M. Clark

发表

Potential of patient-reported outcomes as nonprimary endpoints in clinical trials

A. Gnanasakthy, M. Mordin, S. Lewis, 2013, Health and Quality of Life Outcomes.

PHP97 PRO LABEL CLAIMS: AN ANALYSIS BASED ON A REVIEW OF PROS AMONG NEW MOLECULAR ENTITIES AND BIOLOGIC LICENSE APPLICATIONS 2006-2010

A. Gnanasakthy, M. Mordin, S. Fehnel, 2011 .

Patient-Reported Outcomes Labeling for Products Approved by the Office of Hematology and Oncology Products of the US Food and Drug Administration (2010-2014).

A. Gnanasakthy, M. Clark, C. Demuro, 2016, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

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 biologic license applications, 2006-2010.

A. Gnanasakthy, M. Mordin, C. Copley-Merriman, 2012, Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research.

Assessing the impact on caregivers caring for patients with rare pediatric lysosomal storage diseases: development of the Caregiver Impact Questionnaire

Magdalena Harrington, A. Hareendran, A. Skalicky, 2019, Journal of Patient-Reported Outcomes.

PHP96 REASONS FOR REJECTION OF PRO LABEL CLAIMS: AN ANALYSIS BASED ON A REVIEW OF PRO USE AMONG NEW MOLECULAR ENTITIES AND BIOLOGIC LICENSE APPLICATIONS 2006-2010

A. Gnanasakthy, M. Mordin, S. Fehnel, 2011 .

Item reduction and psychometric validation of the Oily Skin Self Assessment Scale (OSSAS) and the Oily Skin Impact Scale (OSIS).

Z. Draelos, Jane Scott, R. Arbuckle, 2009, Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research.

PRM111 Pediatric Patient-Reported Outcomes Assessment: A Case Study in Epidermolysis Bullosa

M. Mordin, L. Doward, M. Clark, 2012 .

Nosebleeds in hereditary hemorrhagic telangiectasia: Development of a patient‐completed daily eDiary

D. Sprecher, Susan A. Martin, P. Berry, 2018, Laryngoscope investigative otolaryngology.

Assessment of PRO label claims granted by the FDA as compared to the EMA (2006-2010).

Ari Gnanasakthy, Margaret Mordin, A. Gnanasakthy, 2013, Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research.

A review of patient-reported outcome labels in the United States: 2006 to 2010.

A. Gnanasakthy, M. Mordin, C. Copley-Merriman, 2012, Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research.

Development and content validation of a self-completed, electronic Pediatric Asthma Symptom Diary

D. Whalley, C. Naujoks, D. Keininger, 2022, Journal of Patient-Reported Outcomes.

Impact of Measuring Patient-Reported Outcomes in Dermatology Drug Development

A. Gnanasakthy, C. Copley-Merriman, M. Clark, 2017, The Patient - Patient-Centered Outcomes Research.

PMC55 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?

A. Gnanasakthy, M. Mordin, K. Copley-Merriman, 2009 .

Patient-reported outcome labeling claims and measurement approach for metastatic castration-resistant prostate cancer treatments in the United States and European Union

C. Copley-Merriman, I. Griebsch, M. Clark, 2014, Health and Quality of Life Outcomes.

Content Validation of Patient-Reported Sleep Measures and Development of a Conceptual Model of Sleep Disturbance in Patients with Moderate-to-Severe, Uncontrolled Asthma

D. Whalley, Asif H Khan, S. Kamat, 2023, Patient related outcome measures.

Measurement properties of an asthma symptom and rescue medication use diary

Susan A. Martin, L. Jacques, P. Dale, 2015, The Journal of asthma : official journal of the Association for the Care of Asthma.

Proxy-reported questionnaires for young children with asthma: a structured review

D. Esser, M. Clark, C. Demuro, 2012, European Respiratory Journal.

Cognitive dysfunction and work productivity in major depressive disorder

M. Clark, D. DiBenedetti, V. Perez, 2016, Expert review of pharmacoeconomics & outcomes research.

Role of Patient-Reported Outcome Measures in the Assessment of Central Nervous System Agents

Ari Gnanasakthy, Margaret Mordin, A. Gnanasakthy, 2013, Therapeutic innovation & regulatory science.