The Use of Real‐world Data to Assess the Impact of Safety‐related Regulatory Interventions

2021 ◽  
Author(s):  
Gerald J. Dal Pan
Keyword(s):  
Real World ◽  
Real World Data ◽  
World Data ◽  
Regulatory Interventions ◽  
The Impact

scholarly journals Analysis of real‐world data to investigate the impact of race and ethnicity on response to PD ‐1 and PD‐L1 inhibitors in advanced non‐small cell lung cancers

2021 ◽  
Author(s):  
Kristin L. Ayers ◽  
Tommy Mullaney ◽  
Xiang Zhou ◽  
Jane J. Liu ◽  
Kyeryoung Lee ◽  
...  
Keyword(s):  
Real World ◽  
Race And Ethnicity ◽  
Small Cell ◽  
Small Cell Lung ◽  
Real World Data ◽  
Lung Cancers ◽  
World Data ◽  
The Impact

scholarly journals The Impact Of Direct‐Acting Antivirals On Hepatitis C Viraemia Among People Who Inject Drugs In England; Real‐World Data 2011‐2018

2021 ◽  
Author(s):  
Megan Bardsley ◽  
Ellen Heinsbroek ◽  
Ross Harris ◽  
Sara Croxford ◽  
Claire Edmundson ◽  
...  
Keyword(s):  
Hepatitis C ◽  
Real World ◽  
People Who Inject Drugs ◽  
Direct Acting Antivirals ◽  
Real World Data ◽  
World Data ◽  
Direct Acting ◽  
The Impact

scholarly journals The impact of centralised care of younger AML patients on treatment results: a retrospective analysis of real-world data from a national population-based registry

2021 ◽  
pp. 1-6
Author(s):  
Lukas Semerad ◽  
Zuzana Sustkova ◽  
Petr Cetkovsky ◽  
Pavel Jindra ◽  
Zdenek Koristek ◽  
...  
Keyword(s):  
Retrospective Analysis ◽  
Real World ◽  
Population Based ◽  
Treatment Results ◽  
Real World Data ◽  
World Data ◽  
National Population ◽  
Population Based Registry ◽  
The Impact

PD-0776 A Bayesian approach to evaluate the impact of change in IGRT protocol using real world data

2021 ◽  
Vol 161 ◽  
pp. S608
Author(s):  
I. Fornacon-Wood ◽  
H. Mistry ◽  
C. Johnson-Hart ◽  
J.P.B. O’Connor ◽  
C. Faivre-Finn ◽  
...  
Keyword(s):  
Bayesian Approach ◽  
Real World ◽  
Real World Data ◽  
World Data ◽  
The Impact

VP08 Real-World Data Use In Health Technology Assessments: A Comparison Of Five Health Technology Assessment Agencies

2017 ◽  
Vol 33 (S1) ◽  
pp. 149-150
Author(s):  
Amr Makady ◽  
Ard van Veelen ◽  
Anthonius de Boer ◽  
Hans Hillege ◽  
Olaf Klunger ◽  
...  
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Real World ◽  
Relative Effectiveness ◽  
Internal Validity ◽  
Health Technology ◽  
Real World Data ◽  
World Data ◽  
The Impact

INTRODUCTION:Reimbursement decisions are usually based on evidence from randomized controlled trials (RCT) with high internal validity but lower external validity. Real-World Data (RWD) may provide complimentary evidence for relative effectiveness assessments (REA's) and cost-effectiveness assessments (CEA's) of treatments. This study explores to which extent RWD is incorporated in REA's and CEA's of drugs used to treat metastatic melanoma (MM) by five Health Technology Assessment (HTA) agencies.METHODS:Dossiers for MM drugs published between 1 January 2011 and 31 December 2016 were retrieved for HTA agencies in five countries: the United Kingdom (NICE), Scotland (SMC), France (HAS), Germany (IQWiG) and the Netherlands (ZIN). A standardized data-extraction form was used to extract data on RWD mentioned in the assessment and its impact on appraisal (for example, positive, negative, neutral or unknown) for both REA and CEA.RESULTS:In total, fourty-nine dossiers were retrieved: NICE = 10, SMC = 13, IQWiG = 16, HAS = 8 and ZIN = 2. Nine dossiers (18.4 percent) included RWD in REA's for several parameters: to describe effectiveness (n = 5) and/or the safety (n = 2) of the drug, and/or the prevalence of MM (n = 4). CEA's were included in 25/49 dossiers (IQWiG and HAS did not perform CEA's). Of the twenty-five CEA's, twenty (80 percent) included RWD to extrapolate long-term effectiveness (n = 19), and/or identify costs associated with treatments (n = 7). When RWD was included in REA's (n = 9), its impact on the appraisal was negative (n = 4), neutral (n = 2), unknown (n = 1) or was not discussed in the appraisal (n = 2). When RWD was included in CEA's (n = 11), its impact on the appraisal varied between positive (n = 2), negative (n = 5) and unknown (n = 4).CONCLUSIONS:Generally, RWD is more often included in CEA's than REA's (80 percent versus 18.4 percent, respectively). When included, RWD was mostly used to describe the effectiveness of the drug (REA) or to predict long-term effectiveness (CEA). The impact of RWD on the appraisal varied greatly within both REA's and CEA's.

550 Real World Treatment Trends for Patients TBSA ≤ 20%: Evaluating Important Shifts in Care and Budget Impact of ASCS Adoption

2020 ◽  
Vol 41 (Supplement_1) ◽  
pp. S115-S115
Author(s):  
James H Holmes ◽  
Stacey Kowal ◽  
Cheryl P Ferrufino
Keyword(s):  
Survey Data ◽  
Resource Use ◽  
Real World ◽  
Budget Impact ◽  
Patient Characteristics ◽  
Real World Data ◽  
Treatment Pathways ◽  
World Data ◽  
Burn Care ◽  
The Impact

Abstract Introduction Treatment pathways in burn care are typically determined based on burn center (BC) and patient characteristics, although decisions may be influenced by anecdotal experience, personal preference, and hospital policies/purchasing decisions. Health economic (HE) evaluations can support improved decision-making, identifying the most cost-effective interventions for tailored care. A novel burn care model (BEACON) was developed with burn surgeons over several years and validated through numerous publications, including an assessment of the HE impacts of autologous skin cell suspension (ASCS) use for definitive burn closure. To ensure that BEACON accurately represents the current state of care, it is vital to update data that underpins model projections. This study collected real world data on practice patterns and patient outcomes for the most commonly seen burns (TBSA ≤ 20%) to update the current understanding of standard of care (SOC) costs and outcomes and to refine estimates on the impact of ASCS use in TBSA ≤ 20% patients. Methods Data was collected from a 10% sample of BCs, including: BC and patient characteristics, resource use, inpatient costs, and length of stay (LOS). NBR based inputs in BEACON were updated to reflect survey data for patients with TBSA ≤ 20%, with the ability to view data as a national aggregate sample and across BC characteristics. BEACON estimates patient and BC costs and outcomes across a spectrum of patient profiles (age, gender, inhalation injury, comorbidity status, burn depth, TBSA) and combines information on each patient profile to understand annual budget impact. Key outcomes were compared across the survey sample and published NBR trends. Using the updated BEACON, the BC budget impact of ASCS in burns TBSA ≤ 20% was assessed. Results The survey was collected from 16+ BCs, focusing on inpatient encounters in 2018. LOS was lower than NBR estimates, with some centers reporting LOS per %TBSA far below 1 d/%TBSA. Using the detailed bottom-up estimation of cost from BEACON with survey data, trends suggest total hospital costs for SOC are lower than published NBR charges given shorter LOS and updated cost and resource use assumption. Conclusions Compared to NBR 8.0, contemporary data suggests that fewer small TBSA burns are being treated in the inpatient setting; those treated have a LOS below NBR estimates. When using real world data, the impact of ASCS use in burns TBSA ≤ 20% was still calculated to be cost saving to a BC overall, given reductions in LOS and number of definitive closure procedures. Incorporating ASCS into appropriate TBSA ≤ 20% procedures can still result in a positive financial impact for BCs. Applicability of Research to Practice

scholarly journals PBI86 INVESTIGATION ON THE CURRENT STATUS SURROUNDING BIOLOGICS AND THE IMPACT OF BIOSIMILARS USING JAPANESE REAL-WORLD DATA IN FY2017

2019 ◽  
Vol 22 ◽  
pp. S433
Author(s):  
T. Tsuchiya ◽  
Y. Goto ◽  
K. Tanabe
Keyword(s):  
Real World ◽  
Current Status ◽  
Real World Data ◽  
World Data ◽  
The Impact

Impact of bolus versus continuous infusion of doxorubicin (DOX) on cardiotoxicity in patients with breast cancer (BC) and sarcomas: Analysis of real-world data.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e19123-e19123
Author(s):  
Lee D. Cranmer ◽  
Lisa M. Hess ◽  
Tomoko Sugihara ◽  
Yajun Emily Zhu
Keyword(s):  
Breast Cancer ◽  
Real World ◽  
Early Period ◽  
Cox Proportional Hazards ◽  
Test Duration ◽  
Cardiac Events ◽  
Real World Data ◽  
World Data ◽  
Middle Period ◽  
The Impact

e19123 Background: Doxorubicin continues to play a central role in management of breast cancer and sarcomas. Dose-dependent cardiomyopathy is a challenge in its use. Strategies have been proposed to mitigate this, including administration by continuous intravenous (CIV) infusion as an alternative to bolus (BOL) administration. This study used real world data to explore the impact of DOX administration mode on cardiotoxicity, duration of DOX and time to treatment failure (TTF). Methods: This study used IBM MarketScan claims to identify patients age ≥ 18 who received at least 2 DOX administrations after cancer diagnosis. Patients with history of cardiac events/toxicities were excluded. Cardiac events were compared for BOL versus CIV overall, by tumor site and by regimen during three follow-up periods, early (within 1 year), middle (>1 to 5 years) and late (>5 years), from DOX initiation using Fisher’s exact test. Duration of DOX and TTF, defined as time from initiation of DOX to subsequent systemic therapy, hospice or death, were evaluated using Kaplan-Meier method and unadjusted Cox proportional hazards models. Results: 62,597 patients were eligible, including 38,961 with BC and 1,772 with sarcoma. Most patients had codes for both modes; 1,941 and 7,094 patients had exclusive BOL and CIV codes, respectively. For these patients, mean duration of DOX was longer for BOL vs. CIV (83.9 vs. 65.4 days, p<0.001). Cardiac events for BOL vs. CIV were 6.5% vs. 5.6% (p=0.098) during the early period, 4% vs. 5.1% (p=0.046) middle period, and 0.5% vs. 0.9% (p=0.068) late period. This pattern was consistent for BC and sarcoma and among those who were pre-treated. There were no differences in cardiac events for BOL vs. CIV for the chemotherapy naïve or DOX monotherapy groups (all periods p>0.10) but statistically different for the breast during the middle period, sarcoma at any time, and pretreated subgroup middle period (all p<0.05). TTF favored CIV over BOL among patients with BC (p<0.0001) but BOL over CIV in sarcoma (p=0.002). TTF was not significantly different between BOL and CIV for BC monotherapy (p=0.067) but was significant for sarcoma monotherapy favoring BOL administration (hazard ratio 0.72, 95% confidence interval 0.54-0.95, p=0.02). Conclusions: These data suggest that cardiac events may occur at a similar rate irrespective of mode of DOX administration. Further analyses are needed to understand how these relationships are impacted by other potential risk covariates (eg, age, gender) and by protective factors (eg, dexrazoxane).

scholarly journals Real-World Data on the Impact of COVID-19 on Endoscopic Procedural Delays

2021 ◽  
Vol 12 (6) ◽  
pp. e00365
Author(s):  
Rachel B. Issaka ◽  
Lauren D. Feld ◽  
Jason Kao ◽  
Erin Hegarty ◽  
Brandon Snailer ◽  
...  
Keyword(s):  
Real World ◽  
Real World Data ◽  
World Data ◽  
The Impact
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