Publications

Interpretation of surrogate endpoints in the era of the 21st Century Cures Act Intersections of efficacy, toxicity, and cost. Although surrogates may be used for legitimate reasons—such as aborting a trial if surrogates point in the wrong ... Michael Baum, MD, from University College London was the lead author. He was on OA academic advisory board at that time.....Read Article >>

Overuse and Misuse of Adjuvant Chemotherapy for Stages I and II Non-Small Cell Lung Cancer Chemotherapy: Empirical Findings from a Privately Insured Population Hrushesky WJM, Huff DFQ, Shimp WS, Bennett CL, Baranwal A, Knopf K, Bobolts LR,Armitage M, and Fishman M....Read Article >>

Generic oncology drugs: are they all safe? Y Tony Yang, Sumimasa Nagai, Brian K Chen, Zaina P Qureshi, Akida A Lebby, Samuel Kessler, Peter Georgantopoulos, Dennis W Raisch, Oliver Sartor, Terhi Hermanson, Robert C Kane, William J Hrushesky, Joshua J Riente, LeAnn B Norris, Laura R Bobolts, James O Armitage, Charles L Bennett ....Read Article >>

Adding Bevacizumab to the Treatment of Patients With Non–Small-Cell Lung Cancer: Caveat Emptor Terhi T.O. Hermanson, MD, PhD, William J. Hrushesky, MD, Kevin B. Knopf, MD, MPH, and Charles L. Bennett, MD, PhD, MPP. Adding Bevacizumab to the Treatment of Patients With Non–Small-Cell Lung Cancer: Caveat Emptor. Journal of Oncology Practice Publish Ahead of Print, published on August 4, 2015 as doi:10.1200/JOP.2015.005397. 2015, American Society of Clinical Oncology. Synopsis: Patient selection, Patterns of use, clinical toxicities, and hospitalizations associated with carboplatin, paclitaxel, and BEV (CPB) treatment administered to persons with stages IIB/IV non–smallcell lung cancer (NSCLC).....Read Article >>

Regulatory and clinical considerations for biosimilar oncology drugs Charles L Bennett, Brian Chen, Terhi Hermanson, Michael D Wyatt, Richard M Schulz, Peter Georgantopoulos, Samuel Kessler, Dennis W Raisch,Zaina P Qureshi, Z Kevin Lu, Bryan L Love, Virginia Noxon, Laura Bobolts, Melissa Armitage, John Bian, Paul Ray, Richard J Ablin,William J Hrushesky, Iain C Macdougall, Oliver Sartor, James O Armitage. Regulatory and clinical considerations for biosimilar oncology drugs. Lancet Oncology; vol 15; Dec. 2014. Synopsis: In this review, the only review paper on biosimilars not supported by the pharmaceutical industry, the regulatory frameworks, clinical experiences, an....Read Article >>

Overuse of five expensive oncology pharmaceuticals in the southeastern United States: A physician-level analysis. Bennett C, Huff D, Shimp W, Baranwal A, Mamgain A, Fishman M, Davis S, Kogler J, Schorer A, Bobolts L, Armitage M, Hrushesky W. Overuse of five expensive oncology pharmaceuticals in the southeastern United States: A physician-level analysis (Poster). 2014 ASCO Quality Care Symposium. Oct17 – 18, 2014. Boston, MA. Synopsis: OA monitors the overuse of the 5 most expensive cancer drugs prescribed by oncologists, and is implementing a three-tiered approach to addressing this problem.....Read Article >>

Are preclinical research findings replicable: An empirical analysis based on EpoR studies in cancer. Bennett CL, Kessler S, Schulz R, Chen B, Magwood J, Yenzen S, Norriz LB, Armitage J, Sartor O, Hrushesky WJM. Are preclinical research findings replicable: An empirical analysis based on EpoR studies in cancer. 2014 ASCO Annual Meeting (abstract). May 30-June 3, 2014, Chicago, IL. J Clin Oncol (Meeting Abstracts) May 2014 vol. 32 no. 15_suppl e17697 Synopsis: Preclinical EpoR research findings published by academic scientists differ from those by industry-employed scientists. ....Read Article >>

Systematic Approach to Pharmacovigilance beyond the Limits: The Southern Network on Adverse Reactions (SONAR) Projects Lu ZK, Samuel J Kessler BA, Schulz R, Bian J, Chen B, Wu J, Noxon V, Rao1 GA, Leibnitz R, Restaino J, Maxwell W, Norris LB, Qureshi ZP, Martin L, Love BL, Bookstaver B, Sutton S, Fayad R, Jacob S, Georgantopoulos P, Sartor O, Yarnold PR, Huff D, Hrushesky W, Raisch DW, Ablin R, Bennett CLB. Systematic Approach to Pharmacovigilance beyond the Limits: The Southern Network on Adverse Reactions (SONAR) Projects. Adv Pharmacoepidemiol Drug Saf. 2014 Apr 30; 3(2): 149. Synopsis: The Southern Network on Adverse Reactions (SONAR) team describes a systematic approach to decreasing the time between significan....Read Article >>

Adjuvant colon cancer care compliance with level I data and NCCN guidelines in the elderly population. Baranwal A, Huff DFQ, Fishman ML, Kogler J, Shimp WS, Bobolts LR, Fishman V, Armitage M, Davis S, Anthony C, Schorer AE, Bennett CL, Hrushesky WJM. Adjuvant colon cancer care compliance with level I data and NCCN guidelines in the elderly. 2014 ASCO Annual Meeting (abstract). May 30-June 3, 2014, Chicago, IL. J Clin Oncol (Meeting Abstracts) May 2014 vol. 32 no. 15_suppl e14520 Synopsis: The misuse of oxaliplatin adjuvant chemotherapy in elderly colon cancer patients results in OA launching a three-tiered effort to enhance cancer care. (more…)....Read Article >>

Adjuvant colon cancer care quality, risk, value, and level one data and guideline compliance among the elderly privately insured in southeastern USA. Hrushesky WJM, Baranwal A, Huff DF, Shimp WS, Mamgain A, Fishman M, Schorer AE, Bobolts LR, Davis S, Kogler J, Armitage M, Bennett CL. Adjuvant colon cancer care quality, risk, value and level one data & guideline compliance among the elderly privately insured in southeastern USA (Poster). 2014 ASCO Quality Care Symposium. Oct17 – 18, 2014. Boston, MA. Synopsis: OA describes the persistent misuse of oxaliplatin in adjuvant chemotherapy regimens for older persons with colon cancer, despite the publication of level 1 evidence and revised NCCN guidelines recommending against its use. Focused quality....Read Article >>