A clinical trial funded by the National Institutes of Health has studied the safety of treatment with the antibiotic isoniazid to prevent tuberculosis (TB) in women who are living with HIV, are pregnant or have recently given birth, are taking antiretroviral therapy (ART), and live where TB is highly prevalent. The trial found that whether the treatment was begun during pregnancy or 12 weeks after delivery, it was similarly safe for the women. However, there was significantly greater risk of poor health outcomes and death for the fetuses and newborns of these women if isoniazid preventive therapy began during pregnancy than if it began 12 weeks after delivery. This finding is concerning and merits research into alternative approaches to TB preventive therapy in pregnant women, according to the study investigators. These findings are reported in the Oct. 3 issue of The New England Journal of Medicine.
Ting-Li Lin joined Frontier Science Foundation Madison office as a Research Scientist in 2017. He serves as a scientific lead for the Madison office on statistical related matters, and is involved in reviewing, producing, and presenting IDMC monitoring reports. He assists the Madison office director in advising the staff statisticians and overseeing the statistical operations of the Madison office, and provides statistical support to other Frontier Science offices as needed.
At the IMPAACT Network Annual Meeting held in Washington, DC June 2019, Laura Smith, MPH, IMPAACT Chief Data Manager, co-presented a poster entitled IMPAACT Gender Identity Assessment: Site Survey Results & Implementation along with colleagues Susannah Allison, PhD, Miriam Chernoff PhD, and Rona Siskind, MHS.
The Frontier Science Foundation Board of Directors has approved a new Chief Executive Officer position and has named Sue Siminski, currently the Foundation’s Executive Director, as the Foundation’s Chief Executive Officer (CEO) effective July 1st.
The Collaborating Consortium of Cohorts Producing NIDA Opportunities (C3PNO) is pleased to announce the launch of its Virtual Data Repository. C3PNO is the coordinating center for NIDA longitudinal cohorts that represent a combined sample size of about 12,000 active and 20,000 historical participants. C3PNO links behavioral and biological data from cohorts spanning the United States and Canada that follow a diverse group of high risk HIV-negative and HIV-positive persons in and out of care.
Dr. Kathryn P. Gray joined Frontier Science Foundation as Director of Biostatistics and Boston Office Director on March 1, 2019. Dr. Gray has been working in collaborative cancer clinical research, with the focus on gynecologic, breast, renal and prostate cancers, since 2010. She enjoys collaborating with investigators from multiple disciplines on clinical trial and translational studies with the goal of developing personalized cancer treatments.
Frontier Science began its PHIA collaboration with ICAP at Columbia University in 2015 by providing LDMS installations, user support, training, and central database services across 14 mostly sub-Saharan countries in support of the Population-based HIV Assessment (PHIA) project. These countries include: Cameroon, Cote d’Ivoire, Ethiopia, Haiti, Kenya, Lesotho, Malawi, Namibia, Rwanda, Swaziland, Tanzania, Uganda, Zambia, and Zimbabwe. PHIA surveys are implemented under the leadership of each country’s Ministry of Health and by the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR), CDC, and by ICAP at Columbia University. In 2017 Frontier Science also began a collaboration with the University of Maryland School of Medicine on the PHIA Nigeria study (NAIIS).
Michael Bretthauer, MD, PhD, President, Frontier Science, Frontier board members Hans-Olov Adami and Mette Kalager, along with their colleagues Unnur Valdimarsdottir and John P.A. Loannidis have published an editorial in the European Society for Clinical Investigation titled “Time to abandon early detection cancer screening.”
Howard Gutzman, Program Director for the Laboratory Data Management System (LDMS), has worked at Frontier Science for fourteen years. Howard began his career at Frontier Science as a lab data manager for the Adult and International Maternal Pediatric Adolescent HIV Clinical Trials networks and was a member of the LDMS training team. Within three years, Howard was promoted to a Project Manager within Frontier’s lab division and took on additional responsibilities in overseeing the LDMS related projects.
A 2-day course on scientific writing in medicine, “How To Get Your Research Published In The Best Journals” has been scheduled for 13-14 May 2019 in Oslo, Norway. The course is intended for clinicians and researchers with some experience in medical writing or with an interest in learning to write or review scientific papers. Researchers who want to get results published in a respected scientific journal will learn how to prepare a manuscript in order to increase its chance of being accepted for publication in leading journals.
The Journal of Acquired Immune Deficiency Syndrome (JAIDS) recently published an article from investigators of the Pediatric HIV/AIDS Cohort Study (PHACS) that outlines the researchers’ experience using the National Death Index (NDI) to identify if any lost to follow-up study participants occurred due to death among the 4,207 participants enrolled in two PHACS cohorts.
Frontier Science is pleased to welcome two Harvard Fulbright students this year, Lise Helsingen, MD and Paulina Wieszczy as affiliate researchers in our Brookline office.
The core of clinical practice guidelines is the recommendations, and the ideal situation for guidelines is an unequivocal body of evidence about the benefits and harms of different treatment options, and related costs and resources. However, when high quality evidence is lacking, a no guideline recommendation is the best recommendation in clinical practice, according to co-authors Michael Bretthauer, MD, PhD and Mette Kalager, MD, PhD, who published their comments in the September 15th edition of THE LANCET.
Dr. Soyeon Kim, a Senior Research Scientist at Frontier Science Boston, is co-author on an original article, Bacterial Factors in Relapse after Tuberculosis Therapy, published in the August 30, 2018 edition of the New England Journal of Medicine.
Stephen Hart, PhD, a Senior Research Scientist at Frontier Science Foundation (FSF), is the lead author of an article published in the September 1, 2018 edition of the Journal of Acquired Immune Deficiency Syndromes (JAIDS), “Impact of changes over time in the Stanford University genotypic resistance algorithm.” The article comes out of ACTG Data Analysis Concept Sheet (DACS) 330, which Steve designed and led. Sarah Strobino, BS, also from Frontier Science Foundation, made major contributions to the project. Saran Vardhanabhuti, PhD and Linda J. Harrison, MSc, from Harvard T.H. Chan School of Public Health, did the trend analysis.
The 10th International Workshop on HIV Pediatrics, held July 20 to 21, 2018 in Amsterdam, The Netherlands, is entirely devoted to research in prevention and treatment of HIV infections in infants, children and adolescents, making it a premier forum for the world’s leading experts in pediatric, adolescent and maternal HIV research. The 22nd International AIDS Conference, also held in Amsterdam, from July 23 to 27, is the world’s largest conference on AIDS, biennially bringing together leading experts to advance knowledge about HIV. Several networks with whom Frontier Science collaborates, including the IMPAACT, ACTG, and PHACS networks, were highlighted in Amsterdam this year, and Frontier Science was acknowledged as one of the affiliated organizations working on the HIV studies.
Dr. Soyeon Kim, Senior Research Scientist, joined Frontier Science Foundation Boston office in September 2017. Soyeon has worked in the design, analysis, monitoring, and reporting of clinical research studies with International Maternal Pediatric Adolescent AIDS Clinical Trials Network (IMPAACT) and its predecessor Pediatric AIDS Clinical Trials Network, as well as investigator-initiated projects, for more than 20 years. She enjoys working in multidisciplinary teams, closely collaborating with investigators to design trials of clinical and public health significance.
Michael Bretthauer, Frontier Science Foundation President, has announced key features of a new business development plan for Frontier Science in the coming years that will maintain and develop current business platforms and areas, and explore and establish more diverse funding sources and collaborations. The first step in this future development plan is the establishment of a leadership structure to meet the opportunities ahead, including a new Executive Director.
A Norwegian pilot study published in the June 2, 2018 edition of the New England Journal of Medicine shows that a supply of intestinal bacteria can be better than antibiotics for all patients with Clostridium difficile Infection, including those who have it for the first time. The study, Fecal Microbiota Transplantation for Primary Clostridial Difficile Infection examined whether the intestinal bacterial infections of a healthy person (fecal microbial transplantation) can restore a healthy and resilient intestinal flora so that the patient with C Diff infection can get rid of the infection without resorting to antibiotics.
Frontier Science Amherst staff presented two posters at the Society For Clinical Trials 2018 annual meeting. A Unique Collaboration for a Data Coordinating Center outlines the INVESTED collaboration between the University of Wisconsin-Madison and the Frontier Science Data Management Center. Calculating Antiretroviral Drug Resistance: An Innovative Open-Source Tool showcases an antiretroviral drug resistance calculations tool developed at Frontier Science that uses customizable algorithms.
The Collaborating Consortium of Cohorts Producing NIDA Opportunities (C3PNO) invite you to attend an IAS pre-conference in Amsterdam, the Netherlands, on July 22 from 12-2pm CET entitled Blood, Guts & Glory: HIV & Substance Use Research Opportunities Using the C3PNO Virtual Repository to Link NIDA Cohort Data.
C3PNO, the data coordinating center for the National Institute on Drug Abuse (NIDA) longitudinal HIV cohorts, will demonstrate and discuss opportunities related to the new C3PNO virtual repository which links laboratory, clinical, substance use, behavioral, and biological data. The C3PNO goal is to stimulate research with outside investigators and encourage new collaborations with international cohorts studying substance use in the context of HIV pathogenesis. Representatives from Frontier Science will include: Dr. Soyeon Kim, Senior Biostatistician, Adina Stoica, Software Project Manager and Sue Siminski, Co-Principal Investigator.
Members of the Norwegian Colorectal Cancer Prevention Study Group (NORCCAP), including Michael Bretthauer, Frontier Science President, and Mette Kalager, MD, PhD, Board Member, have authored a study published April 24, 2018 in the Annals of Internal Medicine, Long-Term Effectiveness of Sigmoidoscopy Screening on Colorectal Cancer Incidence and Mortality in Women and Men: A randomized trial. The study objective is to determine the effectiveness of flexible sigmoidoscopy screening after 15 years of follow-up in women and men.
The Frontier Science Independent Statistical Center, or ISC, has launched a new website at http://www.fstrf-isc.org. The website outlines the Frontier Science ISC areas of expertise and experience, and the graphical reporting style of the ISC.
Frontier Science is pleased to announce C3PNO, a partnership with the University of California, Los Angeles (UCLA) to stimulate new research in the areas of HIV/AIDS infection in the context of substance abuse.
Laurie Dooley Butler, Data Manager for the Pediatric HIV/AIDS Cohort Study (PHACS)
Our “Employee Spotlight” shines on Laurie Dooley Butler, Data Manager for the Pediatric HIV/AIDS Cohort Study (PHACS). Laurie has worked at Frontier Science for fourteen years. She has an undergraduate degree in Medical Technology from Daemen College, and an MBA from the State University of New York at Buffalo.
Announcing the 2018 DFCI/FSTRF Marvin Zelen Memorial Symposium, to be held on Friday April 6, 2018 from 1:00-6:00pm at the Dana-Farber Cancer Institute.
The topic this year is Data Science in Biomedical Research.
Speakers for this year include:
- Barbara Englehardt, Ph.D., Assistant Professor, Department of Computer Science, Princeton University
- Jeffrey Leek, Ph.D., Associate Professor, Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health
- Steve Goodman, M.D., MHS, Ph.D., Professor of Medicine and of Health Research and Policy, Stanford University
- JJ Allaire, Founder and CEO of RStudio
- Fernanda Viegas, Co-leader, Google’s “Big Picture” Data Visualization Group
- Jayashree Kalpathy-Cramer, Associate Professor of Radiology, Massachusetts General Hospital
Meredith Regan, Sc.D., Director of the Statistical and Data Management Center for the International Breast Cancer Study Group (IBCSG) and co-lead for the IBCSG TEXT and SOFT Trials, visited Frontier Science to present the results of several trials. These results were recently presented during the San Antonio Breast Cancer Symposium (SABCS 2017).
Jamie Hoel, MS, has been named the new Director of the Madison Office of Frontier Science, President Michael Bretthauer announced today. “I am absolutely convinced that Jamie will fill this important role with success, and ask you to welcome him and support him the best you can in his new position,” said Dr. Bretthauer.
Lynette Blacher, Director of Data Management for the International Breast Cancer Study Group (IBCSG)
We are pleased to present a new “Employee Spotlight” series at the Frontier Science website. Lynette Blacher, Director of Data Management for the International Breast Cancer Study Group (IBCSG), has worked at Frontier Science for twenty years. Her educational background includes an undergraduate degree in Psychology and a Masters in Information and Library Science (MLS), both from the State University of New York at Buffalo.
On November 22, the U.S. Food and Drug Administration (FDA) approved updates to the label for raltegravir (also known by the brand name Isentress). This change expands the patient population to include HIV-1 exposed full term neonates from birth to four weeks of age.
Raltegravir is a potent and selective HIV-1 integrase inhibitor. It is used as a treatment for HIV/AIDS, and can also be used as part of a post exposure prophylaxis (PEP).
The change to the label was based on data from the International Material Pediatric Adolescent AIDS Clinical Trials Group (IMPAACT) study P1110. Frontier Science, along with the Harvard T.H. Chan School of Public Health, provide data management and statistical support for this study. The quote below is from the the IMPAACT announcement.
In a December 6, 2017 editorial on Breast cancer screening in The BMJ, Frontier Science board member and Associate Professor at University of Oslo Clinical Effectiveness Research Group, Dr. Mette Kalager, looks at studies analyzing data on breast cancer mortality, mammography screening, and over-diagnosis, and references a new study in the same edition at BMJ, Effectiveness of and overdiagnosis from mammography screening in the Netherlands: population based study. BMJ 2017;359:j5224.
Since its inception, Frontier Science has always viewed its statistical data management services as a collaborative effort, helping researchers and investigators understand and best utilize the data that they are using. As part of this commitment, Dr. Michael Bretthauer brings a diverse academic, research, and publication experience into Frontier Science’s core management.