Publications
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Displaying 1 through 17 of 17 publications.
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Roth CL, Shoemaker AH, Ervin C, Norcross L, Fehnel S, Huber C, Scimia C, Abuzzahab MJ. Patient- and caregiver-reported experiences of hunger, weight, and energy in acquired yypothalamic obesity before and during setmelanotide treatment. Poster presented at the Endocrine Society (ENDO) 2024; June 1, 2024. Boston, MA.
Slota C, Norcross L, Comerford E, Sasane M, Zheng Y, Gnanasakthy A. Critical comments by Food and Drug Administration Reviewers on patient-reported outcomes in Food and Drug Administration Regulatory Submissions (2018-2021) [Editor's Choice]. Value Health. 2024 Jun;27(6):755-66. doi: 10.1016/j.jval.2024.02.011
Comerford E, Norcross L, Sasane M, Zheng Y, Gnanasakthy A. Patient-reported outcome (PRO) data in oncology NDAs approved by the FDA (2018–2021): a review of criticism and concerns in comments from regulators. Poster presented at the National Comprehensive Cancer Network (NCCN) 2024 Annual Conference; April 5, 2024. Orlando, FL. [abstract] J Natl Compr Canc Netw. 2024 Apr 5; 22(2.5). doi: 10.6004/jnccn.2023.7146
Davis S, Edwards T, Norcross L, Fehnel S, Beaudet A, Eckart M, Fastenau J. Use of the National Cancer Institute Patient-Reported Outcomes version of the common terminology criteria for adverse events to assess treatment tolerability in pulmonary arterial hypertension: qualitative patient research findings in current and former users of oral selexipag. J Patient Rep Outcomes. 2023 Dec 18;7(1):134. doi: 10.1186/s41687-023-00673-w.
Gnanasakthy A, Norcross L, Fitzgerald K. Editorial - Assessment of patient-reported outcomes in industry-sponsored phase 1 oncology studies: considerations for translating theory into practice. Value Health. 2023 Jun 21;26(10):1440-3. doi: 10.1016/j.jval.2023.06.006
Osborne RH, Nelson L, Fehnel S, Williams N, Bender R, Ziemiecki R, Gymnopoulou E, De Paepe E, Vandendijck Y, Norcross L, Heijnen E, Ispas G, Comeaux C, Callendret B, Chan EKH, Scott JA. Evaluation of symptoms in respiratory syncytial virus infection in adults: psychometric evaluation of the respiratory infection intensity and impact questionnaire™ symptom scores. J Patient Rep Outcomes. 2023 Jun 1;7(1):51. doi: 10.1186/s41687-023-00593-9.
Edwards T, Norcross L, Fine J, Martin S, Coulouvrat C, Spears P, Herold CI, Ferrari G, Onwudiwe N. Side effects and impacts of extended adjuvant endocrine therapy: a qualitative study among women with HR+/HER2- breast cancer. Poster presented at the 2023 ASCO Annual Meeting; June 2, 2023. Chicago, IL. [abstract] J Clin Oncol. 2023 Jun; 41(Suppl 16):e12509. doi: 10.1200/JCO.2023.41.16_suppl.e12509
Gnanasakthy A, Levy C, Norcross L, Doward L, Winnette R. A review of labeling based on patient reported outcome endpoints for new oncology drugs approved by the European Medicines Agency (2017-2021). Value Health. 2023 Jun;26(6):893-901. doi: 10.1016/j.jval.2023.01.017
Ervin C, Norcross L, Mallya UG, Fehnel S, Mittleman RS, Webster M, Haqq AM, Haws RM. Interview-based patient- and caregiver-reported experiences of hunger and improved quality of life with setmelanotide treatment in bardet-biedl syndrome. Adv Ther. 2023 May;40(5):2394-411. doi: 10.1007/s12325-023-02443-y
Gnanasakthy A, Norcross L, Clark M, Fitzgerald K. A review of patient-reported outcome considerations in oncologic drug advisory committee meetings (2016-2021). JCO Oncol Pract. 2023 May;19(5):e745-62. doi: 10.1200/OP.22.00774
Gnanasakthy A, Qin S, Norcross L. Editorial - FDA guidance on selecting, developing, or modifying fit-for-purpose clinical outcome assessments: old wine in a new bottle? Patient. 2023 Jan. doi: 10.1007/s40271-022-00607-6
Gnanasakthy A, Norcross L, (Demuro) Romano C, Carson RT. A review of patient-reported outcome labeling of FDA-approved new drugs (2016-2020): counts, categories, and comprehensibility. Value Health. 2022 Apr;25(4):647-55. doi: 10.1016/j.jval.2021.10.006
Osborne R, Nelson L, Fehnel S, Williams N, Bender RH, Ziemiecki R, Gymnopoulou E, De Paepe E, Norcross L, Heijnen E, Ispas G, Cheret A, Comeaux C, Callendret B, Vandendijck Y, Chan E, Scott J. Measurement of symptoms in respiratory syncytial virus–infected adults: meaningful within-patient change thresholds for the respiratory infection intensity and impact questionnaire (RiiQ). Poster presented at the 8th ESWI Influenza Conference Scientific and SPI Virtual Programme; December 4, 2021.
Gnanasakthy A, Barrett A, Norcross L, D’Alessio D, Romano (DeMuro) C. Use of patient and investigator global impression scales: a review of Food and Drug Administration–approved labeling, 2009 to 2019. Value Health. 2021 Jul;24(7):1016-23. doi: 10.1016/j.jval.2021.01.005
Osborne RH, Nelson L, Elsworth GR, Fehnel S, Williams N, Bender RH, Ziemiecki R, Gymnopoulou E, De Paepe E, Norcross L, Heijnen E, Ispas G, Cheret A, Comeaux C, Chan E, Scott JA. Psychometric evaluation of the Respiratory Infection Intensity and Impact Questionnaire Version 2 (RiiQTMv2) symptom scores for respiratory syncytial virus. Poster presented at the Virtual ISPOR 2021 Conference; May 2021.
DuBrock HM, Nathan SD, Reeve BB, Kolaitis NA, Mathai SC, Classi PM, Nelsen AC, Olayinka-Amao B, Norcross LN, Martin SA. Pulmonary hypertension due to interstitial lung disease or chronic obstructive pulmonary disease: a patient experience study of symptoms and their impact on quality of life. Pulm Circ. 2021 Apr 1;11(2):204589402. doi: 10.1177/20458940211005641
Gnanasakthy A, Barrett A, D'Alessio D, Norcross L. Review of patient and clinician global assessments in PRO labeling (2017-2019). Poster presented at the ISPOR Virtual 2020 Conference; May 2020. [abstract] Value Health. 2020 May 1; 23(Suppl 1):S299. doi: 10.1016/j.jval.2020.04.094