Publications by authors named "D Subramaniam"
: Women with late-stage metastatic breast cancer are at an increased risk of pain and distress from symptoms and often struggle with associated emotional and financial burden of their disease. Palliative care is known to alleviate symptom burden in patients with end-stage, terminal diseases but is often underutilized in both inpatient and outpatient settings. The current study aims to investigate the prevalence of palliative care consultation on inpatients with metastatic breast cancer and examine the association between palliative care consultation and length of hospital stay and total hospital charges.
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- Pregnant women with COVID-19 are at higher risk for severe outcomes, and this study evaluated the safety and effectiveness of the monoclonal antibody treatment CAS+IMD in this population.* -
- The study, which involved 82 pregnant participants, found that CAS+IMD was well tolerated with minimal adverse reactions, and it effectively reduced viral loads without significantly affecting fetal development.* -
- Overall, the treatment showed promising safety and efficacy, suggesting it could be a viable option for managing COVID-19 in pregnant women, although conclusions about its effects are limited due to a small number of placebo recipients.*
Article Synopsis
- A clinical trial assessed the safety of the combination of casirivimab and imdevimab (CAS + IMD) in children with COVID-19.
- The results showed that the treatment was well tolerated, similar to findings in adults, with minimal immune response side effects.
- The study supports further development of advanced monoclonal antibodies for children at higher risk for COVID-19.
Background: Single-arm clinical trials (SAT) are common in drug and biologic submissions for rare or life-threatening conditions, especially when no therapeutic options exist. External control arms (ECAs) improve interpretation of SATs but pose methodological and regulatory challenges.
Objective: Through narrative reviews and expert input, we developed a framework for considerations that might influence regulatory use and likelihood of regulatory acceptance of an SAT, identifying non-oncology first indication approvals as an area of interest.