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A. Gnanasakthy · SciRah

Researcher profile · Semantic Scholar

A. Gnanasakthy

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A. Gnanasakthy — researcher profile on SciRah

h-index: 27
Works: 120
Citations: 2,288

Most-cited papers

Patient reported outcomes: looking beyond the label claim
L. Doward, A. Gnanasakthy, M. Baker
2010Health and Quality of Life Outcomes153 citations Open access
Semantic Scholar
Patient-Reported Outcomes in Cancer Drug Development and US Regulatory Review: Perspectives From Industry, the Food and Drug Administration, and the Patient.
E. Basch, C. Geoghegan, S. Coons, A. Gnanasakthy +3 more
2015JAMA Oncology131 citations Open access
Semantic Scholar
A review of patient-reported outcome labels in the United States: 2006 to 2010.
A. Gnanasakthy, M. Mordin, M. Clark, C. Demuro +2 more
2012Value in Health119 citations Open access
Semantic Scholar
A Review of Patient-Reported Outcomes Labeling for Oncology Drugs Approved by the FDA and the EMA (2012-2016).
A. Gnanasakthy, Amy M. Barrett, E. Evans, D. D'Alessio +1 more
2019Value in Health97 citations Open access
Semantic Scholar
Conducting economic evaluations alongside multinational clinical trials: toward a research consensus.
S. Reed, K. Anstrom, A. Bakhai, A. Briggs +12 more
2005American Heart Journal97 citations
Semantic Scholar
Ethical Considerations for the Inclusion of Patient-Reported Outcomes in Clinical Research: The PRO Ethics Guidelines.
Samantha Cruz Rivera, O. Aiyegbusi, J. Ives, H. Draper +31 more
2022Journal of the American Medical Association (JAMA)77 citations Open access
Semantic Scholar
Patient-Reported Outcome Measures in Atopic Dermatitis and Chronic Hand Eczema in Adults
Amy M. Barrett, Julie Hahn-Pedersen, Nana Kragh, E. Evans +1 more
2019Patient75 citations Open access
Semantic Scholar
Assessment of PRO label claims granted by the FDA as compared to the EMA (2006-2010).
C. Demuro, M. Clark, L. Doward, E. Evans +2 more
2013Value in Health71 citations Open access
Semantic Scholar
Documenting the rationale and psychometric characteristics of patient reported outcomes for labeling and promotional claims: the PRO Evidence Dossier
D. Revicki, A. Gnanasakthy, K. Weinfurt
2007Quality of Life Research68 citations
Semantic Scholar
Psoriasis patients with psoriasis Area and Severity Index (PASI) 90 response achieve greater health-related quality-of-life improvements than those with PASI 75–89 response: results from two phase 3 studies of secukinumab
B. Elewski, L. Puig, M. Mordin, I. Gilloteau +5 more
2017Journal of dermatological treatment (Print)60 citations
Semantic Scholar
US FDA patient-reported outcome guidance: great expectations and unintended consequences
S. Fehnel, C. Demuro, L. McLeod, C. Coon +1 more
2013Expert review of pharmacoeconomics & outcomes research52 citations
Semantic Scholar
A Review of Patient-Reported Outcome Labeling in the United States (2011-2015).
A. Gnanasakthy, M. Mordin, E. Evans, L. Doward +1 more
2017Value in Health51 citations Open access
Semantic Scholar
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, C. Demuro, M. Clark, E. Haydysch +2 more
2016Journal of Clinical Oncology51 citations
Semantic Scholar
Psychometric evaluation of the Sheehan Disability Scale in adult patients with attention-deficit/hyperactivity disorder
Theresa M. Coles, C. Coon, C. Demuro, L. McLeod +1 more
2014Neuropsychiatric Disease and Treatment49 citations Open access
Semantic Scholar
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.
C. Demuro, M. Clark, M. Mordin, S. Fehnel +2 more
2012Value in Health48 citations Open access
Semantic Scholar
A Review of Patient-Reported Outcome Labeling of FDA-Approved New Drugs (2016-2020): Counts, Categories, and Comprehensibility.
A. Gnanasakthy, L. Norcross, Carla DeMuro Romano, Robyn T. Carson
2021Value in Health41 citations Open access
Semantic Scholar
Potential of patient-reported outcomes as nonprimary endpoints in clinical trials
A. Gnanasakthy, Sandra Lewis, M. Clark, M. Mordin +1 more
2013Health and Quality of Life Outcomes40 citations Open access
Semantic Scholar
Quality of life improvements following one year of setmelanotide in children and adult patients with Bardet–Biedl syndrome: phase 3 trial results
E. Forsythe, R. Haws, J. Argente, P. Beales +8 more
2023Orphanet Journal of Rare Diseases38 citations Open access
Semantic Scholar
Patient-Reported Outcomes, Patient-Reported Information
Mike Baldwin, A. Spong, L. Doward, A. Gnanasakthy
2011Patient36 citations Open access
Semantic Scholar
Measurement Equivalence of Patient-Reported Outcome Measures Migrated to Electronic Formats: A Review of Evidence and Recommendations for Clinical Trials and Bring Your Own Device
B. Byrom, C. Gwaltney, A. Slagle, A. Gnanasakthy +1 more
2019Therapeutic Innovation and Regulatory Science31 citations
Semantic Scholar
Quality of life outcomes in two phase 3 trials of setmelanotide in patients with obesity due to LEPR or POMC deficiency
P. Kühnen, M. Wabitsch, J. von Schnurbein, Costel Chirila +7 more
2022Orphanet Journal of Rare Diseases29 citations Open access
Semantic Scholar
Impact of Measuring Patient-Reported Outcomes in Dermatology Drug Development
C. Copley-Merriman, S. Zelt, M. Clark, A. Gnanasakthy
2017Patient27 citations
Semantic Scholar
Use of Patient and Investigator Global Impression Scales: A Review of Food and Drug Administration-Approved Labeling, 2009 to 2019.
A. Gnanasakthy, Amy M. Barrett, L. Norcross, D. D'Alessio +1 more
2021Value in Health25 citations Open access
Semantic Scholar
PRM96 - Methods for reporting the patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE) data in cancer clinical trials
A. Gnanasakthy, D. Eid, X. Zhou
201825 citations Open access
Semantic Scholar
Secukinumab sustains early patient‐reported outcome benefits through 1 year: Results from 2 phase III randomized placebo‐controlled clinical trials comparing secukinumab with etanercept
B. Strober, A. Gottlieb, B. Sherif, P. Mollon +7 more
2017Journal of American Academy of Dermatology22 citations
Semantic Scholar
Secukinumab treatment in rheumatoid arthritis is associated with incremental benefit in the clinical outcomes and HRQoL improvements that exceed minimally important thresholds
V. Strand, M. Kosinski, A. Gnanasakthy, U. Mallya +1 more
2014Health and Quality of Life Outcomes22 citations Open access
Semantic Scholar
Quality of Life in Organ Transplant Recipients Participating in an Online Transplant Community
P. Wicks, K. Sulham, A. Gnanasakthy
2013Patient22 citations Open access
Semantic Scholar
Development of the sporadic inclusion body myositis physical functioning assessment
C. Demuro, S. Lewis, L. Lowes, L. Alfano +2 more
2016Muscle and Nerve20 citations
Semantic Scholar
FDA Guidance on Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments: Old Wine in a New Bottle?
A. Gnanasakthy, S. Qin, L. Norcross
2022Patient18 citations Open access
Semantic Scholar
Capturing patients' perspectives of treatment in clinical trials/drug development.
A. Hareendran, A. Gnanasakthy, R. Winnette, D. Revicki
2012Contemporary Clinical Trials18 citations
Semantic Scholar
Assessing Changes in Chronic Spontaneous/Idiopathic Urticaria: Comparisons of Patient-Reported Outcomes Using Latent Growth Modeling
D. Stull, D. McBride, K. Houghton, A. Finlay +2 more
2016Advances in Therapy17 citations Open access
Semantic Scholar
A Review of Labeling based on PRO endpoints for new oncology drugs approved by the European Medicines Agency (2017-2021).
A. Gnanasakthy, Courtney Levy, L. Norcross, L. Doward +1 more
2023Value in Health16 citations
Semantic Scholar
Integration of patient-reported outcomes in multiregional confirmatory clinical trials
A. Gnanasakthy, C. Demuro, Caroline Boulton
2013Contemporary Clinical Trials16 citations Open access
Semantic Scholar
Psychometric validation of the Psoriasis Symptom Diary using Phase III study data from patients with chronic plaque psoriasis
B. Strober, Yang Zhao, M. Tran, A. Gnanasakthy +8 more
2016International Journal of Dermatology15 citations
Semantic Scholar
Efficacy of Canakinumab vs. triamcinolone acetonide according to multiple gouty arthritis‐related health outcomes measures
Jan D. Hirsch, A. Gnanasakthy, Rachel Lale, Kyle Choi +1 more
2014International journal of clinical practice14 citations Open access
Semantic Scholar
Urgency as an Endpoint in Irritable Bowel Syndrome
A. Mangel, Jian-Min Wang, B. Sherrill, A. Gnanasakthy +2 more
2011Gastroenterology Research12 citations Open access
Semantic Scholar
Psychometric validation of a patient‐reported measure of physical functioning in sporadic inclusion body myositis
Valerie Williams, Theresa M. Coles, A. Gnanasakthy, C. Demuro +5 more
2016Muscle and Nerve11 citations
Semantic Scholar
Health-Related Quality of Life, Symptoms, and Tolerability of Loncastuximab Tesirine in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma.
A. Spira, Xiaolei Zhou, Lei Chen, A. Gnanasakthy +6 more
2021Clinical Lymphoma, Myeloma & Leukemia10 citations Open access
Semantic Scholar
Health-related quality of life is maintained with ixazomib maintenance in post-transplant newly diagnosed multiple myeloma: the TOURMALINE-MM3 trial
M. Dimopoulos, H. Goldschmidt, V. Maisnar, I. Špička +9 more
2019Clinical Lymphoma, Myeloma & Leukemia10 citations
Semantic Scholar
Oncology clinical trials
W. Kelly, S. Halabi, C. Hudis, R. Schilsky +132 more
20139 citations
Semantic Scholar
Patient-Reported Quality of Life before and after Stopping Treatment in the ENESTop Trial of Treatment-Free Remission for Patients with Chronic Myeloid Leukemia in Chronic Phase
F. Mahon, C. Boquimpani, N. Takahashi, N. Benyamini +16 more
20168 citations
Semantic Scholar
A review of patient-reported outcome assessments in registration trials of FDA-approved new oncology drugs (2014-2018).
A. Gnanasakthy, Jon Russo, Kajan Gnanasakthy, N. Harris +1 more
2022Contemporary Clinical Trials7 citations
Semantic Scholar
Patient experiences with patient-reported outcome measures in metastatic breast cancer trials: qualitative interviews
C. Romano, N. Harris, A. Gnanasakthy, D. D'Alessio +1 more
2022Journal of Patient-Reported Outcomes6 citations Open access
Semantic Scholar
Role of Patient-Reported Outcome Measures in the Assessment of Central Nervous System Agents
A. Gnanasakthy, C. Demuro, M. Clark, M. Mordin +1 more
2013Therapeutic Innovation and Regulatory Science5 citations
Semantic Scholar
Patient-reported outcomes from two global multicenter clinical trials of children and adults with tropomyosin receptor kinase (TRK) fusion cancer receiving larotrectinib.
S. Kummar, L. Mascarenhas, B. Geoerger, B. Turpin +10 more
2019Journal of Clinical Oncology4 citations
Semantic Scholar
Conceptual Model and Instrument Review in Multiple Sclerosis
S. Martin, O. Olayinka-Amao, C. Henke, P. Kamudoni +1 more
20174 citations Open access
Semantic Scholar
Overcoming Organizational Challenges of Integrating Patient-Reported Outcomes in Oncology Clinical Trials
A. Gnanasakthy, C. Demuro
2015Therapeutic Innovation and Regulatory Science4 citations Open access
Semantic Scholar
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?
M. Mordin, M. Clark, C. Siersma, K. Copley-Merriman +1 more
20094 citations Open access
Semantic Scholar
Assessment of Patient-Reported Outcomes in Industry-Sponsored Phase 1 Oncology Studies: Considerations for Translating Theory Into Practice.
A. Gnanasakthy, L. Norcross, K. Fitzgerald
2023Value in Health3 citations
Semantic Scholar
Patient-Reported Outcomes in Latin America: Implementation in Research and Role in Emerging HTA Systems.
R. Winnette, V. Zárate, G. Machnicki, C. Demuro +2 more
2015Value in Health Regional Issues3 citations Open access
Semantic Scholar

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