publication date: Apr. 4, 2014


PCORI Forms Clinical Trials Advisory Board

THE PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE appointed 10 members to a new Advisory Panel on Clinical Trials. The panel will convene for its first meeting May 1 in Washington, D.C.

Members of the panel will provide expertise on the design and implementation of randomized controlled trials.

Topics include selection of appropriate patient-centered outcomes, informed consent of study participants, periodic evaluations of the institute’s clinical trial portfolio, and the readiness of trial results for dissemination.

The panelists and four alternates were selected from 231 applicants. More than half are biostatisticians, epidemiologists, or others with technical expertise in conducting clinical trials. Two others represent patients, patient advocates, or family caregivers and another is an expert in the ethical aspects of such studies.

The 10 panelists are:

• Jason Connor, director and senior statistical sat Berry Consultants.

Connor is a biostatistician specializing in Bayesian and adaptive trial design. He currently holds academic appointments as a visiting professor at The Johns Hopkins University Bloomberg School of Public Health and assistant professor at the University of Central Florida College of Medicine.

• Sanford Jeames, adjunct professor at Huston-Tillotson University and coordinator of Health Sciences Program, at Eastside Memorial High School.

Jeames is a community health educator and patient advocate. His interests include health education, cancer prevention, and healthier lifestyle interventions, with a focus on under-served populations. On behalf of NCI, he has served as a protocol reviewer with the Special Emphasis Panel and as a clinical trials reviewer for the Adult Central Institutional Review Board.

• John Lantos, professor of pediatrics at Children’s Mercy Hospital

After 20 years on the faculty of The University of Chicago’s Pritzker School of Medicine, Lantos moved to Kansas City to create and direct a pediatric bioethics center at Children’s Mercy Hospital. His research focuses on the ethics of clinical trials and he has analyzed the ethical issues in neonatology, cancer chemotherapy, renal dialysis, cardiac assist devices, and primary care pediatrics.

• Anne McTiernan, professor at Fred Hutchinson Cancer Research Center and the Schools of Public Health and Medicine at the University of Washington

McTiernan’s research focuses on disease prevention through weight control, physical activity, and chemoprevention. She has led multiple randomized controlled trials testing weight loss, exercise, medications, and supplements, and was the principal investigator of the NCI-funded Seattle Translational Research on Energetics and Cancer.

• Margo Michaels, executive director and founder of the Education Network to Advance Cancer Clinical Trials.

Michaels has developed numerous programs to educate cancer advocates, community leaders, and healthcare professionals about policy and science issues related to cancer. Previously, she served as branch chief at the NCI’s Public and Survivor Education Branch; as the lead consultant to the Clinical Research: Affiliates Funding Trials program at the Susan G. Komen Breast Cancer Foundation; and as the director of the National Breast Cancer Coalition’s Project LEAD.

• Craig Nichols, co-director of the Virginia Mason Medical Center Testicular Cancer Clinic and executive officer of Cancer Prevention and Control.

Nichols’s research focuses on rare malignant diseases and the development of clinical trials focused on cancer. He serves on the boards of several cancer non-profits and has extensive service with the NCI, national and international cancer research organizations, and cancer nonprofit organizations.

• Frank Rockhold, senior vice president of Global Clinical Safety and Pharmacovigilance at GlaxoSmithKline.

Rockhold previously led the GSK Cardiovascular Development and Clinical Safety and Pharmacovigilance Departments. He has held leadership positions focusing on clinical trials, data standards, benefit to risk, clinical research, epidemiology, and most recently, pharmacovigilance.

• Elizabeth Stuart, associate professor of mental health and biostatistics at The Johns Hopkins Bloomberg School of Public Health.

Stuart previously worked on a number of large-scale randomized trials of social interventions as a Researcher at Mathematica Policy Research. Her research interests include statistical issues associated with randomized trials, including handling complexities such as missing data, clustering, mediation analysis, and noncompliance.

• Robert Temple, deputy center director for clinical science at the FDA Center for Drug Evaluation and Research

Temple began his career at FDA in 1972, serving as a reviewer in the endocrine and metabolic division. Since then, he has served as assistant to the center director, with responsibility for final sign-off on Drug Efficacy Study Implementation conclusions, as director of the Cardiorenal Division, as director of the Office of Drug Evaluation, and as director of the Office of Medical Policy.

• Merrick Zwarenstein, director of the Centre for Studies in Family Medicine, Department of Family Medicine, Western University in Ontario, Canada.

Zwarenstein’s research focuses on health care program development and evaluation in Canada and internationally, especially in South Africa, where he holds professorships at Stellenbosch University and the University of Cape Town. His interest focuses on optimizing health care delivery through research on effectiveness.

was named executive vice president of scientific and public affairs at the Intrexon Corporation. The former director of NCI was most recently chairman of Intrexon’s health sector.

Broder will lead the company’s communications programs with media, academia, government, and non-profit organizations, spanning health, food, energy, environment, and consumer sectors.

was named the Richard T. Miyamoto Professor and chair of the Indiana University School of Medicine Department of Otolaryngology-Head and Neck Surgery. Couch will assume her duties June 1, pending approval by the trustees of Indiana University.

A head and neck surgical oncologist, she is professor and interim chair of the Department of Surgery at the University of Vermont College of Medicine and surgeon-in-chief of Fletcher Allen Health Care.

She joined the University of Vermont faculty in 2010 as division chief of otolaryngology-head and neck surgery and was appointed interim chair and physician leader of surgery in 2011. She also served as interim chief of ophthalmology and associate vice president of finance for the UVM Medical Group.

Couch will succeed Richard Miyamoto, chair and Arilla Spence DeVault Professor of Otolaryngology-Head and Neck Surgery and medical director of audiology and speech language pathology.

Miyamoto performed Indiana’s first cochlear implant in 1979. In 1995, he and his team at Riley Hospital for Children implanted a device in a 16-month-old boy, the youngest ever to receive a cochlear implant at that time.

was named the recipient of the David King Community Clinical Scientist Award by the Association of Community Cancer Centers. Award winners become lifetime members of the ACCC National Academy of Community Oncology Scientists.

Powderly is president and founder of Carolina BioOncology Institute, the only oncologist Certified Physician Investigator in the Charlotte, N.C., region, and is an adjunct clinical assistant professor of medicine at Duke University and the University of North Carolina, Chapel Hill.

The association’s award is named after David King, who died after a brief battle with cancer. King served the association in many capacities—as president, chair of the Annual Presidents Retreat, and co-chair of ACCC’s Reimbursement Committee.

 was named the inaugural Joseph W. and Jackie J. Cusick Professor of Oncology and a professor of medicine at the Indiana University School of Medicine. He is also the phase I director and director of the gastrointestinal cancer research program at the IU Simon Cancer Center, and he will represent the cancer center on the Big Ten Cancer Research Consortium steering committee.

O’Neil was most recently an associate professor of medicine and director of the gastrointestinal malignancies research program at the University of North Carolina at Chapel Hill. He also was the medical director of the UNC Lineberger Comprehensive Cancer Center’s clinical protocol office. His area of expertise is in gastrointestinal cancers, with a concentration on pancreas, colorectal, and hepatocellular carcinomas.

The professorship was established by Jackie Cusick in memory of her husband Joseph, who co-founded, co-owned and co-operated NCA Group. He was instrumental in building New Hope Presbyterian Church in Fishers, Ind. It is the intent of the donor that the holder be involved in clinical or basic science research aimed at enhancing treatment for patients with gastrointestinal cancers.

and Caring for Carcinoid Foundation announced up to $300,000 in globally available awards to develop cell lines for intestinal carcinoid and pancreatic neuroendocrine cancer.

These rare cancers have few FDA-approved treatment options. The lack of widely available, validated neuroendocrine cancer cell lines is a major obstacle to neuroendocrine cancer research. The program will feature intestinal carcinoid and pancreatic neuroendocrine cancer as the first awards.

Investigators who create one or more immortal cell lines from intestinal carcinoid and/or pancreatic neuroendocrine tumors are invited to submit the cell line(s) for prompt validation, to establish eligibility, and to initiate the process for repository deposit. Investigators whom the CFCF has funded after 2011 to create cell lines are ineligible for the prize.

Complete submission criteria are available on their website.

received the 2014 Harold M. Weintraub Graduate Student Award sponsored by the Basic Sciences Division of Fred Hutchinson Cancer Research Center.

The recipients, all advanced students at or near the completion of their studies in the biological sciences, will participate in a scientific symposium May 2 at Fred Hutch consisting of scientific presentations by the awardees.

The award recipients will receive a certificate, travel expenses and an honorarium from the Weintraub and Groudine Fund, established to foster intellectual exchange through the promotion of programs for graduate students, fellows and visiting scholars.

The 2014 Harold M. Weintraub Graduate Student Award Recipients follow:

• Andrew Adey, of the University of Washington, Ph.D. in molecular and cellular biology

• Colin Conine, of the University of Massachusetts, Ph.D. candidate in molecular biology and genetics

• Daniel Hochbaum, of Harvard University, Ph.D. candidate in engineering/applied sciences/applied physics

• Hidehiko Inagaki, of the California Institute of Technology, Ph.D. candidate in biology

• Liron Bar-Peled, of the Massachusetts Institute of Technology, Ph.D. in biology

• Nora Pencheva, of The Rockefeller University, Ph.D. candidate in molecular biology

• Alistair Russell, of the University of Washington, Ph.D. candidate in microbiology

• Andrew Stergachis, of the University of Washington, Ph.D. candidate in genome sciences

• Emma Watson, of the University of Massachusetts, Ph.D. candidate in systems biology

• Kipp Weiskopf, of Stanford University, Ph.D. candidate in stem cell biology/regenerative medicine/cancer biology

• Sarah Wilson, of the University of California, Berkeley, Ph.D. candidate in molecular and cell biology

• Jiaxi Wu, of the UT Southwestern Medical Center, Ph.D. candidate in genetics and development

• Swathi Yadlapalli, of the University of Michigan, Ph.D. candidate in cell and developmental biology

released the results of its IV Fluid Shortage Survey. Sixty-six practices from across the country were surveyed. The results showed that:

• 85 percent of the practices surveyed have received warnings from multiple manufacturers and/or have been impacted by the shortage of IV fluids

• 44 percent of the practices surveyed have adjusted how and when fluids are used, are pursuing additional distributors to meet their patients’ needs, and/or are attempting to create excess inventory against further shortages

• Less than 15% of the practices surveyed have made no changes in light of the current or future shortages

The complete survey results, including comments from participants, are available on the COA website.

updated its clinical practice guidelines in oncology for Genetic/Familial High-Risk Assessment: Colorectal.

• For colon cancer, the colonoscopy screening recommendations were changed to “Colonoscopy at age 25-30 y or 2-5 y prior to the earliest colon cancer if it is diagnosed before age 30 y and repeat every 1-2 y” from “Colonoscopy at age 30-35 y (may need to be earlier in some families, depending on ages of cancers observed) every 2-3 y, and then after age 40 y every 1-2 y.”

For extra colonic, 1st sub-bullet was changed to “For endometrial and ovarian cancer, see surveillance for MLH1, MSH2 and EPCAM carriers (See LS-3)” from “Consider prophylactic hysterectomy and BSO in women who have completed childbearing.”

A new clinical testing criteria was added for Lynch Syndrome based on personal and family history: “Consider testing individuals with ≥5% risk of LS on any mutation prediction model (eg, MMRpro, PREMM[1,2,6], MMRpredict).”

In Juvenile Polyposis Syndrome, a new heading title was added called, “Genetic Testing.”

The following bullet was added and revised: “Clinical genetic testing is recommended with approximately 50% of JPS cases occurring due to mutations in the BMPR1A and SMAD4 genes. If known SMAD4 mutation in family, genetic testing should be performed within the first 6 months of life due to hereditary hemorrhagic telangiectasia (HHT) risk.”

“Hemorrhagic Telangiectasia (HHT)” was added to the table with a recommendation, “In individuals with SMAD4 mutations, screen for vascular lesions associated with HHT.” The initiation age was added: “Within first 6 mo of life.”

• In Colonic Adenomatous Polyposis of Unknown Etiology:

Personal history of >10-<100 adenomas: Small adenoma burden manageable by colonoscopy and polypectomy, the sub-bullet for management/surveillance was revised: “Clearing of all polyps is recommended preferable but not always possible.Repeat at short interval if residual polyps are present.”

Personal history of >10- <100 adenomas: Dense polyposis or large polyps not manageable by polypectomy, the management/surveillance was revised: “Subtotal colectomy or proctocolectomy depending on adenoma density and distribution,” and a new bullet was added: “Consider proctocolectomy if there is dense rectal polyposis not manageable by polypectomy.”

For each family history phenotype, “consider” was added to each of the management/surveillance recommendations and a corresponding footnote “b” was added: “There are limited data to suggest definitive recommendations for when to initiate screening or the interval of screening.”

In Peutz-Jeghers Syndrome, MRI was added as a screening procedure option of the small intestine, and age to initiate screening for pancreatic cancer was changed from “25-30 y” to “30-35 y.”

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