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» Authors » Rajeshwari Sridhara

Rajeshwari Sridhara

Explore the profile of Rajeshwari Sridhara including associated specialties, affiliations and a list of published articles. Areas
Snapshot
Articles 130
Citations 7911
Followers 0
Related Specialties
Oncology
Pharmacology
General Medicine
Top 10 Co-Authors
Richard Pazdur
Shenghui Tang
Julia A Beaver
Paul G Kluetz
Amna Ibrahim
Robert Justice
Patricia Keegan
Kirsten B Goldberg
Laleh Amiri-Kordestani
Gideon M Blumenthal
Published In
Clin Cancer Res
Oncologist
J Clin Oncol
Ther Innov Regul Sci
Lancet Oncol
Affiliations
Soon will be listed here.
Recent Articles
1.
Reflections and Roadmaps: Career Development beyond the FDA-AACR Oncology Educational Fellowship
Patel T, Chen C, Al Hadidi S, Kadry Y, Sridhara R, Purcell E, et al.
Clin Cancer Res . 2024 Jun; 30(15):3144-3146. PMID: 38856702
In 2020, the FDA's Oncology Center of Excellence, in collaboration with the American Association for Cancer Research, launched a novel educational partnership known as the FDA-AACR Oncology Educational Fellowship. This...
2.
A Pooled Analysis of Treatment-Free Survival in Advanced Renal Cell Carcinoma
Chang E, Zhou J, Song C, Gittleman H, Fernandes L, Weinstock C, et al.
Clin Cancer Res . 2024 Feb; 30(15):3282-3286. PMID: 38416426
Purpose: A clinically meaningful attribute of some immune-oncology (IO) regimens is potential durable clinical benefit during a treatment-free interval. We characterize treatment-free survival (TFS) with and without ongoing toxicity in...
3.
FDA Oncology Center of Excellence Crowdsourcing Initiative: Outreach to the Scientific Community to Identify Research Questions for Pooled Analyses of Oncology Clinical Trial Data
Schneider J, Eckstein J, Goldberg K, Ascione M, Bailey T, Taylor K, et al.
Clin Cancer Res . 2023 Apr; 29(16):2964-2972. PMID: 37011149
The FDA Oncology Center of Excellence recently launched a crowdsourcing pilot to request ideas from the scientific community for research questions that FDA could address with pooled analyses of clinical...
4.
The Association Between Baseline Hepatic or Renal Function and Clinical Outcomes for Patients With Non-Small Cell Lung Cancer Treated With a PD-1/PD-L1 Blocking Antibody Using Real-World and Trial Data
Liu Q, Mathur R, Xu Y, Torres A, Miksad R, Liu C, et al.
Clin Pharmacol Ther . 2023 Feb; 113(5):1139-1149. PMID: 36790088
Clinical trials have demonstrated the benefit of PD-1/PD-L1 blocking antibodies for the treatment of patients with advanced non-small cell lung cancer (NSCLC) in defined patient populations that often exclude patients...
5.
Improving Dose-Optimization Processes Used in Oncology Drug Development to Minimize Toxicity and Maximize Benefit to Patients
Fourie Zirkelbach J, Shah M, Vallejo J, Cheng J, Ayyoub A, Liu J, et al.
J Clin Oncol . 2022 Sep; 40(30):3489-3500. PMID: 36095296
This review highlights strategies to integrate dose optimization into premarketing drug development and discusses the underlying statistical principles. Poor dose optimization can have negative consequences for patients, most commonly because...
6.
Exploring the Potential of External Control Arms created from Patient Level Data: A case study in non-small cell lung cancer
Yin X, Mishra-Kalyan P, Sridhara R, Stewart M, Stuart E, Davi R
J Biopharm Stat . 2022 Jan; 32(1):204-218. PMID: 34986069
Randomized controlled trials (RCTs) are the gold standard for evaluation of new medical products. However, RCTs may not always be ethical or feasible. In cases where the investigational product is...
7.
Response Rate, Event-Free Survival, and Overall Survival in Newly Diagnosed Acute Myeloid Leukemia: US Food and Drug Administration Trial-Level and Patient-Level Analyses
Norsworthy K, Gao X, Ko C, Pulte E, Zhou J, Gong Y, et al.
J Clin Oncol . 2021 Dec; 40(8):847-854. PMID: 34890212
Purpose: To explore trial-level and patient-level associations between response (complete remission [CR] and CR + CR with incomplete hematologic [CRi] or platelet [CRp] recovery), event-free survival (EFS), and overall survival...
8.
Overall survival in patients with hormone receptor-positive, HER2-negative, advanced or metastatic breast cancer treated with a cyclin-dependent kinase 4/6 inhibitor plus fulvestrant: a US Food and Drug Administration pooled analysis
Gao J, Cheng J, Prowell T, Bloomquist E, Tang S, Wedam S, et al.
Lancet Oncol . 2021 Oct; 22(11):1573-1581. PMID: 34656225
Background: Cyclin-dependent kinase 4/6 inhibitors (CDKIs) are oral targeted agents approved for use in combination with endocrine therapy as first-line or second-line treatment of patients with hormone receptor-positive, HER2-negative, advanced...
9.
Does Knowledge of Treatment Assignment Affect Patient Report of Symptoms, Function, and Health Status? An Evaluation Using Multiple Myeloma Trials
Roydhouse J, Mishra-Kalyani P, Bhatnagar V, Gutman R, King-Kallimanis B, Sridhara R, et al.
Value Health . 2021 Jun; 24(6):822-829. PMID: 34119080
Objectives: Unblinded trials are common in oncology, but patient knowledge of treatment assignment may bias response to questionnaires. We sought to ascertain the extent of possible bias arising from patient...
10.
Subgroup Analyses in Oncology Trials: Regulatory Considerations and Case Examples
Amatya A, Fiero M, Bloomquist E, Sinha A, Lemery S, Singh H, et al.
Clin Cancer Res . 2021 Jun; 27(21):5753-5756. PMID: 34117032
Subgroup analyses are assessments of treatment effects based on certain patient characteristics out of the total study population and are important for interpretation of pivotal oncology trials. However, appropriate use...