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Current Oncology
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The Role of Real World Evidence in Oncology: Opportunities, Results...
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The Role of Real World Evidence in Oncology: Opportunities, Results and Limitations

A special issue of Current Oncology (ISSN 1718-7729). This special issue belongs to the section "Health Economics".

Deadline for manuscript submissions: closed (31 October 2022) | Viewed by 9041

Special Issue Editor

Soo Jin Seung

E-Mail Website
Guest Editor
Sunnybrook Health Sciences Centre, Toronto, ON, Canada
Interests: real-world outcomes; health economics; costing; administrative databases

Special Issue Information

Dear Colleagues,

Real-world evidence (RWE) has been a popular catchphrase for the last 10 years but could be considered the re-branding of clinical data that does not meet the typical randomized phase III study criteria often included in HTA submissions. Variations in patient populations (e.g., comorbidities, genetic mutations, etc.) especially in oncology are another reason why RWE is gaining prominence with its ability to address uncertainty and data gaps and is being accepted by decision-makers around the world. Furthermore, access and the use of cancer registries and linkages to administrative databases is flourishing, resulting in the demand for more clinical, quality of life and utility data outside the confines of a clinical trial and more representative of actual healthcare practices. However, there are still challenges being faced by RWE researchers, from privacy and legal restrictions to lack of consensus by regulatory bodies in terms of establishing RWE guidelines. Therefore, it is not surprising that the journal Current Oncology is preparing a Special Issue titled “The Role of Real World Evidence in Oncology: Opportunities, Results and Limitations” and I am privileged to be the guest editor. The goals are to publish original research in any oncology indication that uses real-world data to determine outcomes, promote and support young investigators with their research, and to highlight similarities and difference between regions and countries.

Sincerely,

Soo Jin Seung
Guest Editor

Manuscript Submission Information

Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All submissions that pass pre-check are peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 100 words) can be sent to the Editorial Office for announcement on this website.

Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Current Oncology is an international peer-reviewed open access monthly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 2200 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.

Keywords

  • real-world evidence
  • data
  • oncology
  • cancer
  • population-based

Published Papers (4 papers)

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Research

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16 pages, 1575 KiB  
Article
Real-World Cost-Effectiveness Analysis: How Much Uncertainty Is in the Results?
by Heather K. Barr, Andrea M. Guggenbickler, Jeffrey S. Hoch and Carolyn S. Dewa
Curr. Oncol. 2023, 30(4), 4078-4093; https://doi.org/10.3390/curroncol30040310 - 07 Apr 2023
Viewed by 2370
Abstract
Cost-effectiveness analyses of new cancer treatments in real-world settings (e.g., post-clinical trials) inform healthcare decision makers about their healthcare investments for patient populations. The results of these analyses are often, though not always, presented with statistical uncertainty. This paper identifies five ways to [...] Read more.
Cost-effectiveness analyses of new cancer treatments in real-world settings (e.g., post-clinical trials) inform healthcare decision makers about their healthcare investments for patient populations. The results of these analyses are often, though not always, presented with statistical uncertainty. This paper identifies five ways to characterize statistical uncertainty: (1) a 95% confidence interval (CI) for the incremental cost-effectiveness ratio (ICER); (2) a 95% CI for the incremental net benefit (INB); (3) an INB by willingness-to-pay (WTP) plot; (4) a cost-effectiveness acceptability curve (CEAC); and (5) a cost-effectiveness scatterplot. It also explores their usage in 22 articles previously identified by a rapid review of real-world cost effectiveness of novel cancer treatments. Seventy-seven percent of these articles presented uncertainty results. The majority those papers (59%) used administrative data to inform their analyses while the remaining were conducted using models. Cost-effectiveness scatterplots were the most commonly used method (34.3%), with 40% indicating high levels of statistical uncertainty, suggesting the possibility of a qualitatively different result from the estimate given. Understanding the necessity for and the meaning of uncertainty in real-world cost-effectiveness analysis will strengthen knowledge translation efforts to improve patient outcomes in an efficient manner. Full article
(This article belongs to the Special Issue The Role of Real World Evidence in Oncology: Opportunities, Results and Limitations)
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12 pages, 1477 KiB  
Article
Utilization Trends of Novel Hormonal Agents in Metastatic Castration-Resistant Prostate Cancer in Quebec
by Jason Hu, Armen G. Aprikian, Ramy R. Saleh and Alice Dragomir
Curr. Oncol. 2022, 29(11), 8626-8637; https://doi.org/10.3390/curroncol29110680 - 12 Nov 2022
Cited by 2 | Viewed by 1795
Abstract
Background: The introduction of novel hormonal agents (NHAs) such as abiraterone acetate (ABI) and enzalutamide (ENZ) for metastatic castration-resistant prostate cancer (mCRPC) was an important milestone given their survival benefits, tolerability, and ease of administration relative to taxane chemotherapies. This descriptive study sought [...] Read more.
Background: The introduction of novel hormonal agents (NHAs) such as abiraterone acetate (ABI) and enzalutamide (ENZ) for metastatic castration-resistant prostate cancer (mCRPC) was an important milestone given their survival benefits, tolerability, and ease of administration relative to taxane chemotherapies. This descriptive study sought to describe the utilization trends of ABI and ENZ in patients with mCRPC in the early years after their approval in the province of Quebec in Canada. Methods: A retrospective population-based cohort was extracted from Quebec public healthcare administrative databases. The cohort included first-time users of NHAs (ABI or ENZ) from 2011 to 2016. The primary analyses aimed to describe the overall temporal trends (2011–2016) of NHA initiators by chemotherapy status (chemotherapy-naïve versus post-chemotherapy), and prescribing specialty (medical oncology versus urology versus others). Results: The cohort comprised 2183 patients, with 1562 (72%) in the chemotherapy-naïve group and 621 (28%) in the post-chemotherapy group. While the majority of patients were post-chemotherapy NHA initiators in 2012, this proportion decreased over time and accounted for only 13% of NHA initiators by the end of 2016. Medical oncologists were the most frequent prescribers of NHAs (upwards of 60%) throughout 2012 but fell to 45% by the end of 2016. Conversely, the proportion of prescriptions by urologists increased from 22% in 2012 to 42% in 2016. Conclusion: Over time, there was an increasing proportion of (1) patients who initiated NHAs without prior chemotherapy treatment, (2) NHA prescribing by urologists, and (3) ENZ users. Taken together, this implies that the introduction of NHAs has altered the management of mCRPC and urologists quickly adopted NHAs into their practice. Full article
(This article belongs to the Special Issue The Role of Real World Evidence in Oncology: Opportunities, Results and Limitations)
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10 pages, 1793 KiB  
Article
Using Real-World Data to Determine Health System Costs of Ontario Women Screened for Breast Cancer
by Nicole Mittmann, Soo Jin Seung, Christina Diong, Jodi M. Gatley, Michael Wolfson, Marie-Hélène Guertin, Nora Pashayan, Jacques Simard and Anna M. Chiarelli
Curr. Oncol. 2022, 29(11), 8330-8339; https://doi.org/10.3390/curroncol29110657 - 31 Oct 2022
Viewed by 1850
Abstract
Our study was to determine breast cancer screening costs in Ontario, Canada for screenings conducted through a formal (Ontario Breast Screening Program, OBSP) and informal (non-OBSP) screening program using administrative databases. Included women were 49–74 years of age when receiving screening mammograms between [...] Read more.
Our study was to determine breast cancer screening costs in Ontario, Canada for screenings conducted through a formal (Ontario Breast Screening Program, OBSP) and informal (non-OBSP) screening program using administrative databases. Included women were 49–74 years of age when receiving screening mammograms between 1 January 2013 to 31 December 2019. Each woman was followed for a screening episode with screening and diagnostic components, and costs were calculated as an average cost per woman per month in 2021 Canadian dollars. The final cohort of 1,546,386 women screened had a mean age of 59.4 ± 7.1 years and ~87% were screened via OBSP. The average total cost per woman per month was $136 ± $103, $134 ± $103 and $155 ± $104 for the entire, OBSP and non-OBSP cohorts, respectively. This was further disaggregated into the average total screening cost per month, which was $103 ± $8, $100 ± $4 and $117 ± $9 per woman, and the average total diagnostic cost per woman per month at $219 ± $166, $228 ± $165 and $178 ± $159. for the entire, OBSP and non-OBSP cohorts, respectively. These results indicate similar screening costs across the different cohorts, but higher diagnostic costs for the OBSP cohort. Full article
(This article belongs to the Special Issue The Role of Real World Evidence in Oncology: Opportunities, Results and Limitations)
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Review

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12 pages, 535 KiB  
Review
Impact of Regulatory Approval Status on CADTH Reimbursement of Oncology Drugs and Role of Real-World Evidence on Conditional Approvals from 2019 to 2021
by Catherine Lau and George Dranitsaris
Curr. Oncol. 2022, 29(11), 8031-8042; https://doi.org/10.3390/curroncol29110635 - 26 Oct 2022
Cited by 4 | Viewed by 2369
Abstract
Real-world evidence (RWE) is health and outcomes data generated from a patient’s journey through the health care system or disease process (i.e., real-world data). RWE is now having an increasingly important role in regulatory/reimbursement decisions. This article examines reimbursement recommendations by the Canadian [...] Read more.
Real-world evidence (RWE) is health and outcomes data generated from a patient’s journey through the health care system or disease process (i.e., real-world data). RWE is now having an increasingly important role in regulatory/reimbursement decisions. This article examines reimbursement recommendations by the Canadian Agency for Drugs and Technology in Health (CADTH) on oncology drugs approved between 2019 and 2021. Oncology drugs with a Summary Basis of Decision (SBD) for original marketing approvals were used to generate a corresponding list of CADTH final clinical recommendations for review. Of the 45 oncology drugs approved by Health Canada, CADTH granted positive funding recommendations to all 11 drugs that had priority review approvals. Two of the 17 drugs with standard reviews did not file to CADTH and 3 received a negative recommendation. Of the 17 drugs with Notice of Compliance with Conditions (NOCc) status, three were not filed to CADTH and four were under active reviews. Of the ten completed NOCc reviews, all contained RWE from sponsors and six received a negative decision on their first review. No significant differences in review times were found between the three approval statuses. Regulatory approval status appeared to influence reimbursement outcomes in Canada and evaluation of 10 NOCc approvals provided little insight regarding robustness of RWE required for more favorable considerations. Full article
(This article belongs to the Special Issue The Role of Real World Evidence in Oncology: Opportunities, Results and Limitations)
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