scholarly journals Challenges and opportunities in real‐world evidence on the renal effects of SGLT ‐2 inhibitors

2021 ◽  
Author(s):  
Gian Paolo Fadini ◽  
Stefano Del Prato ◽  
Angelo Avogaro ◽  
Anna Solini
Keyword(s):  
Real World ◽  
Renal Effects ◽  
Real World Evidence ◽  
Challenges And Opportunities

Practice-Based Research Networks and the Mandate for Real-World Evidence

2018 ◽  
Vol 44 (2-3) ◽  
pp. 219-236 ◽  
Author(s):  
Elizabeth Hall-Lipsy ◽  
Leila Barraza ◽  
Christopher Robertson
Keyword(s):  
Real World ◽  
Clinical Care ◽  
Observational Research ◽  
Research Networks ◽  
Real World Evidence ◽  
Academic Hospitals ◽  
Challenges And Opportunities ◽  
Practice Based Research ◽  
Research Findings ◽  
Primary Care Clinicians

The 21st Century Cures Act encourages the Food and Drug Administration to consider “real-world evidence” in its regulation of the safety and efficacy of drugs and devices. Many have interpreted this mandate to focus on non-randomized observational research. However, we suggest that regulatory science must also move from rarefied academic hospitals to community-based settings, where the vast majority of patients in fact receive care in the fragmented U.S. healthcare system. This move is especially important if innovations are to reach, and be validated in, more diverse populations. A solution can be found in the 183 Practiced-Based Research Networks (“PBRN”), i.e., groups of primary care clinicians and practices in all 50 states working to improve clinical care and translate research findings into practice. This symposium contribution seeks to (1) describe some of the common shortcomings of clinical trials, (2) explore the opportunities and challenges posed by use of real-world evidence as a basis for drug and device regulation, (3) briefly describe the history and evolution of PBRNs, and (4) articulate the challenges and opportunities for using PBRNs to fulfill the 21st Century Cures Act mandate for real-world evidence.

scholarly journals Bridging the Gap Between RCTs and RWE Through Endpoint Selection

2020 ◽  
Vol 55 (1) ◽  
pp. 90-96
Author(s):  
Robert J. LoCasale ◽  
Chris L. Pashos ◽  
Ben Gutierrez ◽  
Nancy A. Dreyer ◽  
Toby Collins ◽  
...  
Keyword(s):  
Real World ◽  
Clinical Relevance ◽  
Patient Benefit ◽  
Real World Evidence ◽  
Challenges And Opportunities

AbstractThis commentary is authored by several industry real-world evidence (RWE) experts, with support from IQVIA, as part of the 'RWE Leadership Forum': a group of Industry Leaders who have come together as non-competitive partners to understand and respond to RWD/E challenges and opportunities with a single expert voice. Here, the forum discusses the value in bridging the industry disconnect between RTCs and RWE, with a view to promoting the use of RWE in the RCT environment. RCT endpoints are explored along several axes including their clinical relevance and their measure of direct patient benefit, and then compared with their real-world counterparts to identify suitable paths, or gaps, for assimilating RWE endpoints into the RCT environment.

scholarly journals Strengthening pharma's contract with society: the value of trusted partnerships between pharma and healthcare facilitated by real-world data

2020 ◽  
Vol 9 (3) ◽  
pp. 155-159
Author(s):  
Michael J Seewald ◽  
Jonathan M Plumb ◽  
Ben Gutierrez ◽  
Johan Liwing ◽  
Maurille Feudjo Tepie ◽  
...  
Keyword(s):  
Real World ◽  
White Paper ◽  
Medical Community ◽  
Real World Data ◽  
World Data ◽  
Real World Evidence ◽  
Challenges And Opportunities

This White Paper is authored by 11 industry real-world evidence (RWE) experts, with support from IQVIA, as part of the ‘RWE Leadership Forum’: a group of industry leaders who come together as noncompetitive partners to understand and respond to internal or external RWD/E challenges and opportunities with a single expert voice. Herein we aim to clarify the rules of engagement between pharma and healthcare in order to establish trust-based partnerships, which will unlock unique value for society, including the medical community and the ultimate beneficiary, the patient.

Invited Commentary: The Prevalent New User Design in Pharmacoepidemiology: Challenges and Opportunities

2020 ◽  
Author(s):  
Kristian B Filion ◽  
Ya-Hui Yu
Keyword(s):  
Public Health ◽  
Decision Making ◽  
Real World ◽  
Simulation Studies ◽  
Public Health Importance ◽  
Treatment History ◽  
Real World Evidence ◽  
User Design ◽  
Challenges And Opportunities ◽  
Study Population

Abstract The prevalent new user design includes a broader study population than the traditional new user approach that is frequently used in pharmacoepidemiologic research. In an article appearing in this issue (Am J Epidemiol. XXXX;XXX(XX):XXXX–XXXX), Webster-Clark and colleagues describe the treatment initiator types included in the prevalent new user design and contrast the causal questions assessed using a prevalent new user design versus a new user design. They further applied a series of simulation studies showing the importance of accounting for treatment history in addition to time since initiation of the comparator in the prevalent new user design. In this commentary, we put their findings in the broader context with a discussion of the strengths and limitations of the prevalent new user design and settings where it may be most useful. The prevalent new user design and new user design both address unique questions of clinical and public health importance. Real-world evidence generated by pharmacoepidemiologic research is increasingly being used by regulators and other knowledge users to inform their decision making. Understanding the causal questions addressed by different designs is crucial in this process; the study by Webster-Clark and colleagues represents an important step in addressing this issue.

1243-P: Novel Use of Natural Language Processing to Identify Reasons for Insulin Discontinuation in Patients with T2DM: A Real-World Evidence Study

Diabetes ◽  
2019 ◽  
Vol 68 (Supplement 1) ◽  
pp. 1243-P
Author(s):  
JIANMIN WU ◽  
FRITHA J. MORRISON ◽  
ZHENXIANG ZHAO ◽  
XUANYAO HE ◽  
MARIA SHUBINA ◽  
...  
Keyword(s):  
Natural Language Processing ◽  
Natural Language ◽  
Language Processing ◽  
Real World ◽  
Real World Evidence

381-P: Real-World Evidence that Impaired Awareness of Hypoglycemia Increases Severe Hypoglycemia Rates in T2DM (InHypo-DM Study)

Diabetes ◽  
2019 ◽  
Vol 68 (Supplement 1) ◽  
pp. 381-P
Author(s):  
ALEXANDRIA RATZKI-LEEWING ◽  
STEWART B. HARRIS ◽  
NATALIE H. AU ◽  
SUSAN WEBSTER-BOGAERT ◽  
JUDITH B. BROWN ◽  
...  
Keyword(s):  
Real World ◽  
Severe Hypoglycemia ◽  
Real World Evidence ◽  
Impaired Awareness
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