NIH Launches New Website About “Clinical Research Trials and You”

The National Institutes of Health has created a new website, NIH Clinical Research Trials and You to help people learn more about clinical trials, why they matter, and how to participate. From the first cure of a solid tumor with chemotherapy to the use of nitroglycerin in response to heart attacks, clinical research trials — or research studies involving people — have played a vital role in improving health and quality of life for people around the globe.

Clinical trials are essential for identifying and understanding ways to prevent, diagnose, and treat disease. Research has shown that among the greatest challenges to recruitment of volunteers is the lack of general knowledge about what trials involve, where they are carried out, and who may participate.

“The ability to recruit the necessary number of volunteers is vital to carrying out clinical research that leads to health and medical advances,” said NIH Director Francis S. Collins, M.D., Ph.D. “This new, centralized resource will make it much easier for the public and health professionals to learn about clinical trials and how people can participate in them.”

Visitors to the website will find information about:

• The basics of clinical trial participation
• First hand experiences from actual clinical trial volunteers
• Explanations from researchers
• Links on how to search for a trial or enroll in a research matching program

In addition, health care professionals can read about evidence-based strategies for talking with patients about trials, print audience-tested posters to help promote trials in clinics and offices, and find other educational materials.

Source: NIH News Release

WSU & PHP Announce Clinical Trials Research Alliance (CTRA)

Wright State University Boonshoft School of Medicine, Wright State Research Institute and Premier Health Partners announced today the formation of the Wright State University & Premier Health Partners Clinical Trials Research Alliance to increase medical research opportunities for physicians and clinicians and boost access to clinical trials in the Dayton region.

This major public-private initiative partners the Dayton region’s strongest biomedical research institution with the clinical resources of the region’s leading hospital system. Premier Health Partners is making a major investment of $4 million over five years to support the infrastructure of the alliance. It is expected to build a $5 million to $7 million annual clinical research portfolio over five years, roughly doubling the total of what the medical school and Premier have today.

The National Institutes of Health, other federal sources and pharmaceutical, biotechnology and medical device companies spent $94 billion on research and development in 2008, according to Center Watch, the leading source of clinical trials information for both clinical research professionals and patients.

The Wright State Research Institute will lead the alliance’s development, providing business infrastructure and administrative support, as well as building a pipeline for new research projects. The administrative support will free doctors and researchers at both Wright State and Premier from much of the extensive paperwork and bureaucracy that can discourage doctors from pursuing clinical research projects, said Ryan Fendley, institute director.

The alliance will be established from existing facilities at Wright State and initially with Miami Valley Hospital and Good Samaritan Hospital as the Premier hospitals, but will be available to all PHP hospitals and practices in the future.

Arthur S. Pickoff, M.D., professor and chair of the medical school’s Departments of Community Health and Pediatrics, and assistant dean for clinical research, will direct the alliance.

“We anticipate this will be a game-changer for clinical research in the Dayton region,” Pickoff said. “This research alliance will give the residents of the Dayton region and beyond the opportunity to participate in a large number of cutting-edge clinical trials, which will result in the development of the medical treatments and cures of tomorrow.” Read more.

For more information about clinical trials, see ClinicalTrials.gov.

Pickoff Named Assistant Dean for Clinical Research

Wright State University Boonshoft School of Medicine has appointed Arthur Pickoff, M.D., assistant dean of clinical research.

A faculty member with the medical school since 1999, Pickoff is chair and professor of both the Department of Pediatrics and the Department of Community Health, positions he will retain upon assuming his new leadership role on January 1, 2011.

As assistant dean, Pickoff will lead efforts to enhance and expand the medical school’s flourishing clinical and translational research enterprise. Unlike basic science research, which is often laboratory-based and designed to advance medical knowledge, clinical research tends to take place in hospitals or clinics and focuses on patients and treatments. Translational research, which bridges basic and clinical research, seeks to apply laboratory discoveries to improve patient care, accelerating the path from “bench to bedside.”

In his new role, Pickoff will work closely with the associate dean of research, faculty researchers, department chairs, center directors and representatives of affiliated hospitals and laboratories across the Dayton region. He will promote and support the university’s research centers of excellence, industry- and government-sponsored clinical trials, collaborative research by scientists and clinicians and research within Wright State residency and fellowship programs. He will also oversee biostatistics and IT support, recruitment, training and compliance issues for clinical researchers.

A native of New York City, Pickoff graduated from Queens College with a bachelor’s degree in chemistry, earned his medical degree from Albert Einstein College of Medicine and completed his pediatrics residency at Mt. Sinai Hospital. He then left the city for the University of Miami, where he completed a fellowship in pediatric cardiology and a National Institutes of Health postdoctoral program in cardiac electrophysiology.

Pickoff remained with the University of Miami as a faculty member in pediatrics and radiology until 1987, when he accepted a position at Tulane University as professor of pediatrics and director of pediatric cardiology. He came to Wright State from Tulane in 1999 to serve as professor and chair of pediatrics. In 2005, he received a dual appointment as professor and chair of community health.

Pickoff currently practices and teaches at the Children’s Medical Center of Dayton, where he also serves on the hospital’s professional staff executive committee and board of trustees. He is a member of numerous professional organizations, including the American Medical Association, the, the American Academy of Pediatrics, the Society for Pediatric Research, and the American Federation for Clinical Research. In addition, he is a Fellow of both the American Heart Association and the American College of Cardiology.

FDA Workshop on Cell and Gene Therapy Clinical Trials Scheduled Nov. 2

The U.S. Food and Drug Administration (FDA) will hold a one-day Public Workshop on “Cell and Gene Therapy Clinical Trials in Pediatric Populations” on November 2, 2010, in Bethesda, MD.  The purpose of the workshop is to gather information from Institutional Review Boards (IRBs), gene and cellular therapy clinical researchers, and other stakeholders regarding best practices related to cell and gene therapy clinical trials in pediatric populations, as well as challenges and considerations in the review of these clinical trials. Read more.