The focus of the Biostatistics Shared Resource (BSSR) is to collaborate with and provide support to Wake Forest Baptist Comprehensive Cancer Center members by providing analytical expertise and rigor that enhances peer-reviewed research to reduce the incidence of cancer, improve response and survival, reduce morbidity, manage symptoms, improve health-related quality of life and translate important laboratory discoveries into clinical practice.
Goals and Focus Areas
The focus of the BSSR is to collaborate with and provide support to Wake Forest Baptist Comprehensive Cancer Center members by providing analytical expertise and rigor that:
- Enhance peer-reviewed research to reduce the incidence of cancer.
- Improve response and survival.
- Reduce morbidity.
- Manage symptoms.
- Improve health-related quality of life.
- Translate important laboratory discoveries into clinical practice.
The BSSR is responsible for methodological, statistical and analytical issues that may arise during projects. It is also responsible for computational issues, including study design, sampling, statistical aspects of clinical trial monitoring, interim reviews and final analyses.
These responsibilities are encompassed within the BSSR’s four goals:
- Goal 1: Support investigator-initiated clinical protocol development, including developing appropriate statistical designs, preparing statistical sections, and reviewing the statistical content of protocols submitted for review to the Protocol Review Committee of the Comprehensive Cancer Center.
- Goal 2: Provide operational and analytical support for clinical protocols, including monitoring patient accrual, providing support for quality assurance efforts, and performing interim and final analyses when needed.
- Goal 3: Collaborate with Comprehensive Cancer Center investigators from all programs to provide statistical design and data analysis in support of grant development, abstracts, presentations and publications.
- Goal 4: Provide leadership, education and training in support of the Comprehensive Cancer Center mission, including participation in graduate-level courses, T32-supported training grants, mentoring teams for K awardees and other young investigators, and leadership on committees responsible for scientific and administrative decisions for the Comprehensive Cancer Center, as well as conducting multiple seminar series on topics such as meta-analysis, survival analysis and early-phase adaptive designs for Comprehensive Cancer Center members.
Each DOT has at least two named statisticians identified to provide statistical support to its members. This includes at least one faculty member and one staff-level statistician.
|DOT||Faculty Biostatistician||Staff Statistician|
|Brain (Neuro-Oncology)||Ralph D’Agostino/Fang-Chi Hsu||Beverly Levine|
|Breast||Janet Tooze/Carl Langefeld||Greg Russell|
|Cancer Control and Survivorship||Janet Tooze||Beverly Levine/Scott Isom|
|GI||Ralph D’Agostino||Greg Russell |
|GU||Ralph D’Agostino||Scott Isom|
|Gynecologic Oncology||Fang-Chi Hsu||Beverly Levine|
|Hematologic Malignancies||Janet Tooze||Scott Isom|
|Head and Neck||Ralph D’Agostino||Scott Isom|
|Lung||Ralph D’Agostino||Beverly Levine|
|Melanoma||Fang-Chi Hsu||Greg Russell|
|Pediatric Oncology||Janet Tooze||Beverly Levine|
|Phase I and Precision Medicine||Ralph D’Agostino||Scott Isom|
|Sarcoma||Janet Tooze||Greg Russell|
Alistar A, Morris BB, Desnoyer R, Klepin HD, Hosseinzadeh K, Clark C, Cameron A, Leyendecker J, D'Agostino R Jr, Topaloglu U, Boteju LW, Boteju AR, Shorr R, Zachar Z, Bingham PM, Ahmed T, Crane S, Shah R, Migliano JJ, Pardee TS, Miller L, Hawkins G, Jin G, Zhang W, Pasche B. Safety and tolerability of the first-in-class agent CPI-613 in combination with modified FOLFIRINOX in patients with metastatic pancreatic cancer: a single-centre, open-label, dose-escalation, phase 1 trial. Lancet Oncol. 2017 May 8. pii: S1470-2045(17)30314-5. doi: 10.1016/S1470-2045(17)30314-5. [Epub ahead of print] PMID:28495639
Yang M, Topaloglu U, Petty WJ, Pagni M, Foley KL, Grant SC, Robinson M, Bitting RL, Thomas A, Alistar AT, Desnoyers RJ, Goodman M, Albright C, Porosnicu M, Vatca M, Qasem SA, DeYoung B, Kytola V, Nykter M, Chen K, Levine EA, Staren ED, D'Agostino RB Jr, Petro RM, Blackstock W, Powell BL, Abraham E, Pasche B, Zhang W. Circulating mutational portrait of cancer: manifestation of aggressive clonal events in both early and late stages. J Hematol Oncol. 2017 May 4;10(1):100. doi: 10.1186/s13045-017-0468-1. PMID:28472989
Rugo HS, Klein P, Melin SA, Hurvitz SA, Melisko ME, Moore A, Park G, Mitchel J, Bågeman E, D'Agostino RB Jr, Ver Hoeve ES, Esserman L, Cigler T. Association between use of a scalp cooling device and alopecia after chemotherapy for breast cancer. JAMA. 2017 Feb 14;317(6):606-614. doi: 10.1001/jama.2016.21038. PMID:28196257
Jordan JH, Sukpraphrute B, Meléndez GC, Jolly MP, D'Agostino RB Jr, Hundley WG. Early myocardial strain changes during potentially cardiotoxic chemotherapy may occur as a result of reductions in left ventricular end-diastolic volume: the need to interpret left ventricular strain with volumes. Circulation. 2017 Jun 20;135(25):2575-2577. doi: 10.1161/CIRCULATIONAHA.117.027930. PMID:28630272
Klepin HD, Tooze JA, Pardee TS, Ellis LR, Berenzon D, Mihalko SL, Danhauer SC, Rao AV, Wildes TM, Williamson JD, Powell BL, Kritchevsky SB. Effect of intensive chemotherapy on physical, cognitive, and emotional health of older adults with acute myeloid leukemia. J Am Geriatr Soc. 2016 Oct;64(10):1988-1995. doi: 10.1111/jgs.14301. Epub 2016 Sep 14.PMID:27627675
Maggiore RJ, Callahan KE, Tooze JA, Parker IR, Hsu T, Klepin HD. Geriatrics fellowship training and the role of geriatricians in older adult cancer care: A survey of geriatrics fellowship directors. Gerontol Geriatr Educ. 2016 Oct 17:1-13. doi: 10.1080/02701960.2016.1247070. [Epub ahead of print] PMID:27749199
Sterba KR, Garrett-Mayer E, Carpenter MJ, Tooze JA, Hatcher JL, Sullivan C, Tetrick LA, Warren GW, Day TA, Alberg AJ, Weaver KE. Smoking status and symptom burden in surgical head and neck cancer patients. Laryngoscope. 2017 Jan;127(1):127-133. doi: 10.1002/lary.26159. Epub 2016 Jul 9. PMID:27392821