On September 30, 2014, more than 150 participants, including employees of GSK, members of the Duke Department of Biostatistics and Bioinformatics and Master’s and PhD biostatistics students from Duke, attended the second Joint GSK-Duke Workshop on Critical Statistical Issues for Drug Development, held at Duke in the Hock Plaza building, the home of the Duke Department of Biostatistics and Bioinformatics.
The program led off with a keynote address, “Innovation and Statistics in Clinical Trials,” by Greg Campbell, Director, Division of Biostatistics, Center for Devices and Radiological Health, Food and Drug Administration, and was followed by six sessions that offered 18 presentations, in addition to a poster session, and a Q&A panel discussion.
This year’s workshop solidified the relationship that blossomed with the inaugural GSK-Duke joint workshop held last year at GSK’s campus nine miles away in Research Triangle Park. “Last year felt very much like a first date,” said Dr. Sara Hughes, VP and Head, Clinical Statistics of GSK. “This year we have moved on to our second date, learning more about each other and what we do, engaging in meaty talks, and provoking new ideas.”
Dr. Liz DeLong, Chair of the Duke Department of Biostatistics and Bioinformatics, praised the mutual exchange. “This day-long workshop provides an exciting opportunity for us to integrate and partner with those in industry, and learn up-to-the-minute information such as we did this morning about the FDA in Greg Campbell’s keynote this morning.”
July 28, 2014
Dr. DeLong and Dr. Chow were invited by Dr. Junzhi Wang, Deputy Director-General of National Institutes for Food and Drug Control (NIFDC) of China Food and Drug Administration (CFDA) to sign an MOU on biostatistics and bioinformatics collaboration between Duke B&B and ICDC (Institute for Chemical Drug Control) of NIFDC in Beijing, China. The MOU was signed by Dr. DeLong (Duke B&B) and Dr. Huaxin Yang (ICDC of NIFDC) under supervision of Dr. Junzhi Wang followed by group photo and seminars by Dr. DeLong. She spoke on the expanding role of biostatistics at Duke and Dr. Chow spoke on Good Statistics Practices in non-clinical drug research and development).
Dr. Dejiang Tan (Deputy Director of ICDC) and Dr. Chow have been identified as the primary contact people for this collaboration. Both of them will identify topics and research areas of common interest in pharmaceutical research and development and circulate within B&B and colleagues in NIFDC in the near future. The collaboration between Duke B&B and ICDC/NIFDC will provide the opportunity for our faculty to participate joint research with scientists and principal investigators at ICDC/NIFDC in pharmaceutical research and development.
July 7, 2014
Susan Halabi was elected as a Fellow for the Society of Clinical Trials, Class of 2014. The award is given as a recognition for outstanding professional contributions to the scientific community and leadership in clinical trials. The citation read at the Annual Meeting: "For her outstanding leadership in cancer clinical trials and prognostic development, particularly her work in the Cancer and Leukemia Group B, now part of the Alliance for Clinical Trial in Oncology, that focused on genitourinary cancers in which she designed and analyzed dozens of clinical trials that have informed new treatment approaches for prostate cancer and other GU malingnancies, identified important associations between biological factors and treatment outcomes and impacted the quality of life of cancer patients; for her educational activities; and for dedicated service on national review committees, DSMBs and scientific advisory committees and for the Society of Clinical Trials."
July 1, 2014
A new compilation of the world's most cited scientists released by Thomson Reuters, includes Biostat faculty member Michael Pencina along with 31 other Duke researchers. The list includes 3215 most-cited scientists who are in the top one pecent of their fields. Most-cited means a paper has been named frequently in references by other papers in that field. And that "is a measure of gross influence that often correlates well with community perceptions of research leaders within a field," Thomson Reuters says. The Thomson Reuters analysis is based on their Web of Science database.
June 25, 2014
Dr. Susan Halabi recently presented at the American Society of Clinical Oncology Annual Meeting in Chicago, as part of the featured research. Dr. Halabi reported that lung metastases were associated with 30% increased risk adjusted odds of death compared with men with bone metastatic disease.
Furthermore, men with liver metastases had 40% increased risk of death compared with lung metastases after adjustment for performance status, prostate specific antigen (PSA), and age. This study has potential implications for the management and treatment of these patients; these prognostic subgroups may be considered in the design of future targeted trials in metastatic castration-resistant prostate cancer. For more information, see the News and Updates section. Watch the interview here.
May 30, 2014
B&B PhD student Yu Jiang was the lead author for a paper that presents a new statistical framework with greatly improved power to assess the role of rare genetic catiation in human disease. The approach is detailed in the June 5 issue of the American Journal of Human Genetics. According to senior author and B&B faculty member Andrew Allen, PhD, this new frame work is far more powerful than previous methods for interrogating rare vaiation because it draws in additional information from large population control samples. Yu is a PhD student of Andrew Allen who focuses on developing new statistical methods for identifying susceptibility loci involved in complex human disease. This involves a mix of genetics, statistics, and computer science and is motivated by the complexities of real data encountered in collaborative disease-gene mapping projects. For more information, please see our News and Updates Section.
May 11, 2014
Duke University held its 162nd Commencement Ceremony on Sunday morning, May 11, at Wallace Wade Stadium. The day before the main Duke ceremony, the Department of Biostatistics and Bioinformatics held its annual diploma and awards reception. This year, the Department recognized 22 students with a Master of Biostatistics. Special awards were given to Fan Li who received the Overall Academic Excellence award, Steven Wolf, who received the Student Initiative Award, and Lauren Howard who received the Student Leadership Award. Fan Li served as the Student Marshall at Duke Commencement.
March 31, 2014
Michael Pencina led an analysis published in the New England Journal of Medicine that found almost half of Americans ages 40 to 75 and nearly all men over 60 qualify to consider cholesterol-lowering statin drugs under new heart disease prevention guidelines. "The numbers tell a story about how much heart diseasewe still have in the U.S.," Pencina said. "In fairness they are just guidelines to start the conversation." This study was carried by newspapers and online news sites nationwide. The full AP article here.
Building on its successful Master of Biostatistics Program, the Department of Biostatistics and Bioinformatics is offering a Ph.D. in Biostatistics through the Graduate School of Duke University. As with the master’s program, the Ph.D. program will emphasize the three core competencies of analytical thinking, biomedical understanding of the disease process, and communication. A key component of the program is its integration with the Duke medical research enterprise. Students will have the advantage of studying and working alongside medical investigators tackling real-life biomedical problems.
January 24, 2014
Steve Grambow received the Teaching of Statistics in Health Sciences (TSHS) Section's Best Contributed Paper Award for JSM 2013 for his presentation, "Doctors and Data Analysis: A Dangerous Mix?" The presentation was part of a contributed papers session on "Biostatistical Literacy: What Medical and Public Health Professionals Need to Know about Statistics." Steve served as the 2013 Section Chair of the TSHS a section of the American Statistical Association. The section is devoted to excellence in teaching statistical methods and basic epidemiology and in statistical consulting within the health sciences.
January 15, 2014
Susan Halabi's article "Progression-Free Survival (PFS) as a Surrogate Endpoint of Overall Survival (OS) in Patients with Metastatic Renal Cell Carcinoma (mRCC)" was chosen as a featured article and placed on the cover of Cancer. Cancer is an official journal of the American Cancer Society and reaches over 20 million people worldwide. For more information, please see our News and Updates Section.
November 20, 2013
Raluca Gordon's recent article "Genomic regions flanking E-box binding site influence DNA binding specificity of bHLH transciption factors through DNA shale" has been selected as one of the top 10 papers in Regulatory and Systems Genomics for 2012-2013 at RECOMB/ISCB Regulatory and Systems Genomics Meeting in Toronto in November 2013. For more information please see our News and Updates Section.
November 12, 2013
During his visit to the Department of Biostatistics and Bioinformatics, Dr. Bradley Efron had the opportunity to share lunch with our second-year students and to attend a class on biology and communication taken by our first-year students. Much of the discussion over lunch pertained to data science as an emerging career, and what statisticians can do to prepare themselves for the role of data scientist. The class was deconstructing a manuscript describing a randomized trial, using a question and answer format. Rather like a game show, students are encouraged to answer for themselves (in fact, they are encouraged to discuss the questions beforehand within their study groups), but lifelines are available if needed. Dr. Efron provided the ultimate lifeline for the questions on bootstrapping!
November 1, 2013
The first GlaxoSmithKline (GSK)-Duke Statistics Workshop on Critical Statistical Issues in Drug Development was held on October 29, 2013 at the GSK Research Triangle Park location. This is an important first step for biostatistics collaboration between GSK and Duke with the goal to exchange research progress and new ideas on critical statistical issues in clinical development. It was well attended with over 100 participants from both Duke and GSK.
Dr. Liz DeLong and Dr. Michael Pencina of the Duke Clinical Research Institute and Dr. Sara Hughes and Dr. John Whittaker, of GSK gave opening remarks. Dr. Stephen George and Dr. Kerry Lee from Duke Biostatistics and Bioinformatics presented their perspectives on design and analysis issues in drug development. Dr. Paul McSorley and Dr. Steve Novick discussed challenges and issues involved in pre/non-clinical research and data sharing for industry trials.
The GSK-Duke Statistics Workshop will be an annual event for GSK and Duke. For more information and future event details, please see the GSK-Duke Statistics website.
Duke faculty and GSK researchers discuss statistical issues in clinical development.