Ari Gnanasakthy

RTI uses cookies to offer you the best experience online. By clicking “accept” on this website, you opt in and you agree to the use of cookies. If you would like to know more about how RTI uses cookies and how to manage them please view our Privacy Policy here. You can “opt out” or change your mind by visiting: http://optout.aboutads.info/. Click “accept” to agree.

Search Publications

Filter by Year

Filter by Publication Type

Search Results

The limitations of EQ-5D as a clinical outcome assessment tool

Critical comments by Food and Drug Administration reviewers on patient-reported outcomes in Food and Drug Administration regulatory submissions (2018-2021)

Recommendations to address respondent burden associated with patient-reported outcome assessment

Assessment of patient-reported outcomes in industry-sponsored phase I oncology studies: Considerations for translating theory into practice

A review of labeling based on patient-reported outcome endpoints for new oncology drugs approved by the European medicines agency (2017-2021)

Trends in the Inclusion of patient reported outcomes in oncology clinical trials: Analysis of clinicaltrials.gov (2013-2022)

A review of patient-reported outcome considerations in oncologic drugs advisory committee meetings (2016-2021)

Quality of life improvements following one year of setmelanotide in children and adult patients with Bardet-Biedl syndrome: Phase 3 trial results

FDA guidance on selecting, developing, or modifying fit-for-purpose clinical outcome assessments: Old wine in a new bottle?

Patient experiences with patient-reported outcome measures in metastatic breast cancer trials: qualitative interviews

ABCL-310 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)

A review of patient-reported outcome assessments in registration trials of FDA-approved new oncology drugs (2014-2018)

Ethical considerations for the inclusion of patient-reported outcomes in clinical research: The PRO ethics guidelines

A review of patient-reported outcome labeling of FDA-approved new drugs (2016-2020): Counts, categories, and comprehensibility

Health-related quality of life, symptoms, and tolerability of loncastuximab tesirine in patients with relapsed or refractory diffuse large B-cell lymphoma

Quality of life outcomes in two phase 3 trials of setmelanotide in patients with obesity due to LEPR or POMC deficiency

FDA guidance on assessment of patient-reported outcomes in cancer trials: A breath of fresh air or a storm in a teacup?

Use of patient and investigator global impression scales: A review of food and drug administration-approved labeling, 2009 to 2019

Symptoms, health-related quality of life, and tolerability of loncastuximab tesirine in patients with relapsed or refractory diffuse large b cell lymphoma

Real-world incidence and management of adverse events (AEs) in patients with non-metastatic castrate-resistant prostate cancer receiving apalutamide or enzalutamide