Publications

Search our bibliography using the filters on the right-hand side.

Displaying 1 through 50 of 53 publications.

Paller AS, Siegfried EC, Marron SE, Clark M, Harris N, Kosa K, Qin S, Whalley D, Chao J, Bansal A, Chuang CC, Wang Z. Skin pain and sleep quality numeric rating scales for children aged 6 months to 5 years with atopic dermatitis. J Eur Acad Dermatol Venereol. 2024 Jun 29. doi: 10.1111/jdv.20199

Paller AS, Siegfried E, Marron SE, Clark M, DiBenedetti D, Nelson L, Chao J, Bansal A, Chuang CC, Wang Z. Development and validation of a caregiver-reported NumericRating Scale for measuring worst scratch/itch in patients aged 6 months to younger than 6 years with atopic dermatitis. J Am Acad Dermatol. 2024 Feb;90(2):382-5. doi: 10.1016/j.jaad.2023.08.104

Williams V, Romano (DeMuro) C, Clark M, Korver D, Williams N, Goss D, Naujoks C, Marvel J. Psychometric evaluation of an electronic Asthma Symptom Diary for young children. J Patient Rep Outcomes. 2023 Oct 30;7(1):105. doi: 10.1186/s41687-023-00647-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

Khan AH, Kosa K, De Prado Gomez L, Whalley D, Kamat S, Clark M. Content validation of patient-reported sleep measures and development of a conceptual model of sleep disturbance in patients with moderate-to-severe, uncontrolled asthma. Patient Relat Outcome Meas. 2023 Mar 23;14:57-71. doi: 10.2147/PROM.S392666

Williams V, Romano (DeMuro) C, Clark M, Goss D, Naujoks C, Marvel J. Psychometric evaluation of a new electronic pediatric asthma symptom diary. Poster presented at the ISPOR Europe 2022; November 8, 2022. Vienna, Austria. [abstract] Value Health. 2022 Dec 1; 25(12):S428. doi: 10.1016/j.jval.2022.09.2130

Marvel J, Goransson O, Clark M, Romano (DeMuro) C, Olayinka-Amao O, Whalley D, Crawford R, Brindicci C, Garg K, Kordy K, Everhard F, Patalano F, Roesler Z, Landles R, Naujoks C, Gutzwiller FS. Interactive tablet application for self-report of asthma symptoms and impacts in young children. Poster presented at the ERS International Congress 2022; September 6, 2022. Barcelona, Spain. [abstract] Eur Respir J. 2022 Sep 4; 60(Suppl 66):2127. doi: 10.1183/13993003.congress-2022.2127

Paller A, Siegried E, Marron SE, Clark M, Kosa K, Whalley D, Chao J, Bansal A, Sun Y, Chuang C, Wang Z. Development and validation of a caregiver-reported numeric rating scale for measuring sleep quality in children aged 6 months to <6 years with atopic dermatitis. Poster presented at the 2022 Society for Investigative Dermatology (SID) Annual Meeting; May 19, 2022. Portland, OR. [abstract] J Invest Dermatol. 2022 Aug; 142(8 supplement):S42. doi: 10.1016/j.jid.2022.05.256

Paller A, Siegfried E, Marron SE, Clark M, DiBenedetti D, Nelson L, Chao J, Bansal A, Sun Y, Chuang C, Wang Z. Development and validation of a caregiver-reported numeric rating scale for measuring pruritus in children aged 6 months to <6 years with atopic dermatitis. Poster presented at the 2022 Society for Investigative Dermatology (SID) Annual Meeting; May 2022. Portland, OR. [abstract] J Invest Dermatol. 2022 Aug; 142(8 supplement):S25. doi: 10.1016/j.jid.2022.05.154

Paller A, Siegfried E, Marron SE, Clark M, Harris N, Quin S, Chao J, Bansal A, Sun Y, Chuang C, Wang Z. Development and validation of a caregiver reported numeric rating scale for measuring skin pain in children aged 6 months to 5 years with atopic dermatitis. Poster presented at the 2022 Society for Investigative Dermatology (SID) Annual Meeting; May 19, 2022. Portland, OR. [abstract] J Invest Dermatol. 2022 Aug 1; 142(8 supplement):S42. doi: 10.1016/j.jid.2022.05.257

Paller A, Siegfried E, Marron SE, Clark M, Kosa K, Whalley D, Chao J, Bansal A, Chuang CC, Wang Z. Development and validation of a caregiver-reported numeric rating scale for measuring sleep quality in children aged 6 months to 5 years with atopic dermatitis. Poster presented at the 2022 Society for Investigative Dermatology (SID) Annual Meeting; May 2022. Portland, OR.

Paller A, Siegfried E, Marron SE, Clark M, Harris N, Qin S, Chao J, Bansal A, Chuang CC, Wang Z. Development and validation of a caregiver-reported numeric rating scale for measuring skin pain in children (aged 6 months to 5 years) with atopic dermatitis. Poster presented at the 2022 Society for Investigative Dermatology (SID) Annual Meeting; May 2022. Portland, OR.

Clark M, Romano C, Olayinka-Amao O, Whalley D, Crawford R, Pathak P, Brindicci C, Garg K, Kordy K, Everhard F, Patalano F, Roesler Z, Sutton T, Goransson O, Landles R, Naujoks C, Marvel J, Keininger DL. Development and content validation of a self-completed, electronic Pediatric Asthma Symptom Diary. J Patient Rep Outcomes. 2022 Mar 20;6(1):25. doi: 10.1186/s41687-022-00432-3

Yosipovitch G, Reaney M, Mastey V, Eckert L, Abbe A, Nelson L, Clark M, Williams N, Chen Z, Ardeleanu M, Akinlade B, Graham NMH, Pirozzi G, Staudinger H, Plaum S, Radin A, Gadkari A. Peak Pruritus Numerical Rating Scale: psychometric validation and responder definition for assessing itch in moderate-to-severe atopic dermatitis. Br J Dermatol. 2019 Oct;181(4):761-9. doi: 10.1111/bjd.17744

Harrington M, Hareendran A, Skalicky A, Wilson H, Clark M, Mikl J. Assessing the impact on caregivers caring for patients with rare pediatric lysosomal storage diseases: development of the Caregiver Impact Questionnaire. J Patient Rep Outcomes. 2019 Jul 23;3(1):44. doi: 10.1186/s41687-019-0140-3

Clark M, Berry P, Martin S, Harris N, Sprecher D, Olitsky S, Hoag JB. Nosebleeds in hereditary hemorrhagic telangiectasia: development of a patient-completed daily eDiary. Laryngoscope Investig Otolaryngol. 2018 Nov 14;3(6):439-45. doi: 10.1002/lio2.211

Yosipovitch G, Reaney M, Eckert L, Nelson L, Clark M, Ardeleanu M, Radin A, Gadkari A. Validation of the peak pruritus numerical rating scale: results from clinical studies of dupilumab in adult patients with moderate-to-severe atopic dermatitis. Poster presented at the 9th World Congress on Itch; October 2017. Wroclaw, Poland.

Clark M, Schwedt TJ, Tepper SJ, Harris N, Martin S, Sapra S, Shah N. Patient satisfaction with prophylactic migraine medications. Poster presented at the 59th Annual Scientific Meeting American Headache Society; June 2017. Boston, MA. [abstract] Headache. 2017 Jun; 57(Suppl S3):133.

Yosipovitch G, Reaney M, Mastey V, Eckert L, Nelson L, Clark M, Abbe A, Ardeleanu M, Radin A, Gadkari A. Validation of the peak pruritus numerical rating scale: results from clinical studies of dupilumab in adults with moderate-to-severe atopic dermatitis. Poster presented at the 2017 American Academy of Dermatology Annual Meeting; March 4, 2017. Orlando, FL. [abstract] J Am Acad Dermatol. 2017 Jun; 76(6 Suppl 1):AB278. doi: 10.1016/j.jaad.2017.04.1082

Yosipovitch G, Reaney M, Eckert L, Nelson L, Clark M, Abbe A, Ardeleanu M, Radin A, Gadkari A. Validation of the peak pruritus numerical rating scale: results from clinical studies of dupilumab in adults with moderate-to-severe atopic dermatitis. Poster presented at the Australasian College of Dermatologists 50th Annual Scientific Meeting; May 2017. Sydney, Australia. [abstract] Australas J Dermatol. 2017 May; 58(S1):106-7. Previously presented at the 2017 American Academy of Dermatology Annual Meeting. doi: 10.1111/ajd.21_12652

Copley-Merriman C, Zelt S, Clark M, Gnanasakthy A. Impact of measuring patient-reported outcomes in dermatology drug development. Patient. 2017 Apr;10(2):203-13. doi: 10.1007/s40271-016-0196-6

Clark M, DiBenedetti D, Perez V. Cognitive dysfunction and work productivity in major depressive disorder. Expert Rev Pharmacoecon Outcomes Res. 2016 Jun 8. doi: 10.1080/14737167.2016.1195688

Gnanasakthy A, DeMuro C, Clark M, Haydysch E, Ma E, Bonthapally V. Patient-reported outcomes labeling for products approved by the office of hematology and oncology products of the US Food and Drug Administration (2010-2014). J Clin Oncol. 2016 Jun 1;34(16):1928-34. doi: 10.1200/JCO.2015.63.6480

Clark M, Harris NI, Martin S, Bartley K, DeBusk K, Abidoye O, Shore N. The impact of non-muscle invasive bladder cancer: qualitative research with patients. Poster presented at the 2015 ISPOR 18th Annual European Congress; November 2015. Milan, Italy.

Copley-Merriman C, Zelt S, Clark M, Gnanasakthy A. Benefits of patient-reported outcomes in dermatology drug development. Poster presented at the 2015 ISPOR 20th Annual International Meeting; May 2015. Philadelphia, PA.

Clark M, Martin S, Svedsater H, Dale P, Jacques L. Measurement properties of an asthma symptom and rescue medication use diary. J Asthma. 2015 Feb;52(1):88-97. doi: 10.3109/02770903.2014.947430

Clark MJ, Harris N, Griebsch I, Kaschinski D, Copley-Merriman C. Patient-reported outcome labeling claims and measurement approach for metastatic castration-resistant prostate cancer treatments in the United States and European Union. Health Qual Life Outcomes. 2014 Jul 4;12(1):104.

Clark MJ, Simons C, Haydysch EE, DeMuro-Mercon CJ, Gnanasakthy A. A review of patient-reported outcome orphan drug labels in the United States from January 2006-September 2013: analysis of evidence for orphan drug PRO label claims. Poster presented at the 2014 ISPOR 19th Annual International Meeting; June 3, 2014.

DeMuro C, Clark M, Doward L, Evans E, Mordin M, Gnanasakthy A. Assessment of PRO label claims granted by the FDA as compared to the EMA (2006–2010). Value Health. 2013 Dec;16(8):1150-5. doi: 10.1016/j.jval.2013.08.2293

Barrett AM, Clark MJ, DeMuro C, Esser D. Proxy-reported questionnaires for young children with asthma: a structured review. Eur Respir J. 2013 Aug 1;42(2):513-26.

Gnanasakthy A, Lewis S, Clark M, Mordin M, DeMuro C. Potential of patient-reported outcomes as nonprimary endpoints in clinical trials. Health Qual Life Outcomes. 2013 May 15;11:83.

Gnanasakthy A, DeMuro-Mercon CJ, Clark MJ, Mordin MM, Thomas S. Role of patient-reported outcome measures in the assessment of central nervous system agents. Ther Innov Regul Sci. 2013;47(5):613-8.

Gnanasakthy A, Doward L, Clark M, Mordin M, DeMuro C. Concordance of pro labeling claims between the FDA and EMA. Poster presented at the 2012 ISPOR 15th Annual European Congress; November 9, 2012. Berlin, Germany. [abstract] Value Health. 2012 Nov; 15(7):A321.

Mordin M, Clark M, Doward L, Willian M. Pediatric patient-reported outcomes assessment: a case study in epidermolysis bullosa. Poster presented at the 2012 ISPOR 15th Annual European Congress; November 9, 2012. Berlin, Germany. [abstract] Value Health. 2012 Nov; 15(7):A480-1.

Gnanasakthy A, Lewis SA, Clark MJ, Mordin MM, Evans E, DeMuro-Mercon CJ. The impact of primary endpoints on patient-reported outcome label claims. Poster presented at the 2012 ISPOR 17th Annual International Meeting; June 2012.

DeMuro C, Clark M, Coon C, Evans E, Mordin M, Gnanasakthy A. Assessment of PRO labels claims granted by the FDA as compared to the EMA. Poster presented at the 2012 ISPOR 17th Annual International Meeting; June 2012. Washington, DC. [abstract] Value Health. 2012 Jun; 15(4):A201. doi: 10.1016/j.jval.2012.03.1085

Gnanasakthy A, Lewis S, Clark M, Evans E, Mordin M, DeMuro C. Reported outcomes as primary endpoints in confirmatory clinical trials. Poster presented at the 2012 ISPOR 17th Annual International Meeting; June 2012. Washington, DC. [abstract] Value Health. 2012 Jun; 15(4):A200.

DeMuro C, Clark M, Mordin M, Fehnel S, Copley-Merriman C, Gnanasakthy A. Reasons for rejection of patient-reported outcome label claims: a compilation based on a review of patient-reported outcome use among new molecular entities and niologic license applications, 2006-2010. Value Health. 2012 May 1;15(3):443-8.

Gnanasakthy A, Mordin M, Clark M, DeMuro C, Fehnel S, Copley-Merriman C. A review of patient-reported outcome labels in the United States: 2006 to 2010. Value Health. 2012 May;15(3):437-42. doi: 10.1016/j.jval.2011.11.032

Clark M, Hofmann A, Tabberer M, Martin S. Development and content validity of the COPD device preference questionnaire. Poster presented at the 2011 ISPOR 14th Annual European Congress; November 9, 2011. [abstract] Value Health. 2011 Nov; 14(7):A255.

Mordin M, Clark M, DeMuro C, Evans ED, Copley-Merriman K, Fehnel S, Gnanasakthy A. Pro label claims: an analysis based on a review of pros among new molecular entities and biologic license applications 2006-2010. Poster presented at the 2011 ISPOR 16th Annual International Meeting; June 3, 2011. [abstract] Value Health. 2011 May; 14(3):A29.

Arbuckle R, Clark M, Harness J, Bonner N, Scott J, Draelos Z, Rizer R, Yeh Y, Copley-Merriman K. Item reduction and psychometric validation of the oily skin self assessment scale (OSSAS) and the oily skin impact scale (OSIS). Value Health. 2009 Jul 1;12(5):828-37.

Mordin MM, Clark M, Siersma CA, Copley-Merriman K, Gnanasakthy A. Impact of the FDA draft guidance on patient reported outcomes (PRO) label claims for approved drug products in the US: has it made a difference? Poster presented at the International Society for Pharmacoeconomics and Outcomes Research 14th Annual International Meeting; May 19, 2009. Orlando, FL. [abstract] Value Health. 2009 May; 12(3):A29.

Arbuckle R, Atkinson M, Clark MJ, Abetz-Webb L, Lohs J, Kuhagen I, Harness J, Draelos Z, Thiboutot D, Blume-Paytavi U, Copley-Merriman K. Patient experiences with oily skin: the qualitative development of content for two new patient reported outcome questionnaires. Poster presented at the American Academy of Dermatology Meeting; March 1, 2009.

Harness J, Draelos Z, Thiboutot D, Blume-Paytavi U, Mamolo C, Arbuckle R, Atkinson M, Clark M, Abetz L, Lohs J, Kuhagen I, Copley-Merriman K. Patient experiences with oily skin: the development of two new patient- reported outcomes questionnaires. Presented at the Annual Meeting of the American Academy of Dermatology; March 2009. San Francisco, CA.

Mamolo C, Harness J, Arbuckle R, Bonner N, Clark MJ, Scott J, Copley-Merriman K. Psychometric validation of the oily skin self-assessment and the oily skin impact scale (OSIS). Poster presented at the American Academy of Dermatology Meeting; March 1, 2009.

Clark MJ. Obtaining a patient reported outcome label claim: what is it, how do you achieve it, and why is it helpful for a pharmaceutical company? Presented at the Patient Reported Outcomes graduate course at the University of Michigan College of Pharmacy; March 1, 2009.

Clark M. Reader seeks clarification on hand-foot skin reaction. Clin J Oncol Nurs. 2008 Jun 1;12(3):395.

Richards DA, Boehm KA, Waterhouse DM, Wagener DJ, Krishnamurthi SS, Rosemurgy A, Grove W, Macdonald K, Gulyas S, Clark MJ, Dasse KD. Gemcitabine plus CI-994 offers no advantage over gemcitabine alone in the treatment of patients with advanced pancreatic cancer: results of a phase II randomized, double-blind, placebo-controlled, multicenter study. Ann Oncol. 2006 Jul 1;17:1096-102.

Shah S, Sesti AM, Copley-Merriman K, Plante M. Quality of life terminology included in package inserts for US approved medications. Qual Life Res. 2003 Dec 1;12(8):1107-17.