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2. Effectively Leveraging RWD for External Controls: A Systematic Literature Review of Regulatory & HTA Decisions

Author

Sola‐Morales, Oriol, primary, Curtis, Lesley H., additional, Heidt, Julien, additional, Walsh, Laura, additional, Casso, Deborah, additional, Oliveria, Susan, additional, Saunders‐Hastings, Patrick, additional, Song, Yufei, additional, Mercado, Tiffany, additional, Zusterzeel, Robbert, additional, Mastey, Vera, additional, Harnett, James, additional, and Quek, Ruben G. W., additional

Published
2023
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3. Regulatory and HTA Considerations for Development of Real‐World Data Derived External Controls

Author

Curtis, Lesley H., primary, Sola‐Morales, Oriol, additional, Heidt, Julien, additional, Saunders‐Hastings, Patrick, additional, Walsh, Laura, additional, Casso, Deborah, additional, Oliveria, Susan, additional, Mercado, Tiffany, additional, Zusterzeel, Robbert, additional, Sobel, Rachel E., additional, Jalbert, Jessica J., additional, Mastey, Vera, additional, Harnett, James, additional, and Quek, Ruben G. W., additional

Published
2023
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4. Effectively Leveraging RWD for External Controls: A Systematic Literature Review of Regulatory and HTA Decisions.

Author

Sola‐Morales, Oriol, Curtis, Lesley H., Heidt, Julien, Walsh, Laura, Casso, Deborah, Oliveria, Susan, Saunders‐Hastings, Patrick, Song, Yufei, Mercado, Tiffany, Zusterzeel, Robbert, Mastey, Vera, Harnett, James, and Quek, Ruben G. W.

Subjects
INVESTIGATIONAL therapies, TECHNOLOGY assessment, MISSING data (Statistics), MEDICAL technology, VALIDITY of statistics
Abstract

Real‐world data (RWD)‐derived external controls can be used to contextualize efficacy findings for investigational therapies evaluated in uncontrolled trials. As the number of submissions to regulatory and health technology assessment (HTA) bodies using external controls rises, and in light of recent regulatory and HTA guidance on the appropriate use of RWD, there is a need to address the operational and methodological challenges impeding the quality of real‐world evidence (RWE) generation and the consistency in evaluation of RWE across agencies. This systematic review summarizes publicly available information on the use of external controls to contextualize outcomes from uncontrolled trials for all indications from January 1, 2015, through August 20, 2021, that were submitted to the European Medicines Agency, the US Food and Drug Administration, and/or select major HTA bodies (National Institute for Health and Care Excellence (NICE), Haute Autorité de Santé (HAS), Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG), and Gemeinsamer Bundesausschuss (G‐BA)). By systematically reviewing submissions to regulatory and HTA bodies in the context of recent guidance, this study provides quantitative and qualitative insights into how external control design and analytic choices may be viewed by different agencies in practice. The primary operational and methodological aspects identified for discussion include, but are not limited to, engagement of regulators and HTA bodies, approaches to handling missing data (a component of data quality), and selection of real‐world endpoints. Continued collaboration and guidance to address these and other aspects will inform and assist stakeholders attempting to generate evidence using external controls. [ABSTRACT FROM AUTHOR]

Published
2023
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6. Ivosidenib Improves Overall Survival Relative to Standard Therapies in Relapsed or Refractory Mutant IDH1 AML: Results from Matched Comparisons to Historical Controls

Author

Paschka, Peter, primary, Dombret, Hervé, additional, Thomas, Xavier, additional, Recher, Christian, additional, Chantepie, Sylvain, additional, Montesinos Fernandez, Pau, additional, Acuña-Cruz, Evelyn, additional, Vyas, Paresh, additional, Kreuzer, Karl-Anton, additional, Heuser, Michael, additional, Metzeler, Klaus H., additional, Dennis, Michael, additional, Quesnel, Bruno, additional, Hunault-Berger, Mathilde, additional, Mohty, Mohamad, additional, Pigneux, Arnaud, additional, De Botton, Stephane, additional, Weber, Daniela, additional, Döhner, Konstanze, additional, Milkovich, Gary, additional, Reitan, John, additional, MacDonald, Sarah C, additional, Casso, Deborah, additional, Storm, Michael, additional, Liu, Hua, additional, Kapsalis, Stephanie M., additional, Attar, Eyal C., additional, Winkler, Thomas, additional, and Döhner, Hartmut, additional

Published
2020
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12. Quality of life of 5–10 year breast cancer survivors diagnosed between age 40 and 49

Author

Taplin Stephen, Buist Diana SM, and Casso Deborah

Subjects
breast cancer, long-term survivors, quality of life, Computer applications to medicine. Medical informatics, R858-859.7
Abstract

Abstract Background The purpose of this report is to examine the correlates of quality of life (QOL) of a well-defined group of long-term breast cancer survivors diagnosed between the ages of 40 and 49. Methods Women were eligible if they were diagnosed with invasive breast cancer or ductal carcinoma in situ 5 to 10 years before June 30, 1998 and were enrolled at Group Health Cooperative, a health maintenance organization in western Washington State. A questionnaire was mailed to 290 women; 216 were included in this analysis. The questionnaire included standardized measures of QOL [e.g., the Cancer Rehabilitation Evaluation System (CARES-SF) and SF-36] as well as general demographic and medical information. ANOVA and logistic regression were used to estimate correlates of self-reported QOL. Results The mean age at diagnosis was 44.4 years, and the average time since diagnosis was 7.3 years. Women reported high levels of functioning across several standardized QOL scales; mild impairment was found on the CARES-SF Sexual Scale. The presence of breast-related symptoms at survey, use of adjuvant therapy, having lower income, and type of breast surgery were significantly associated with lower QOL 5 to 10 years post-diagnosis on one or more of the scales. Conclusions Our results emphasize that younger long-term survivors of breast cancer have a high QOL across several standardized measures. However, the long-term consequences of adjuvant therapy and the management of long-term breast-related symptoms are two areas that may be important for clinicians and women with breast cancer in understanding and optimizing long-term QOL.

Published
2004
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17. Treatment patterns, adherence, and persistence among psoriasis patients treated with biologics in a real-world setting, overall and by disease severity.

Author

Murage, Mwangi J., Anderson, Amanda, Casso, Deborah, Oliveria, Susan A., Ojeh, Clement K., Muram, Talia M., Merola, Joseph F., Zbrozek, Art, and Araujo, Andre B.

Subjects
PSORIASIS, PERSISTENCE, PATIENT compliance, BIOLOGICALS, NOSOLOGY
Abstract

Purpose: Describe treatment patterns by disease severity among biologic-treated psoriasis patients. Materials and methods: We selected our study cohort in the IQVIA PharMetrics Plus adjudicated claims database linked to Electronic Health Record data from Modernizing Medicine Data Services. Patients were classified as having mild, moderate, or severe psoriasis based on a hierarchy of available severity measures. Patients were followed for 360 days to assess combination therapy, therapy switching and restarting, adherence and persistence. Results: The cohort comprised 2130 biologic-treated patients (mean age: 47.6 years; 45.4% female); 447 (21%) had available disease severity measures. Compared to patients with mild (N = 282) psoriasis, more patients with moderate (N = 116) or severe (N = 49) disease used combination therapy (21.3% vs. 34.5% and 32.7%, respectively), switched therapies (12.1% vs. 19.8% and 22.4%), and discontinued biologics (18.4% vs. 27.6% and 36.7%). Mean adherence was <75% by Medication Possession Ratio (MPR) (73.9%) and Proportion of Days Covered (PDC) (70.2%). Overall, 52.2% had a mean MPR >80%. Mean persistence to biologics was 297.6 days. Persistence and adherence decreased with increasing disease severity. Conclusions: Biologic-treated psoriasis patients had inadequate adherence (i.e., MPR <80%) and modest persistence to biologics, with moderate and severe patients demonstrating lower adherence and persistence than mild patients. [ABSTRACT FROM AUTHOR]

Published
2019
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19. Quality of life of 5–10 year breast cancer survivors diagnosed between age 40 and 49

Author

Casso, Deborah, Buist, Diana SM, and Taplin, Stephen

Subjects
Adult, Washington, Psychometrics, Depression, Research, Carcinoma, Ductal, Breast, Age Factors, Breast Neoplasms, Middle Aged, lcsh:Computer applications to medicine. Medical informatics, humanities, Treatment Outcome, breast cancer, quality of life, Sickness Impact Profile, Surveys and Questionnaires, long-term survivors, Humans, Women's Health, lcsh:R858-859.7, Female, Survivors, Neoplasm Recurrence, Local, Factor Analysis, Statistical
Abstract

Background The purpose of this report is to examine the correlates of quality of life (QOL) of a well-defined group of long-term breast cancer survivors diagnosed between the ages of 40 and 49. Methods Women were eligible if they were diagnosed with invasive breast cancer or ductal carcinoma in situ 5 to 10 years before June 30, 1998 and were enrolled at Group Health Cooperative, a health maintenance organization in western Washington State. A questionnaire was mailed to 290 women; 216 were included in this analysis. The questionnaire included standardized measures of QOL [e.g., the Cancer Rehabilitation Evaluation System (CARES-SF) and SF-36] as well as general demographic and medical information. ANOVA and logistic regression were used to estimate correlates of self-reported QOL. Results The mean age at diagnosis was 44.4 years, and the average time since diagnosis was 7.3 years. Women reported high levels of functioning across several standardized QOL scales; mild impairment was found on the CARES-SF Sexual Scale. The presence of breast-related symptoms at survey, use of adjuvant therapy, having lower income, and type of breast surgery were significantly associated with lower QOL 5 to 10 years post-diagnosis on one or more of the scales. Conclusions Our results emphasize that younger long-term survivors of breast cancer have a high QOL across several standardized measures. However, the long-term consequences of adjuvant therapy and the management of long-term breast-related symptoms are two areas that may be important for clinicians and women with breast cancer in understanding and optimizing long-term QOL.

Published
2004

26. Ivosidenib Improves Overall Survival Relative to Standard Therapies in Relapsed or Refractory Mutant IDH1AML: Results from Matched Comparisons to Historical Controls

Author

Paschka, Peter, Dombret, Hervé, Thomas, Xavier, Recher, Christian, Chantepie, Sylvain, Montesinos Fernandez, Pau, Acuña-Cruz, Evelyn, Vyas, Paresh, Kreuzer, Karl-Anton, Heuser, Michael, Metzeler, Klaus H., Dennis, Michael, Quesnel, Bruno, Hunault-Berger, Mathilde, Mohty, Mohamad, Pigneux, Arnaud, De Botton, Stephane, Weber, Daniela, Döhner, Konstanze, Milkovich, Gary, Reitan, John, MacDonald, Sarah C, Casso, Deborah, Storm, Michael, Liu, Hua, Kapsalis, Stephanie M., Attar, Eyal C., Winkler, Thomas, and Döhner, Hartmut

Abstract

Background:A European Marketing Authorization Application for ivosidenib (IVO) is currently under review for the indication of mutant isocitrate dehydrogenase 1 (mIDH1) R132 relapsed/refractory (R/R) acute myeloid leukemia (AML) in adult patients (pts) who have received ≥ 2 prior regimens, including ≥ 1 standard intensive chemotherapy (IC) regimen, or are not candidates for IC and have received ≥ 1 prior non-intensive regimen. IVO is an oral, potent, targeted inhibitor of mIDH1and was approved by the FDA for the treatment of mIDH1R/R AML in 2018, and in newly diagnosed AML in adults ≥ 75 years of age or pts ineligible for IC in 2019, based on the results of the open-label AG120-C-001 (NCT02074839) study.

Published
2020
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