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Research Overview

Dr. Gray is a faculty member at Boston Children’s Hospital. She is the Assistant Director of Statistical Informatics within the Institutional Centers for Clinical and Translational Research (ICCTR) and the senior statistician in the Division of General Pediatrics. Her current collaborative research focuses on the study design, implementation, and analysis of medical care outcomes, clinical, translational, and observational studies that involve use of large registry databases and electronic health records (EHR). She is interested in the applications of statistical methodology, including survival analysis, competing risks, longitudinal and correlated data analysis, and hierarchical or multilevel analysis.


Dr. Gray currently serves as a voting member of Gynecologic Cancers Steering Committee (GCSC) at US National Cancer Institute (NCI) and provides statistical reviews of research proposals/concepts for new phase II/III gynecologic Cancer trials and engage in strategic planning that determines directions for NCI-funded trials in gynecologic cancers.
Dr Gray is also deeply committed to mentoring and supporting fellows and junior faculty.

Research Background

Dr. Gray received her doctoral degree in biostatistics from Harvard University and has extensive experience collaborating with clinical researchers from multiple disciplines, including HIV/AIDs, cancers and other diseases. Her work has included collaborating on phase I-III clinical trials and correlative research projects in multiple cancer therapeutic disease areas at Dana Farber Cancer Institute and providing statistical guidance and support for NIH, industry sponsored and other grants. Most recently, she served as the Director of Biostatistics and the Principal Research Scientist at the Frontier Science & Technology Research Foundation, where she led the Statistics and Programming team and provided leadership and statistical guidance in the collaborations with pharmaceutical companies for the licensure studies that investigated the pediatric dosing for new antiretroviral therapies for the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) network, which conducts pediatric HIV/AIDS clinical trials. The work contributed to getting key antiretroviral medications licensed by US Food and Drug Administration (FDA) or European Medicines Agency (EMA) approval for pediatric use at doses appropriate for children.

Publications

  1. Insurance gaps at age-19 and age-26 health insurance eligibility thresholds by childhood-onset condition severity, Colorado 2014-2018. Health Serv Res. 2025 Jan 12; e14432. View Abstract
  2. A Coproduced Family Reporting Intervention to Improve Safety Surveillance and Reduce Disparities. Pediatrics. 2024 Oct 01; 154(4). View Abstract
  3. Multiplexed high-throughput immune cell imaging in patients with high-risk triple negative early breast cancer: Analysis from the International Breast Cancer Study Group (IBCSG) Trial 22-00. Eur J Cancer. 2024 Mar; 200:113535. View Abstract
  4. Impact of the COVID-19 Pandemic on Childhood Lead Testing and Blood Lead Levels. Acad Pediatr. 2024 Jul; 24(5):810-814. View Abstract
  5. A Patient Portal Intervention to Promote Adolescent and Young Adult Self-Management Skills. Acad Pediatr. 2023 08; 23(6):1252-1258. View Abstract
  6. Pharmacokinetics, Tolerability, and Safety of Doravirine and Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate Fixed-Dose Combination Tablets in Adolescents Living With HIV: Week 24 Results From IMPAACT 2014. J Acquir Immune Defic Syndr. 2023 02 01; 92(2):153-161. View Abstract
  7. Pharmacokinetics, safety, tolerability, and antiviral activity of dolutegravir dispersible tablets in infants and children with HIV-1 (IMPAACT P1093): results of an open-label, phase 1-2 trial. Lancet HIV. 2022 05; 9(5):e332-e340. View Abstract
  8. Tumor infiltrating lymphocyte stratification of prognostic staging of early-stage triple negative breast cancer. NPJ Breast Cancer. 2022 Jan 11; 8(1):3. View Abstract
  9. Genomic Aberrations and Late Recurrence in Postmenopausal Women with Hormone Receptor-positive Early Breast Cancer: Results from the SOLE Trial. Clin Cancer Res. 2021 01 15; 27(2):504-512. View Abstract
  10. Colonoscopist Performance and Colorectal Cancer Risk After Adenoma Removal to Stratify Surveillance: Two Nationwide Observational Studies. Gastroenterology. 2021 03; 160(4):1067-1074.e6. View Abstract
  11. Dual Blockade of c-MET and the Androgen Receptor in Metastatic Castration-resistant Prostate Cancer: A Phase I Study of Concurrent Enzalutamide and Crizotinib. Clin Cancer Res. 2020 12 01; 26(23):6122-6131. View Abstract
  12. Bone targeted therapy and skeletal related events in the era of enzalutamide and abiraterone acetate for castration resistant prostate cancer with bone metastases. Prostate Cancer Prostatic Dis. 2021 06; 24(2):341-348. View Abstract
  13. Assessment of Combined Nivolumab and Bevacizumab in Relapsed Ovarian Cancer: A Phase 2 Clinical Trial. JAMA Oncol. 2019 12 01; 5(12):1731-1738. View Abstract
  14. Transcriptome analysis reveals overlap in fusion genes in a phase I clinical cohort of TNBC and HGSOC patients treated with buparlisib and olaparib. J Cancer Res Clin Oncol. 2020 Feb; 146(2):503-514. View Abstract
  15. Results of a Multicenter Phase II Study of Atezolizumab and Bevacizumab for Patients With Metastatic Renal Cell Carcinoma With Variant Histology and/or Sarcomatoid Features. J Clin Oncol. 2020 01 01; 38(1):63-70. View Abstract
  16. Mutations and Response to Rapalogs in Patients with Metastatic Renal Cell Carcinoma. Mol Cancer Ther. 2020 02; 19(2):690-696. View Abstract
  17. Phase II Study of Avelumab in Patients With Mismatch Repair Deficient and Mismatch Repair Proficient Recurrent/Persistent Endometrial Cancer. J Clin Oncol. 2019 10 20; 37(30):2786-2794. View Abstract
  18. Independent Validation of EarlyR Gene Signature in BIG 1-98: A Randomized, Double-Blind, Phase III Trial Comparing Letrozole and Tamoxifen as Adjuvant Endocrine Therapy for Postmenopausal Women With Hormone Receptor-Positive, Early Breast Cancer. JNCI Cancer Spectr. 2019 Dec; 3(4):pkz051. View Abstract
  19. Results from a single arm, single stage phase II trial of trametinib and GSK2141795 in persistent or recurrent cervical cancer. Gynecol Oncol. 2019 07; 154(1):95-101. View Abstract
  20. Tumor-Infiltrating Lymphocytes and Prognosis: A Pooled Individual Patient Analysis of Early-Stage Triple-Negative Breast Cancers. J Clin Oncol. 2019 03 01; 37(7):559-569. View Abstract
  21. Impact of new systemic therapies on overall survival of patients with metastatic castration-resistant prostate cancer in a hospital-based registry. Prostate Cancer Prostatic Dis. 2019 09; 22(3):420-427. View Abstract
  22. Neoadjuvant Degarelix Versus Triptorelin in Premenopausal Patients Who Receive Letrozole for Locally Advanced Endocrine-Responsive Breast Cancer: A Randomized Phase II Trial. J Clin Oncol. 2019 02 10; 37(5):386-395. View Abstract
  23. Compound Genomic Alterations of TP53, PTEN, and RB1 Tumor Suppressors in Localized and Metastatic Prostate Cancer. Eur Urol. 2019 07; 76(1):89-97. View Abstract
  24. Loss of PTEN Expression Detected by Fluorescence Immunohistochemistry Predicts Lethal Prostate Cancer in Men Treated with Prostatectomy. Eur Urol Oncol. 2019 09; 2(5):475-482. View Abstract
  25. A dose finding clinical trial of cabozantinib (XL184) administered in combination with abiraterone acetate in metastatic castration-resistant prostate cancer. Prostate. 2018 Jun 07. View Abstract
  26. Radium-223 Dichloride in Combination with Vascular Endothelial Growth Factor-Targeting Therapy in Advanced Renal Cell Carcinoma with Bone Metastases. Clin Cancer Res. 2018 09 01; 24(17):4081-4088. View Abstract
  27. Time of metastatic disease presentation and volume of disease are prognostic for metastatic hormone sensitive prostate cancer (mHSPC). Prostate. 2018 09; 78(12):889-895. View Abstract
  28. Mutational analysis of triple-negative breast cancers within the International Breast Cancer Study Group (IBCSG) Trial 22-00. Breast Cancer Res Treat. 2018 Jul; 170(2):351-360. View Abstract
  29. Differential expression of c-Met between primary and metastatic sites in clear-cell renal cell carcinoma and its association with PD-L1 expression. Oncotarget. 2017 Nov 28; 8(61):103428-103436. View Abstract
  30. High Expression of FGD3, a Putative Regulator of Cell Morphology and Motility, Is Prognostic of Favorable Outcome in Multiple Cancers. JCO Precis Oncol. 2017; 1. View Abstract
  31. TOP2A and EZH2 Provide Early Detection of an Aggressive Prostate Cancer Subgroup. Clin Cancer Res. 2017 Nov 15; 23(22):7072-7083. View Abstract
  32. Reply to L. Moscetti. J Clin Oncol. 2017 05 10; 35(14):1628. View Abstract
  33. Impact of CYP19A1 and ESR1 variants on early-onset side effects during combined endocrine therapy in the TEXT trial. Breast Cancer Res. 2016 11 08; 18(1):110. View Abstract
  34. Tumor-infiltrating lymphocytes (TILs) are a powerful prognostic marker in patients with triple-negative breast cancer enrolled in the IBCSG phase III randomized clinical trial 22-00. Breast Cancer Res Treat. 2016 07; 158(2):323-31. View Abstract
  35. Low-Dose Oral Cyclophosphamide and Methotrexate Maintenance for Hormone Receptor-Negative Early Breast Cancer: International Breast Cancer Study Group Trial 22-00. J Clin Oncol. 2016 10 01; 34(28):3400-8. View Abstract
  36. Pharmacogenomic Markers of Targeted Therapy Toxicity in Patients with Metastatic Renal Cell Carcinoma. Eur Urol Focus. 2016 Dec 15; 2(6):633-639. View Abstract
  37. Risk of prostate cancer-specific death in men with baseline metabolic aberrations treated with androgen deprivation therapy for biochemical recurrence. BJU Int. 2016 Dec; 118(6):919-926. View Abstract
  38. Secretory leukocyte protease inhibitor is a survival and proliferation factor for castration-resistant prostate cancer. Oncogene. 2016 09 08; 35(36):4807-15. View Abstract
  39. Mutations in TSC1, TSC2, and MTOR Are Associated with Response to Rapalogs in Patients with Metastatic Renal Cell Carcinoma. Clin Cancer Res. 2016 05 15; 22(10):2445-2452. View Abstract
  40. Twelve-Month Estrogen Levels in Premenopausal Women With Hormone Receptor-Positive Breast Cancer Receiving Adjuvant Triptorelin Plus Exemestane or Tamoxifen in the Suppression of Ovarian Function Trial (SOFT): The SOFT-EST Substudy. J Clin Oncol. 2016 05 10; 34(14):1584-93. View Abstract
  41. ESR1 and ESR2 polymorphisms in the BIG 1-98 trial comparing adjuvant letrozole versus tamoxifen or their sequence for early breast cancer. Breast Cancer Res Treat. 2015 Dec; 154(3):543-55. View Abstract
  42. CYP19A1 polymorphisms and clinical outcomes in postmenopausal women with hormone receptor-positive breast cancer in the BIG 1-98 trial. Breast Cancer Res Treat. 2015 Jun; 151(2):373-84. View Abstract
  43. Docetaxel, bevacizumab, and androgen deprivation therapy for biochemical disease recurrence after definitive local therapy for prostate cancer. Cancer. 2015 Aug 01; 121(15):2603-11. View Abstract
  44. Patients with Biopsy Gleason 9 and 10 Prostate Cancer Have Significantly Worse Outcomes Compared to Patients with Gleason 8 Disease. J Urol. 2015 Jul; 194(1):91-7. View Abstract
  45. Craniocaudal retroperitoneal node length as a risk factor for relapse from clinical stage I testicular germ cell tumor. AJR Am J Roentgenol. 2014 Oct; 203(4):W415-20. View Abstract
  46. PD-L1 expression in nonclear-cell renal cell carcinoma. Ann Oncol. 2014 Nov; 25(11):2178-2184. View Abstract
  47. Elevated APOBEC3B correlates with poor outcomes for estrogen-receptor-positive breast cancers. Horm Cancer. 2014 Dec; 5(6):405-13. View Abstract
  48. Elevated IL-8, TNF-a, and MCP-1 in men with metastatic prostate cancer starting androgen-deprivation therapy (ADT) are associated with shorter time to castration-resistance and overall survival. Prostate. 2014 Jun; 74(8):820-8. View Abstract
  49. A meta-analysis of patient outcomes with subcentimeter disease after chemotherapy for metastatic non-seminomatous germ cell tumor. Ann Oncol. 2014 Feb; 25(2):331-8. View Abstract
  50. Elevated insulin-like growth factor binding protein-1 (IGFBP-1) in men with metastatic prostate cancer starting androgen deprivation therapy (ADT) is associated with shorter time to castration resistance and overall survival. Prostate. 2014 Feb; 74(3):225-34. View Abstract
  51. Adjuvant pegylated liposomal doxorubicin for older women with endocrine nonresponsive breast cancer who are NOT suitable for a "standard chemotherapy regimen": the CASA randomized trial. Breast. 2013 Apr; 22(2):130-137. View Abstract
  52. Genetic variants in the host restriction factor APOBEC3G are associated with HIV-1-related disease progression and central nervous system impairment in children. J Acquir Immune Defic Syndr. 2013 Feb 01; 62(2):197-203. View Abstract
  53. Single nucleotide polymorphisms and risk of recurrence of renal-cell carcinoma: a cohort study. Lancet Oncol. 2013 Jan; 14(1):81-7. View Abstract
  54. Obesity and risk of recurrence or death after adjuvant endocrine therapy with letrozole or tamoxifen in the breast international group 1-98 trial. J Clin Oncol. 2012 Nov 10; 30(32):3967-75. View Abstract
  55. HLA alleles are associated with altered risk for disease progression and central nervous system impairment of HIV-infected children. J Acquir Immune Defic Syndr. 2011 May 01; 57(1):32-9. View Abstract
  56. Presence of the metabolic syndrome is associated with shorter time to castration-resistant prostate cancer. Ann Oncol. 2011 Apr; 22(4):801-807. View Abstract
  57. Analyses of cumulative incidence functions via non-parametric multiple imputation. Stat Med. 2008 Nov 29; 27(27):5709-24. View Abstract
  58. Efficacy, safety and tolerability of tipranavir coadministered with ritonavir in HIV-1-infected children and adolescents. AIDS. 2008 Sep 12; 22(14):1789-98. View Abstract
  59. An age-dependent association of mannose-binding lectin-2 genetic variants on HIV-1-related disease in children. J Allergy Clin Immunol. 2008 Jul; 122(1):173-80, 180.e1-2. View Abstract
  60. Sensitivity analysis of progression-free survival with dependent withdrawal. Stat Med. 2008 Apr 15; 27(8):1180-98. View Abstract
  61. Virologic response to potent antiretroviral therapy and modeling of HIV dynamics in early pediatric infection. J Infect Dis. 2007 Jul 01; 196(1):23-9. View Abstract
  62. A method for analyzing disease-specific mortality with missing cause of death information. Lifetime Data Anal. 2006 Mar; 12(1):35-51. View Abstract
  63. Rapid human immunodeficiency virus decay in highly active antiretroviral therapy (HAART)-experienced children after starting mega-HAART. J Virol. 2004 Oct; 78(20):11272-5. View Abstract
  64. Activity, safety, and immunological effects of hydroxyurea added to didanosine in antiretroviral-naive and experienced HIV type 1-infected subjects: a randomized, placebo-controlled trial, ACTG 307. AIDS Res Hum Retroviruses. 2004 Sep; 20(9):916-26. View Abstract
  65. Relationship of plasma HIV-1 RNA dynamics to baseline factors and virological responses to highly active antiretroviral therapy in adolescents (aged 12-22 years) infected through high-risk behavior. J Infect Dis. 2004 Feb 15; 189(4):593-601. View Abstract
  66. Viral dynamics and their relations to baseline factors and longer term virologic responses in treatment-naive HIV-1-infected patients receiving abacavir in combination with HIV-1 protease inhibitors. J Acquir Immune Defic Syndr. 2003 Aug 15; 33(5):557-63. View Abstract
  67. Steady-state pharmacokinetic interaction of modified-dose indinavir and rifabutin. Clin Pharmacol Ther. 2003 Mar; 73(3):159-69. View Abstract

Contact Kathryn P. Gray