomes (PROs)
27 Physician Led | Therapeutically Focused
28. Dedicated Processes for RWPE
o Incorporate alerts into analysis dataset programs
o Use templates designed for repeated delivery
o Design output programs with locked, validated
modules as well as modules that are intended to
evolve and change
o Structure eCRF rules to promote easy updates
o Normalize dataset design and use of metadata to
support multiple data cuts
Programming and Data Governance
28 Physician Led | Therapeutically Focused
30. Merging Data from Multiple Sources
o RWPE involves coordination with healthcare
providers and payers to collect regularly
refreshed, relevant data such as electronic health
records (EHR), PROs, and costs/reimbursements
o Timing and costs of implementation are concerns
o Therefore, data collection must be as efficient as
possible
Efficiency derives from well-designed and well-
integrated electronic data capture (EDC) system
The Crux of the Matter for RWPE
30 Physician Led | Therapeutically Focused
31. Cost/Reimbursement Data Sources
31 Physician Led | Therapeutically Focused
o Patient records at doctor’s office
CMS 1450 (UB04 Uniform Bill)
o Claims databases
Medicare and private
o Coding
CPT, other codes
o RED BOOK
o Published literature
o Government reports
32. o Real world effectiveness study
Prospective cohort
Retrospective cohort
o Claims data
Standalone
Link with study data
Data Sources: Effectiveness and Claims
32 Physician Led | Therapeutically Focused
=
Payer
Study
Payer Study
33. Merging Data from Multiple Sources
CDISC Healthcare Link Initiative
33 Physician Led | Therapeutically Focused
34. Merging Data from Multiple Sources
FDA EHR Demonstration Project
34 Physician Led | Therapeutically Focused
35. Merging Data from Multiple Sources
National Claims Database?
35 Physician Led | Therapeutically Focused
36. Merging Data from Multiple Sources
o Standardize any coding as well as definitions of events
and outcomes (Abbing et al. 2010, Blake et al. 2012,
Andrews et al. 2012)
o Foster harmonization across multiple sources by using
common data model (Coloma et al. 2011)
Standardized input files can be created from each
database, linked via patient ID, and managed locally
o Develop storage system making individual databases
accessible from common platform as anonymized data
at appropriate level
Based on common data model in compliance with
guidelines relevant for each database (Trifirò et al. 2014)
Process should involve stakeholders for each database
Some Thoughts
36 Physician Led | Therapeutically Focused
37. Target Data for Hybrid EHR Sourcing
37 Physician Led | Therapeutically Focused
Problem data for
EHR systems
Stop dates
Scaled data
Surveys/PROs
Costs
Better data for
EHR systems
Coded for payments
Already transactional
(lab systems,
pharmacy)
Most problematic
data for sites
High volume
Complex
Query-prone
Research vs.
Healthcare
Labs
Meds
39. Recruitment and Retention
39 Physician Led | Therapeutically Focused
o Well-integrated EDC, EHR, and ePRO will
enhance retention of sites and patients
o Recruitment populations for RWPE studies differ
from populations for interventional trials
o RWPE studies tend to be longer
Direct impact on site motivation
o Gauging and developing site experience and
motivation are essential in optimizing enrollment
Establishing study expectations from outset
Capacity for integration with EDC?
Training?
40. Too Much of a Good Thing?
40 Physician Led | Therapeutically Focused
41. In Other Words…
41 Physician Led | Therapeutically Focused
o … is RWPE worth the hassle?
o Blommenstein et al. conclude…
o In short, YES, if done properly and efficiently
42. Future Considerations
42 Physician Led | Therapeutically Focused
o Product development cycle does not end with
approval
o PE assessment in earlier and later phases,
including RWPE, is essential to demonstrating
product value
o Real world research, including RWPE, can drive
innovation
o RWPE demonstrates market leadership
o Flexibility is essential