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Development of new randomized phase II clinical trial designs.
Application of state of the art statistical approaches to rigorously extend the quantitative interpretation of data.
Large-scale data integration, and the development and application of web-based technologies to enable remote data collection/presentation, health education and new interventions.
Our research focuses on the development and innovative use of quantitative methods and information technology in cancer research. Our statistical methodology has concentrated on the design of efficient Phase II oncology clinical trials. Our collaborations with numerous investigators conducting clinical, translational, cancer control, epidemiology, and basic science research rigorously extend the quantitative interpretation of results from these disciplines. Improving research efficiency and data quality through the novel application of computer-based methods is another area of active interest. Special areas of investigation include large-scale data integration and the development of web-based technologies to enable remote data collection/presentation, health education and new interventions.
Our research focuses on the innovative use of quantitative methods and information technology in cancer research.
Recently, my statistical methodology research has focused on the creation of more efficient clinical trial designs. In collaboration with Dr. Sam Litwin, we developed a new randomized two-arm, two-stage, phase II design for clinical trials with a binary primary outcome (e.g., response). The goal was to reduce the number of patients needed for rigorous analysis. Conceptually, this new design is a fusion of the Simon two-stage one-sample and traditional two-sample randomized approaches. It overcomes limitations of the one-sample design while requiring much smaller patient numbers than traditional comparative designs through sculpting of the critical region. The new design will identify therapy that has a success rate exceeding historical standards and is better than its simultaneous control. This work was published in Statistics and Medicine.
As Director of Fox Chase’s Biostatistics and Bioinformatics Facility, I am responsible for coordinating and supervising statistical and bioinformatics activities to ensure that all investigators receive high quality support. I provide quantitative expertise for clinical trials, non-therapeutic interventional studies, biomarker analyses, animal model experiments and pre-clinical investigations. My collaborations with numerous investigators conducting clinical, translational, cancer control, epidemiology, and basic science research rigorously extend the quantitative interpretation of results from these disciplines. Many of these investigations extended across multiple studies, involved the analysis of diverse data types and resulted in new insights into cancer treatment, prevention or development. For example, Dr. Plimack and I demonstrated the efficacy of neoadjuvant accelerated methotrexate, vinblastine, doxorubicin, and cisplatin in muscle-invasive bladder cancer (MIBC). We also analyzed DNA-seq panel data from pretreatment tumors to discover an important molecular profile. This profile is based on mutations in any one of 3 specific DNA-repair genes and it identifies patients who will achieve complete pathologic response with high accuracy. These findings, published in the Journal of Clinical Oncology and European Urology, provided support for our development of a phase II, parallel arm, multi-institutional clinical trial to evaluate a risk-adapted approach to treatment of MIBC that could improve quality of life and decrease morbidity. It does so by sparing some patients cystectomy or chemoradiation after neoadjuvant chemotherapy without compromising outcomes.
I also direct Fox Chase’s Population Studies Facility (PSF). In this role I oversee the Cancer Center’s research informatics activities. The PSF provides access to a team of information systems professionals with experience in state-of-the-art software engineering applied to cancer research. Our informatics research facilitates cancer investigations by promoting the use of computer-based methods that improve research efficiency and data quality. Special areas of interest include large-scale data integration, and the development and application of web-based technologies to enable remote data collection/presentation, health education and new interventions.
Shulman R.M., Weinberg D.S., Ross E.A., Ruth K., Rall G.F., Olszanski A.J., Helstrom J., Hall M.J., Judd J., Chen D.Y.T., Uzzo R.G., Dougherty T.P., Williams R., Geynisman D.M., Fang C.Y., Fisher R.I., Strother M., Huelsmann E., Adige S., Whooley P.D., Zarrabi K., Gupta B., Iyer P., McShane M., Yankey H., Lee C.T., Burbure N., Laderman L.E., Giurintano J., Reiss S., Horwitz E.M., Adverse events reported by patients with cancer after administration of a 2-dose mrna covid-19 vaccine. J Natl Compr Canc Netw. 20(2): 160-166, 2022. https://www.ncbi.nlm.nih.gov/pubmed/35130494.
Tan Y., Sementino E., Cheung M., Peri S., Menges C.W., Kukuyan A.M., Zhang T., Khazak V., Fox L.A., Ross E.A., Ramanathan S., Jhanwar S.C., Flores R.M., Balachandran S., Testa J.R., Somatic epigenetic silencing of ripk3 inactivates necroptosis and contributes to chemoresistance in malignant mesothelioma. Clin Cancer Res. 27(4): 1200-1213, 2021. PMC7887036. https://www.ncbi.nlm.nih.gov/pubmed/33203643.
Weinberg DS, Pickhardt PJ, Bruining DH, Edwards K, Fletcher JG, Gollub MJ, Keenar EM, Kupfer SS, Li T, Lubner SJ, Markowitz AJ, Ross EA. Computed tomography colonography vs colonoscopy for colorectal cancer surveillance after surgery. Gastroenterology. 2018 Mar;154(4):927-934.e4 PubMed PMID: 29174927; PubMed Central PMCID: PMC5847443.
Egleston BL, Pedraza O, Wong YN, Griffin CL, Ross EA, Beck JR. Temporal trends and characteristics of clinical trials for which only one racial or ethnic group is eligible. Contemporary Clinical Trials Communications, 9:135-42, 2018. PMC5898501
Wagner J, Kline CL, Zhou LL, Campbell KS, MacFarlane AW, Olszanski AJ, Cai KQ, Hensley HH, Ross EA, Ralff MD, Zloza A, Chesson CB, Newman JH, Kaufman H, Bertino J, Stein M, El-Deiry WS. Dose intensification of TRAIL-inducing ONC201 inhibits metastasis and promotes intratumoral NK cell recruitment. Journal of Clinical Investigation, 128(6):2325-38, 2018. PubMed
Litwin S, Basickes S, Ross EA. Two-sample binary phase 2 trials with low type I error and low sample size. Stat Med. 2017 Apr 30;36(9):1383-1394. PubMed PMID: 28118686; PubMed Central PMCID: PMC5378610.
Peri S, Izumchenko E, Schubert AD, Slifker MJ, Ruth K, Serebriiskii IG, Guo T, Burtness BA, Mehra R, Ross EA, Sidransky D, Golemis EA. NSD1- and NSD2-damaging mutations define a subset of laryngeal tumors with favorable prognosis. Nat Commun, 8(1):1772, 2017. PMC5701248
Plimack, ER, Dunbrack, R, Brennan, T, Andrake, M, Zhou, Y, Serebriiskii, I, Wei, Q, Slifker, M, Alpaugh, K, Dulaimi, E, Palma, N, Hoffman-Censits, J, Bilusic, M, Wong, YN, Kutikov, A, Viterbo, R, Greenberg, RE, Chen, D, Lallas, CD, Trabulski, EJ, Yelensky, R, McConkey, D, Miller, VA, Golemis, E, Ross, E. Defects in DNA Repair Genes Predict Response to Neoadjuvant Cisplatin-based Chemotherapy in Muscle-invasive Bladder Cancer. Eur Urol. 2015; epub ahead of print PubMed
Weinberg DS, Myers RE, Keenan E, Ruth K, Sifri R, Ziring B, Ross E, Manne SL. Genetic and environmental risk assessment and colorectal cancer screening in an average-risk population: a randomized trial. Ann Intern Med. 2014 Oct 21;161(8):537-45. PubMed PMID: 25329201; PubMed Central PMCID: PMC4412019. PubMed
Plimack ER, Hoffman-Censits JH, Viterbo R, Trabulsi EJ, Ross EA, Greenberg RE, Chen DY, Lallas CD, Wong YN, Lin J, Kutikov A, Dotan E, Brennan TA, Palma N, Dulaimi E, Mehrazin R, Boorjian SA, Kelly WK, Uzzo RG, Hudes GR. Accelerated methotrexate, vinblastine, doxorubicin, and cisplatin is safe, effective, and efficient neoadjuvant treatment for muscle-invasive bladder cancer: results of a multicenter phase II study with molecular correlates of response and toxicity. J Clin Oncol. 2014 Jun 20;32(18):1895-901. PubMed PMID: 24821881; PubMed Central PMCID: PMC4050203. PubMed
Min H, Ohira R, Collins MA, Bondy J, Avis NE, Tchuvatkina O, Courtney PK, Moser RP, Shaikh AR, Hesse BW, Cooper M, Reeves D, Lanese B, Helba C, Miller SM, Ross EA. Sharing behavioral data through a grid infrastructure using data standards. J Am Med Inform Assoc. 2014 Jul-Aug;21(4):642-9. PubMed PMID: 24076749; PubMed Central PMCID: PMC4078270. PubMed
Bleicher RJ, Ruth K, Sigurdson ER, Ross E, Wong YN, Patel SA, Boraas M, Topham NS, Egleston BL. Preoperative delays in the US Medicare population with breast cancer. J Clin Oncol. 2012 Dec 20;30(36):4485-92. PubMed PMID: 23169513; PubMed Central PMCID: PMC3518727. PubMed
Ariazi EA, Cunliffe HE, Lewis-Wambi JS, Slifker MJ, Willis AL, Ramos P, Tapia C, Kim HR, Yerrum S, Sharma CG, Nicolas E, Balagurunathan Y, Ross EA, Jordan VC. Estrogen induces apoptosis in estrogen deprivation-resistant breast cancer through stress responses as identified by global gene expression across time. Proc Natl Acad Sci U S A. 2011 Nov 22;108(47):18879-86. PubMed PMID: 22011582; PubMed Central PMCID: PMC3223472. PubMed
Lewis JS, Meeke K, Osipo C, Ross EA, Kidawi N, Li T, Bell E, Chandel NS, Jordan VC. Intrinsic mechanism of estradiol-induced apoptosis in breast cancer cells resistant to estrogen deprivation. J Natl Cancer Inst. 2005 Dec 7;97(23):1746-59. PubMed PMID: 16333030. PubMed
Stoyanova R, Clapper ML, Bellacosa A, Henske EP, Testa JR, Ross EA, Yeung AT, Nicolas E, Tsichlis N, Li YS, Linehan WM, Howard S, Campbell KS, Godwin AK, Boman BM, Crowell JA, Kopelovich L, Knudson AG. Altered gene expression in phenotypically normal renal cells from carriers of tumor suppressor gene mutations. Cancer Biol Ther. 2004 Dec;3(12):1313-21. PubMed PMID: 15662135. PubMed
Evans AA, Chen G, Ross EA, Shen FM, Lin WY, London WT. Eight-year follow-up of the 90,000-person Haimen City cohort: I. Hepatocellular carcinoma mortality, risk factors, and gender differences. Cancer Epidemiol Biomarkers Prev. 2002 Apr;11(4):369-76. PubMed PMID: 11927497. PubMed
Ross EA, Moore D. Modeling clustered, discrete, or grouped time survival data with covariates. Biometrics. 1999 Sep;55(3):813-9. PubMed PMID: 11315011.