Value of Medical Laboratory Science Personnel and Clinical Laboratory Service...Sheleste Vergara
Web-Based Presentation by:
Sheleste Anne Marie R. Vergara
BMLS - 1B
American Society for Clinical Laboratory Science, House of Delegates. ASCLS Position Paper: Patient Safety and Clinical Laboratory Science [Internet]. 2015 Jul [cited 14 Dec 2020]
https://ascls.org/value-of-clinical-laboratory-services/
Value of Medical Laboratory Science Personnel and Clinical Laboratory Service...Sheleste Vergara
Web-Based Presentation by:
Sheleste Anne Marie R. Vergara
BMLS - 1B
American Society for Clinical Laboratory Science, House of Delegates. ASCLS Position Paper: Patient Safety and Clinical Laboratory Science [Internet]. 2015 Jul [cited 14 Dec 2020]
https://ascls.org/value-of-clinical-laboratory-services/
The 10th Annual Utah Health Services Research Conference: Evaluating information quality in the detection of pediatric asthma encounters. By: Andrew J. Knighton, PhD, CPA - Institute for Healthcare Delivery Research Intermountain Healthcare
Patient Centered Research Methods Core, University of Utah, CCTS
The Importance of measuring outcomes, including Patient Reported Outcome Measures (PROMS)
BAOT Lifelong Learning Event
10 November 2010
Dr Alison Laver-Fawcett
Head of Programme, BHSC(Hons) Occupational Therapy
York St John University
evidence based practice is best for the people working with patients
ebp should be used by the heath care provider.
ebp based upon clinical experties
best research evidence
patient preference and values
Clinical Questions types .
A Hierarchy of Preprocessed Evidence.
EBM definition and value.
Knowledge and Skills Necessary for Optimal Evidence-Based Practice.
Basic computer and internet knowledge for electronic searching of the literature
Difference between cohort, cross sectional and case control study - Scientifi...Pubrica
In Brief:
1. Cross-sectional studies, case-control studies and cohort studies are collectively known as observational studies.
2. Observations and not interventions are carried out by the investigator.
3. This will act as a quick reference table for researchers and authors.
4. This blog tries to discuss each of the observational studies methods laying emphasis on what their strengths and weaknesses are by comparing them.
Learn More: https://pubrica.com/academy/
Contact us:
Web: https://pubrica.com/
Email: sales@pubrica.com
WhatsApp: 91 9884350006
United Kingdom: 44-1143520021
Are we ready for disruption in Translational Research through Digital Medicine?Ashish Atreja, MD, MPH
This is the slide deck that was presented at Translational Science 2016. Touches upon evidence generation as one of the most desired but expensive process in medical science. Provides examples of how Social Media, medical apps, quantified self movement are leading to patient generated data that can disrupt evidence generation process.
The Indian Dental Academy is the Leader in continuing dental education , training dentists in all aspects of dentistry and
offering a wide range of dental certified courses in different formats.for more details please visit
www.indiandentalacademy.com
EVIDENCE-BASED PRACTICE IN NURSING.docxHaraLakambini
-Evidence-based Practice in Nursing
-Steps of Evidence-Based Practice
-Hierarchy of Evidence | Quantitative Questions
-Elements of Evidence-Based Practice
-Nursing Research
-Types of Research
-Rights of Human Subject
-Comparison of Nursing Process with Research Process Table
-Performance Improvement in Nursing
-Examples of Performance Improvement Models
-Relationship between Evidence-Based Practice, Research, and Performance Improvement
-Similarities and Differences among Evidence-Based Practice, Research, and Performance Improvement
The 10th Annual Utah Health Services Research Conference: Evaluating information quality in the detection of pediatric asthma encounters. By: Andrew J. Knighton, PhD, CPA - Institute for Healthcare Delivery Research Intermountain Healthcare
Patient Centered Research Methods Core, University of Utah, CCTS
The Importance of measuring outcomes, including Patient Reported Outcome Measures (PROMS)
BAOT Lifelong Learning Event
10 November 2010
Dr Alison Laver-Fawcett
Head of Programme, BHSC(Hons) Occupational Therapy
York St John University
evidence based practice is best for the people working with patients
ebp should be used by the heath care provider.
ebp based upon clinical experties
best research evidence
patient preference and values
Clinical Questions types .
A Hierarchy of Preprocessed Evidence.
EBM definition and value.
Knowledge and Skills Necessary for Optimal Evidence-Based Practice.
Basic computer and internet knowledge for electronic searching of the literature
Difference between cohort, cross sectional and case control study - Scientifi...Pubrica
In Brief:
1. Cross-sectional studies, case-control studies and cohort studies are collectively known as observational studies.
2. Observations and not interventions are carried out by the investigator.
3. This will act as a quick reference table for researchers and authors.
4. This blog tries to discuss each of the observational studies methods laying emphasis on what their strengths and weaknesses are by comparing them.
Learn More: https://pubrica.com/academy/
Contact us:
Web: https://pubrica.com/
Email: sales@pubrica.com
WhatsApp: 91 9884350006
United Kingdom: 44-1143520021
Are we ready for disruption in Translational Research through Digital Medicine?Ashish Atreja, MD, MPH
This is the slide deck that was presented at Translational Science 2016. Touches upon evidence generation as one of the most desired but expensive process in medical science. Provides examples of how Social Media, medical apps, quantified self movement are leading to patient generated data that can disrupt evidence generation process.
The Indian Dental Academy is the Leader in continuing dental education , training dentists in all aspects of dentistry and
offering a wide range of dental certified courses in different formats.for more details please visit
www.indiandentalacademy.com
EVIDENCE-BASED PRACTICE IN NURSING.docxHaraLakambini
-Evidence-based Practice in Nursing
-Steps of Evidence-Based Practice
-Hierarchy of Evidence | Quantitative Questions
-Elements of Evidence-Based Practice
-Nursing Research
-Types of Research
-Rights of Human Subject
-Comparison of Nursing Process with Research Process Table
-Performance Improvement in Nursing
-Examples of Performance Improvement Models
-Relationship between Evidence-Based Practice, Research, and Performance Improvement
-Similarities and Differences among Evidence-Based Practice, Research, and Performance Improvement
Evidence based nursing practice is one of most important for perfect and accurate in terms of saving a life.this presentation covers almost all aspect of EBD
SLC CME- Evidence based medicine 07/27/2007cddirks
Saint Luke's Care, a quality improvement organization within Saint Luke's Health System, presents a CME presentation by Dr. Brent Beasley on Evidence Based Medical Care.
Module 5 (week 9) - InterventionAs you continue to work on your .docxroushhsiu
Module 5 (week 9) - Intervention
As you continue to work on your assignment, you will be pulling in some information from your work throughout this course. For one part of this presentation, you will be identifying the current problem (or opportunity for change). This was part of your discussion in the week 2 assignment PowerPoint.
You will also propose an evidence-based intervention to address this particular problem. This intervention should be derived from the literature you have found and presented in your critical appraisal template.
As you have seen, these assignments have provided you the ability to identify a problem, develop a PCIOT question, search for evidence related to this PICOT, critically appraise the evidence for a solution to the problem, and now you will identify the solution and disseminate the results.
You are well on your way to becoming evidence-based practitioners!
Week 9!
Nice work on last week’s discussion. As you have discovered, decision aids can be very helpful when providing information for patients and families.
This week, you will continue to work on your assignment for this module. This will be an 8-9 slide PowerPoint presentation in which you will recommend an evidence-based practice change. Review the 4 articles you critiqued to determine what practice change is supported by the literature.
Some of the content for this assignment will be taken from your previous work and some will be new. This PowerPoint is a total of 8-9 slides.
Please review the full assignment details located under the learning resources for module 5.
Please let me know if you have questions
David
Provider perspectives on the utility of a colorectal
cancer screening decision aid for facilitating shared
decision making
Paul C. Schroy III MD MPH,* Shamini Mylvaganam MPH� and Peter Davidson MD�
*Director of Clinical Research, Section of Gastroenterology, Boston Medical Center, Boston, MA, �Study Coordinator, Section of
Gastroenterology, Boston Medical Center, Boston, MA and �Clinical Director, Section of General Internal Medicine, Boston
Medical Center, Boston, MA, USA
Correspondence
Paul C. Schroy III, MD MPH
Boston Medical Center
85 E. Concord Street
Suite 7715
Boston
MA 02118
USA
E-mail: [email protected]
Accepted for publication
8 August 2011
Keywords: decision aids, informed
decision making, shared decision
making
Abstract
Background Decision aids for colorectal cancer (CRC) screening
have been shown to enable patients to identify a preferred screening
option, but the extent to which such tools facilitate shared decision
making (SDM) from the perspective of the provider is less well
established.
Objective Our goal was to elicit provider feedback regarding the
impact of a CRC screening decision aid on SDM in the primary care
setting.
Methods Cross-sectional survey.
Participants Primary care providers participating in a clinical trial
evaluating the impact of a novel CRC screening d ...
THE NEED FOR EVIDENCE-BASED PRACTICE
STEPS OF EVIDENCE-BASED PRACTICE
PICOT FORMAT IN EBP
RATING SYSTEM FOR THE HIERARCHY OF EVIDENCE: QUANTITATIVE QUESTIONS
ELEMENTS OF EVIDENCE-BASED ARTICLES
INTEGRATE THE EVIDENCE
EVALUATE THE OUTCOMES OF THE PRACTICE DECISION OR CHANGE
COMMUNICATE THE OUTCOMES OF THE EVIDENCE-BASED PRACTICE DECISION
SUSTAIN KNOWLEDGE USE
NURSING RESEARCH
TRANSLATION RESEARCH
5 PHASES OF TRANSLATION RESEARCH
OUTCOMES RESEARCH
SCIENTIFIC METHOD
CHARACTERISTICS OF SCIENTIFIC RESEARCH
NURSING AND THE SCIENTIFIC APPROACH
TYPES OF RESEARCH
TYPES OF RESEARCH APPROACH
RESEARCH PROCESS
RIGHTS OF HUMAN SUBJECT
COMPARISON OF STEPS OF THE NURSING PROCESS WITH THE RESEARCH PROCESS
Performance Improvement
Performance Improvement Programs
EXAMPLES OF PERFORMANCE IMPROVEMENT MODELS
THE RELATIONSHIP BETWEEN EBP, RESEARCH, AND PERFORMANCE IMPROVEMENT
SIMILARITIES AND DIFFERENCES AMONG EVIDENCE-BASED PRACTICE, RESEARCH, AND PERFORMANCE IMPROVEMENT
KEY ELEMENTS
About this Webinar: This presentation will discuss the pathway to pharmaceutical treatments in Canada that involve health technology assessment reviews and decision making. Observations on the current challenges and the importance of patient input to inform decision making will also be discussed. Finally, the key elements that can be critical to successful outcomes will be presented.
9 of 13 I VALUE-DRIVENThe Ali & Science of Evidence-Based .docxsleeperharwell
9 of 13 I VALUE-DRIVEN
The Ali & Science of Evidence-Based Care
RESEARCH BY MATTHEW WEINSTOCK
T
he shift to a value-driven delivery model hinges on a
key element: patients' achieving the best possible out-
comes. The linchpin to that is ensuring that clinicians
regularly follovi best practices and adhere to evidence-
based protocols.
"If this [transformation] is about value and value equals qual-
ity divided by cost, then it makes sense that you look at the evi-
dence," says Joseph Pepe, M.D., CEO of Catholic Medical Center,
Manchester, N.H.
Pepe, who served as CMC's chief medical officer for 12 years
before moving into the chief executive role in 2012, acknowledges
that one of the biggest stumbling blocks to instituting evidence-
based practice more broadly is the fear that it is "cookbook medi-
cine." That's a passé notion, he says. Evidence-based care is not
only about following results from the most recent clinical studies,
but blending that with a patient's values and desires, as well as
relying on a physician's judgment.
"Physicians have gotten a bad rap," says Jean Slutsky, direc-
tor of the Center for Outcomes and Evidence at the Agency for
Healthcare Research and Quality, when talking about the percep-
tion that doctors routinely reject the move toward evidence-based
care. "Physicians are lifelong learners. The very nature of what
they do is about learning."
A 2008 AHRQ handbook on implementing evidence-based
care supports the notion that this is not a completely rigid process.
It defines evidence-based care as "the use of current best evidence
I ABOUTTHISSERIES I
H&HN created this exclusive Fiscal Fitness series with the support of the VHA last year to highlight strategies
hospitals are using to improve quality of care while increasing efficiencies and reining in expenses. In 2013,
the series will focus on organizations that are demonstrating high-value health care
with measurable results. Follow the Fiscal Fitness series in our magazine, in our
e-newsletter H&HN Daily and on our website at www.hhnmag.com/fiscalfitness.
in conjunction with clinical expertise and patient values to guide health
care decisions." That definition first was popularized by David Sackett,
a Canadian doctor, in a 1996 British Medical Journal editorial. "Good
doctors use both individual clinical expertise and the best available
external evidence, and neither alone is enough," he argued.
For example, Slutsky says, the evidence may suggest that a patient
be put on a certain medication. Best practice may be to prescribe one
pill a day for 10 days. In a shared-decision model, which is also a critical
part of the process, the physician and patient would discuss the best
option available — perhaps it is using a different drug on the formulary
that's more affordable but requires the patient to take the medication
three times a day.
Another factor to consider: "What level of risk for side effects is
the patient wilHng t.
EVIDENCE –BASED PRACTICES 1
Evidence-Based Practices
Stephanie Petit-homme
Miami Regional University
Professor: Garcia Mercedes
07/05/2021
Evidence-Based Practices to Guide Clinical Practices
In other terms recognized as evidence-based medication, evidence-based scientific practice is elucidated as the careful, obvious, and judicious use of the best indication in creating results for the outstanding care of separate patients. It helps those who brand the choices to device best healthcare practices while drawing the roadmaps for the health system. In clinical trials, the integration of the EBCP entails clinical respiratory medicine considers two fundamental principles. For example, the principle is the hierarchy of the evidence and the art of clinical decision-making.
The interrelationship between the theory, research, and EBP
The relationship between the theory, research, and the EBP supports the three recognition programs. They still relate in terms of the magnet model component of modern knowledge, innovation, and advancement. They describe in a way in which they lead to the promotion of quality in a setting that makes supports professional practices. Second, there is the identification of excellence in giving nursing services to sick people or the people who stay around. For instance, the model, which is other terms the magnet theory, has got five components ( Reddy, 2018).
The first constituent includes transformational management; the additional is structural authorization. The third one is archetypal specialized practices, new information, invention, and upgrading. Lastly, in the model, there are the empirical quality outcomes. For the achievement of the aims of the goals that have been set, there is a need to make sure that the theory, current knowledge innovation, and the improvements and the components that are found in view all the nurses who are located in the levels of the healthcare company need to get involved.
The research has its primary purpose for the help of coming up with knowledge or the validation done for the knowledge that has always been there from before based on the theory. There is systematic, scientific questioning in the research to give the answers to some of the specific questions. It can use the test hypotheses and the rigorous method, the primary purpose of the study being for investigation knowing of the new things and the exploration. There is a need to understand the philosophy of science.
Second, on the EBP, there is no development of the new knowledge or even the learning being validated. The primary purpose of the EBP is to translate the evidence and then apply it to medical executive. It uses the indication available to brand patient-care choices. The EBP goes yonder the exploration as fine as the persevering penchants and ideals. The EBP retains into deliberation that the best indication is for the opinion leaders and the experts. Even though there is the existence of definitiv ...
Similar to Alicyn Campbell EORTC: Quality of Life in Cancer Clinical Trials Conference. May 16 & 17 2019Brussels, Belgium (20)
263778731218 Abortion Clinic /Pills In Harare ,sisternakatoto
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These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
These lecture slides, by Dr Sidra Arshad, offer a quick overview of the physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar lead (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
6. Describe the flow of current around the heart during the cardiac cycle
7. Discuss the placement and polarity of the leads of electrocardiograph
8. Describe the normal electrocardiograms recorded from the limb leads and explain the physiological basis of the different records that are obtained
9. Define mean electrical vector (axis) of the heart and give the normal range
10. Define the mean QRS vector
11. Describe the axes of leads (hexagonal reference system)
12. Comprehend the vectorial analysis of the normal ECG
13. Determine the mean electrical axis of the ventricular QRS and appreciate the mean axis deviation
14. Explain the concepts of current of injury, J point, and their significance
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. Chapter 3, Cardiology Explained, https://www.ncbi.nlm.nih.gov/books/NBK2214/
7. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
ABDOMINAL TRAUMA in pediatrics part one.drhasanrajab
Abdominal trauma in pediatrics refers to injuries or damage to the abdominal organs in children. It can occur due to various causes such as falls, motor vehicle accidents, sports-related injuries, and physical abuse. Children are more vulnerable to abdominal trauma due to their unique anatomical and physiological characteristics. Signs and symptoms include abdominal pain, tenderness, distension, vomiting, and signs of shock. Diagnosis involves physical examination, imaging studies, and laboratory tests. Management depends on the severity and may involve conservative treatment or surgical intervention. Prevention is crucial in reducing the incidence of abdominal trauma in children.
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.
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).
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
Alicyn Campbell EORTC: Quality of Life in Cancer Clinical Trials Conference. May 16 & 17 2019Brussels, Belgium
1. EORTC: QUALITY OF LIFE IN
CANCER CLINICAL TRIALS
MAY 16 & 17 2019
BRUSSELS, BELGIUM
Regulatory Considerations in
Patient Reported Outcomes:
Past, Present, and Future State
2. BIO: ALICYN CAMPBELL
Alicyn Campbell is the Founder of Patient Relevant Evidence which provides strategic
advising for patient-centric evidence generation. Alicyn has over 12 years of
experience developing and implementing patient relevant endpoint strategies across
all areas of oncology from the sponsor perspective.
For 7 years Alicyn led Roche/Genentech’s oncology Patient-Centered Outcomes
Research group and was responsible for novel FDA PRO labeling claims for
both Hycela and Hemlibra.
Alicyn has participated in numerous FDA workshops, academic forums, pre-
competitive collaborations and industry groups, including former Vice President
Biden’s Cancer Moonshot Initiative.
Disclosures: Member of the Carevive Systems Inc. Scientific Advisory Board
Research Partner: Clinical Outcomes Solutions
COPYRIGHT 2019 PATIENT RELEVANT EVIDENCE LLC – NO SLIDES MAY BE
REDISTRIBUTED OR REPUBLISHED WITHOUT WRITTEN PERMISSION
2
3. CONTACT INFO
PRE is headquartered in northern California, and has research partners around the
globe.
PHONE: +1 415 275 1229
EMAIL: alicyn@patientrelevantevidence.com
COPYRIGHT 2019 PATIENT RELEVANT EVIDENCE LLC – NO SLIDES MAY BE
REDISTRIBUTED OR REPUBLISHED WITHOUT WRITTEN PERMISSION
3
4. WHY WE ARE HERE
Dr. Janet Woodcock, CDER, FDA:
"It turns out that what is really bothering the patient and what is really bothering the
doctor can be radically different things; patients are true experts in their disease”;
“It's clear you have to start with an understanding of the impact of the disease on the
people who have it, and what they value most in terms of alleviation before you set up a
measurement and go forward with truly patient-focused drug development."
The term ‘clinical benefit’ was introduced by FDA to describe and better assess
patient-focused outcomes; this is defined as “the impact of treatment on how a
patient feels, functions or survives”
Ref: PDUFA V Clinical Outcome Assessments Public Workshop, April 1, 2015
5. WHERE WE WERE
Poorly defined endpoints
E.g. “to compare quality of life between treatment A and treatment B”
Not starting out with a clear hypothesis, well defined tool(s) to measure the desired construct
E.g. “to explore the difference in QOL between treatment A and treatment B”
Not measuring aspects of disease and treatment most relevant to patients
Post-hoc, tertiary analyses
E.g. choosing the method that best fits the results rather than pre-defining the research question(s)
Variable analytic methods applied to the same tool across researchers
Providing different results & conclusions
Different thresholds for meaningful change applied across the same tool, lacking empirical
evidence to support
Missing data adjustments, or no adjustments, lacking sensitivity analyses in both cases
All of of these combined = reduced credibility of PRO results
6. PRESENT STATE
Alignment on core concepts of interest from regulators and patients
E.g. Disease Symptoms, Physical Functioning, IADLs, Treatment Burden
Alignment on well defined tools
E.g. EORTC, PRO-CTCAE, BPI, MDASI, PROMIS and others.
Well thought out and well defined endpoints
E.g. “Compare the mean change from baseline in EORTC QLQ-C30 Physical Functioning score at week
24 between patients on Treatment A vs. Treatment B in the ITT population”
Alpha spend, inclusion in the hierarchy if labeling intent
Reduced patient burden
Removal of non-core concepts and assessing only those concepts most relevant to patients with the
underlying disease
Clearer thresholds & definitions of meaningful change
Inclusion and application of anchor based methods; CDF curves to complement
7. FUTURE: APPROVALS
Systematic application of the estimand framework (ICH E9 (R1))*
Clear endpoint definitions, determined a priori
We’re getting there, but we’re still not there yet
Alignment between sponsors and regulators balancing rigor and feasibility
E.g. analgesic logs in a global environment
“Content validity”
Better communication between regulators and sponsors up-front, Pre-Ph3 start
Less: “ PRO evidence will be a review issue” then “No.”
More: clear, actionable feedback to allow teams to de-risk labeling concerns by generating any required
empirical evidence while the trial is ongoing
Clearer expectations of filing requests at Pre-Ph3 Meetings
Pre-alignment on what Information Requests (IR) may arise at the start of Phase 3 to enable resource planning for
sponsor timeline
Clearer alignment between payers and regulators on requirements for clinical evidence
*https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E9/E9-R1EWG_Step2_Guideline_2017_0616.pdf
8. FUTURE: COMPARATIVE
TOLERABILITY
Definition: ‘The tolerability of a medical product is the degree to which symptomatic and
non-symptomatic adverse events associated with the product’s administration affect the
ability or desire of the patient to adhere to the dose or intensity of therapy. A complete
understanding of tolerability should include direct measurement from the patient on how
they are feeling and functioning while on treatment.’
Friend of Cancer Research white paper: https://www.focr.org/sites/default/files/
Comparative%20Tolerability%20Whitepaper_FINAL.pdf
9. FUTURE: TRIAL DESIGN AND
EXECUTION
Increase in use of new study designs
E.g. accelerated approval off Ph1 expansion
Single arm
Multi-therapy basket trials
Movement towards decentralized clinical trials
BYOD, one device for all data collection
Systematic patient input into trial design and feasibility
Engaged, triangular communication model Patient
Investigator
SponsorRegulator
10. FUTURE: USE OF ITEM
BANKS / ITEM LIBRARIES
Reducing patient burden by assessing most relevant concepts
Increased reliance on systems that enable flexible inclusion of salient measurement
concepts:
E.g. EORTC, PRO-CTCAE, MDASI, PROMIS
Need to publish and disseminate empirical evidence on validity, sensitivity, specificity
of these item banks / item libraries
Ensure endpoints constructed using these measurement systems will be accepted by key
stakeholders
11. FUTURE: REAL WORLD
EVIDENCE
Increase in novel treatments such as cell and gene therapies where limited empirical evidence
is available at approval
FDA & reimbursement authorities (e.g. Medicare US) are increasingly requiring longitudinal RWE to
demonstrate long term safety & product value
In rare disease, where patients are scarce, PRO as part of routine care can provide valuable
information on the patient experience
Inform endpoint development
Serve as real world controls
Document real world product value for payers
Refine clinician and patient understanding of perceived barriers via empirical evidence
Real world understanding of treatment burden, performance status and tolerability of regimens
Treated-related symptom assessment incorporated into clinical practice
Systematic inclusion of PROs in real-world evidence platforms, part of routine patient care