288 results on '"Gnanasakthy, Ari"'
Search Results
2. The Limitations of EQ-5D as a Clinical Outcome Assessment Tool
3. Advancing patient-centric care: integrating patient reported outcomes for tolerability assessment in early phase clinical trials – insights from an expert virtual roundtable
4. Critical Comments by Food and Drug Administration Reviewers on Patient-Reported Outcomes in Food and Drug Administration Regulatory Submissions (2018-2021)
5. Quality of life improvements following one year of setmelanotide in children and adult patients with Bardet–Biedl syndrome: phase 3 trial results
6. A Review of Labeling Based on Patient-Reported Outcome Endpoints for New Oncology Drugs Approved by the European Medicines Agency (2017-2021)
7. FDA Guidance on Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments: Old Wine in a New Bottle?
8. A Review of Patient-Reported Outcome Labeling of FDA-Approved New Drugs (2016-2020): Counts, Categories, and Comprehensibility
9. Health-Related Quality of Life, Symptoms, and Tolerability of Loncastuximab Tesirine in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
10. Quality of life outcomes in two phase 3 trials of setmelanotide in patients with obesity due to LEPR or POMC deficiency
11. Patient experiences with patient-reported outcome measures in metastatic breast cancer trials: qualitative interviews
12. Use of Patient and Investigator Global Impression Scales: A Review of Food and Drug Administration–Approved Labeling, 2009 to 2019
13. FDA Guidance on Assessment of Patient-Reported Outcomes in Cancer Trials: A Breath of Fresh Air or a Storm in a Teacup?
14. A Review of Patient-Reported Outcomes Labeling for Oncology Drugs Approved by the FDA and the EMA (2012-2016)
15. ABCL-316 Health-Related Quality of Life and Tolerability in Patients With/Without Skin Toxicity During Loncastuximab Tesirine Treatment in a Phase 2 Clinical Trial (LOTIS-2)
16. Patient-Reported Outcome Measures in Atopic Dermatitis and Chronic Hand Eczema in Adults
17. 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
18. Assessment of Patient-Reported Outcomes in Industry-Sponsored Phase I Oncology Studies: Considerations for Translating Theory Into Practice
19. Secukinumab sustains early patient-reported outcome benefits through 1 year: Results from 2 phase III randomized placebo-controlled clinical trials comparing secukinumab with etanercept
20. A Review of Patient-Reported Outcome Labeling in the United States (2011–2015)
21. Assessment of Patient-Reported Outcomes in Industry-Sponsored Clinical Trials
22. A Review of Patient-Reported Outcome Considerations in Oncologic Drugs Advisory Committee Meetings (2016-2021)
23. Patient-Reported Outcomes in Latin America: Implementation in Research and Role in Emerging HTA Systems
24. Impact of Measuring Patient-Reported Outcomes in Dermatology Drug Development
25. A Review of Labeling based on PRO endpoints for new oncology drugs approved by the European Medicines Agency (2017-2021)
26. FDA Guidance on Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments: Old Wine in a New Bottle?
27. Poster: ABCL-316 Health-Related Quality of Life and Tolerability in Patients With/Without Skin Toxicity During Loncastuximab Tesirine Treatment in a Phase 2 Clinical Trial (LOTIS-2)
28. A review of patient-reported outcome assessments in registration trials of FDA-approved new oncology drugs (2014–2018)
29. Assessment of PRO Label Claims Granted by the FDA as Compared to the EMA (2006–2010)
30. Integration of patient-reported outcomes in multiregional confirmatory clinical trials
31. Assessing Changes in Chronic Spontaneous/Idiopathic Urticaria: Comparisons of Patient-Reported Outcomes Using Latent Growth Modeling
32. Overcoming Organizational Challenges of Integrating Patient-Reported Outcomes in Oncology Clinical Trials
33. 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
34. A Review of Patient-Reported Outcome Labels in the United States: 2006 to 2010
35. Documenting the Rationale and Psychometric Characteristics of Patient Reported Outcomes for Labeling and Promotional Claims: The PRO Evidence Dossier
36. Ethical Considerations for the Inclusion of Patient-Reported Outcomes in Clinical Research
37. eP275: Quality of life in patients with Bardet-Biedl syndrome in a setmelanotide phase 3 trial
38. Promotion of Patient-Reported Outcome Label Claims Based on Nonprimary Endpoints
39. Quality of Life in Organ Transplant Recipients Participating in an Online Transplant Community
40. Psychometric validation of the Psoriasis Symptom Diary using Phase III study data from patients with chronic plaque psoriasis
41. Patient-Reported Outcomes in Cancer Drug Development and US Regulatory Review: Perspectives From Industry, the Food and Drug Administration, and the Patient
42. Role of Patient-Reported Outcome Measures in the Assessment of Central Nervous System Agents
43. Patient-Reported Outcomes, Patient-Reported Information: From Randomized Controlled Trials to the Social Web and Beyond
44. Conducting economic evaluations alongside multinational clinical trials: toward a research consensus
45. Multinational economic evaluation of valsartan in patients with chronic heart failure: results from the valsartan hear failure trial (Val-HeFT)
46. US FDA patient-reported outcome guidance: great expectations and unintended consequences
47. The Development of Standard Economic Datasets for use in the Economic Evaluation of Medicines
48. Potential Savings in the Cost of Caring for Alzheimer’s Disease: Treatment with Rivastigmine
49. Symptoms, Health-Related Quality of Life, and Tolerability of Loncastuximab Tesirine in Patients with Relapsed or Refractory Diffuse Large B Cell Lymphoma
50. Using Multiple Anchor- and Distribution-Based Estimates to Evaluate Clinically Meaningful Change on the Functional Assessment of Cancer Therapy-Biologic Response Modifiers (FACT-BRM) Instrument
Catalog
Books, media, physical & digital resources
Discovery Service for Jio Institute Digital Library
For full access to our library's resources, please sign in.