Welcome!

Duke Cancer Institute Spotlights the Biostatistics Shared Resource 

May 13, 2015 by William Alexander

In many ways, rocket science has nothing on cancer research.  Rocket science is firmly based on the reproducible domain of physics.  Rockets and fuels can be replicated en masse, and identical rockets will fly the same distance the first time as they do the thousandth.

But most cancer research takes place in a living laboratory. Even if you have a refined research topic in place–such as a new treatment or an at-risk population, this laboratory can present innumerable challenges to a study.

Some of the questions researchers at the DCI face every day include: How many patients of a rare cancer should be studied, and for how long, to estimate how well a treatment works? For rare diseases, how can a feasible design be formulated? What if the treatment is harmful or has side effects? Should fast- and slow-growing cancer types be lumped together or treated as separate categories? How can a researcher recruit underrepresented populations? And how can you assure that the data I collect will provide the information I will need to answer my question?

Fortunately, the Biostatistics Shared Resource exists to answer these (and other) questions. With full-time faculty and staff assigned to work in every program area, the group is the largest shared resource within the Duke Cancer Institute.

“Our shared resource is a bit different than others within the DCI,” said Terry Hyslop, PhD, director of the Biostatistics Shared Resource. We don’t have any machines or equipment. Instead we have a full cadre of people who work with investigators in everything from basic research to clinical trials to preparing adverse event reports. We run the whole gamut.”

DSC_1755

Biostatisticians Frances McSherry, MA, (left), James Herndon, PhD (center) and Patrick Healy, MS (right) are working to design, clarify logistical issues and study objectives, and determine the number of patients needed to address objectives for research using re-engineered polio viruses to fight a rare form of brain cancer.

Hyslop’s own busy schedule reveals the breadth of the shared resource’s work. A typical day might include regular research meetings with investigators about future clinical trials, abstract deadlines or data analysis, a discussion with Dan George, MD, and Steven Patierno, PhD, about using molecular analysis to better understand cancer disparities by integrating biology with socioeconomic status, and drafting a grant to examine populations at high risk for breast cancer for Dr. Hyslop’s own research.

“People come to us from all over the DCI with promising new research areas or ideas. We work to make that research the best it can be. That means a lot of thinking, designing, analyzing and thinking again during all stages of research,” Hyslop said.

This foresight and analysis will be especially useful for future research about the use of a re-engineered polio virus to treat glioblastoma, a rare form of brain cancer. A clinical trial featuring this technique recently gained national attention when it was covered on the news program 60 Minutes (read the story here).

James Herndon, PhD, a biostatistician who works with the Preston Robert Tisch Brain Tumor Center, and a member of the Biostatistics Shared Resource, has been working with Annick Desjardins, MD, Matthias Gromeier, MD, and other researchers on the conduct of this trial.

“The results so far have been promising, but we have so much more to learn,” Herndon said. “Right now I’m helping the team lay out the study design, clarify logistical issues and study objectives, and determine the number of patients needed to address these objectives. Biostatisticians Frances McSherry, MA and Patrick Healy, MS, are also part of the team that collaborate with Brain Tumor Center investigators and help them interpret their research data.”

“I see the job of our shared resource as a constant collaboration,” said Herndon. “There’s a high level of respect that runs back and forth between all the people we work with. We’re constantly talking back and forth, whether a project’s about to be finished or about future research further down the road.”

 

Andrzej Kosinski named Principal Investigator for new DCRI data analytic center for study: National Longitudinal Outcomes Following Surgical Therapy for Lung Cancer

May 12, 2015

Andrzej Kosinski, has been named the Principal Investigator for a new DCRI data analytic center for a study funded by the Agency for Healthcare Research and Quality (AHRQ) with the US Department of Health and Human Services. 

This project will use data from the Society of Thoracic Surgery General Thoracic Surgery Database and Medicare Inpatient Claims data to provide the first longitudinal lung cancer therapy outcomes on a national level. Researchers will also compare various approaches to surgical therapy for lung cancer and will explore cost across these approaches.

The study will focus on patients who are 65 years and older and will include data on approximately 40,000 patients.

 

Meredith Zozus receives funding to research discrepancies between Patients' medical records and self-reported data

April 29, 2015

Meredith Zozus has received nearly $1.4 million for a research project to expand involvement of patients in determining the accuracy of medical data used in research.  The funding for this study, “Measuring and talking to Patients about the Accuracy of Data used in Patient-Centered Outcomes Research” comes from the Patient Centered Outcomes Research Institute (PCORI). 

The study will compare self-reported data and electronic health record data to identify discrepancies. The researchers will then interview patients to identify the cause of the discrepancy and determine which data source is accurate and will examine the proportion of discrepancies that patients report to health systems and the likelihood that a reported discrepancy results in an actual change in the health record. Ultimately, the researchers want to know whether the changes affect guideline-based clinical decision-making.

“Eventually, we want to develop and test algorithms combining both self-reported and electronic health record data sources to see if we can develop algorithms that outperform either data source alone,” Zozus says.   Click here to read more.

Biostatistics Department offers new summer course on Next Gen Sequencing

April 27, 2015

With the increasing use of high throughput experiments to derive scientific results, the Biostatistics and Bioinformatics Department will offer a new 6 week course for students, postdocs, research staff and junior faculty to cover guidance on proper procedures to ensure experimental and statistical validity. The course will be held From July 13 to August 21.  For more information, visit our course page.  

To Register: click here for Application
Questions?  Email ngscourse@duke.edu for further information.

Biostatistics Department to hold Duke-Industry Statistical Symposium this fall

April 6, 2015

The Biostatistics and Bioinformatics Department is pleased to announce the upcoming Duke – Industry Statistical Symposium to be held October 22-23, 2015 on the Duke University Campus.  The theme is “Challenges and Innovations for Pharmaceutical Products Development.”

The symposium will promote research and collaboration among colleagues from industry, academia, and regulatory agencies to discuss challenging issues and recent advances related to the clinical development of drugs and devices. Department Chair Liz DeLong and representatives from industry and regular agencies will give opening remarks.  Dr Yi Tsong from the Center for Drug Evaluation and Research (CDER) of the Food and Drug Administration will give the keynote address on Duality of significance test and confidence interval in drug development. 

This event is intended for researchers from pharmaceutical companies, contract research organizations (CROs), regulatory agencies and educational institutions.   The Department recognizes the following sponsors for this symposium:  Abbvie, Boehringer-Ingelheim, Parexel and Quintiles.   For more information, please see our Fall Symposium page

Susan Halabi, Part of Cross Disciplinary Team to receive a Challenge Award to Study Treatment for Lethal Prostate Cancer

March 10, 2015

The Prostate Cancer Foundation (PCF) announced 3 Challenge Awards to support discoveries for the treatment of lethal prostate cancer.  Susan Halabi is part of a cross disciplinary team headed by Thomas Jefferson University that was granted the first 2015 PCF Challenge Award, titled “Optimizing First Line Treatment for Men with Castrate Resistant Prostate Cancer.” This study will examine whether the status of the retinoblastoma gene in tumors can function as a biomarker to determine whether patients with lethal prostate cancer will respond to abiraterone (Zytiga®) or chemotherapy.

The Challenge Awards have a shared goal of putting men with advanced prostate cancer back into longer remission when existing drugs no longer are working. Some men have significant increased survival from prostate cancer treated with chemotherapy; others do not. This study will move research forward on correctly predicting which patient is which. 

PCF Challenge Awards are multi year awards composed of teams of scientists from 3 or more cancer centers. In order to conduct pioneering research, these entrepreneurial scientists require large investments in areas that fall outside the parameters of traditional funding organizations.  These are the first major awards funded by PCF in 2015.  Click here to read more.

Shein-Chung Chow interviewed about biosimilar pharmaceuticals with Michelle Makori of CCTV America

Feb. 18, 2015

 

Ben Goldstein, Senior Author on Study Exploring Donor Heart Shortage

Feb. 11, 2015

Heart disease is the leading cause of death in the United States.  A new study published in the American Journal of Transplantation titled "National decline in donor heart utilization with regional variability: 1995-2010” has found that while the need for heart transplants is rising,  a growing number of surgeons and transplant centers are increasingly rejecting donor hearts.   National trends in donor heart acceptance for transplantation were studied by analyzing data from the Organ Procurement and Transplantation Network for all potential adult cardiac organ donors between 1995 and 2010. There was a significant decrease in donor heart acceptance.   

The analysis also demonstrated regional variability, showing some regions using a relatively higher proportion of donor hearts than others. This suggests that donor heart acceptance practices are not standardized and indicates a need for clinical guidelines for donor heart acceptance, along with more intense efforts to increase the use of donor hearts in areas with relatively low utilization rates.  "Over time heart transplant doctors have gotten pickier about the hearts they transplant but there has been little concordant evidence that this has improved transplant recipient outcomes.  Instead the result has been a larger waitlist with longer waiting times," said Ben Goldstein, a senior author of the study.  

There are currently no standardized, evidence-based donor heart acceptance guidelines in the US.  The study concludes that a more systematic manner of evaluating hearts based on scientific evidence could help increase the number of heart transplants performed.  Click here to read more.

Tim Reddy and Researchers Discover New Protein with link to Gestational Diabetes

Feb. 4, 2015

It has long been accepted that there are four enzymes, called hexokinases, that kick-start the body’s process of metabolizing sugar and getting energy from food.  But according to ground breaking research by scientists at Duke and Northwestern universities, the hexokinase team actually has a fifth player.  “This swims against the past 40 years of research and what we thought we knew, hexokinases are critical to basically all of our energy production. Finding a fifth one opens the door to more study into how we metabolize sugar, as well as genetic links to metabolic disorders.” said Tim Reddy, Ph.D., a senior author of the study. 

The new protein is called HKDC1, and the researchers report that this enzyme may be a genetic predictor for whether an expectant mother develops hyperglycemia during pregnancy. Hyperglycemia is a potentially harmful environment for a growing fetus and can contribute to obesity and diabetes later in the child’s life. Researchers hope the new findings could lead to a test for pregnant women that indicates their potential for developing hyperglycemia.  “The discovery of this gene creates a path forward to better predicting a woman’s risk,” Reddy said. “Knowing that there is this new hexokinase at play could also give us more information on how to inhibit or activate it, and anything we can to do disrupt the cycle would be an important advance to stem the epidemic of diabetes we see today.”

The findings appear in the online journal Nature Communications.  Click here to read more.

Michael Pencina leads a study showing that long-term moderate elevation of cholesterol greatly increases risk of cardiovascular disease
 

January, 2015

This week, Circulation published an article “Hyperlipidemia in Early Adulthood Increases Long-Term Risk of Coronary Heart Disease” that is getting wide circulation in the print, radio and online media. The article is based on research that suggests that even moderate elevation of cholesterol levels in adults between the ages of 35 and 55 can have long-term impact on their heart health, with every decade of high cholesterol increasing their chances of heart disease by 39 percent.  The study, conducted by colleagues at Duke, Boston University and McGill University examined data on 1,478 adults who were free of heart disease at age 55 who were part of the Framingham Heart Study, which began in 1948.  "Few, if any, studies have gathered the quality of the cardiovascular data that the Framingham study has," said biostatistician Michael Pencina, Ph.D., a senior author of the paper. "That wealth of data collected over time made it possible to analyze the long-term effects of cholesterol in young people -- a topic on which not enough is known because it requires decades of tracking."Researchers calculated the length of time each participant had high cholesterol by age 55 and they were followed for up to 20 years to see how cholesterol levels affected their risk of heart disease.  “Dr. Robert Eckel, past president of the American Heart Association, said if these new results are confirmed in future studies, it could influence guidelines on the use of cholesterol-lowering statin drugs.”  Click here to read more.

Second Annual GlaxoSmithKline-Duke Workshop a Rousing Success

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. For more information, please see our News and Updates Section.

Shuyen Ho (GSK), Margaret Polinkovsky (GSK), Sara Hughes (VP and Head, Clinical Statistics of GSK), Greg Campbell (Director, Division of Biostatistics, Center for Devices and Radiological Health, Food and Drug Administration) Liz DeLong (Chair, Duke Department of Biostatistics and Bioinformatics), Shein-Chung Chow (Duke), Xiaofei Wang (Duke)

Chair Liz DeLong signs MOU with National Institutes for Food and Drug Control (NIFDC) of China Food and Drug Administration

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. 

 

Susan Halabi elected Fellow for the Society of Clinical Trials

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."

 

Michael Pencina and other Duke Researchers cited for Influence

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.