 |
|
New study spotlights National Institutes of Health grant outcomes for clinical research
July 28, 2008Need to enhance clinical research enterprise
Although the need to translate basic science discoveries into the clinical arena is widely acknowledged, a new study by researchers at the Medical College of Wisconsin, in Milwaukee, and National Institutes of Health (NIH) identified reasons why clinical science grant applications receive less positive peer reviews than basic science grant applications to the NIH. The findings were published in the July issue of The American Journal of Medicine.
In collaboration with Michael R. Martin, Ph.D., and Teresa Lindqusit, MS, at NIH's Center for Scientific Review CSR), Dr. Theodore Kotchen, associate dean for clinical research and professor of medicine at the Medical College, studied 92,922 grant applications submitted to NIH between October 2000 and May 2004. Of that number, 67.5 percent were considered basic science applications and 32.5 percent were considered clinical applications. Dr. Kotchen is special advisor on clinical research to the NIH's CSR.
They found that investigators conducting clinical research were less likely to submit a continuing, competitive renewal grant application than investigators conducting basic research (20.0% vs. 28.3%). However, renewal applications generally receive more favorable reviews than new applications. The study concluded that approximately one-half of the observed differences in peer review outcomes for clinical versus basic research applications can be attributed to the lower rate of resubmission by clinical applicants.
Another reason for differences in review outcomes was related to applicants failing to adequately address human subject concerns in their applications. Human subject concerns, which the NIH defines as any potential or actual unacceptable risk or inadequate protection against risks to human subjects, were identified in 15% of clinical grant applications.
"Applications cited for having human subject concerns do not necessarily mean that the science is less meritorious," says Dr. Kotchen.
"Human subject concerns raised at the time of review may reflect inadequate explanation by the investigator in the protection of human subjects section of the application. Further instructions clarifying how to complete the human subject section of grant applications may be necessary.
"The message to applicants is that failure to provide complete information about plans for protecting human subjects may result in a less favorable priority and could adversely affect the likelihood of funding."
According to Kotchen, "There are continuing national concerns about the robustness of the clinical research enterprise. This includes a shortage of clinical investigators, the attrition of experienced clinical investigators, lack of adequate infrastructure at academic medical centers, and the financial burden faced by promising young scientists."
He points out that, "The clinical research enterprise would benefit from an informed understanding of the factors contributing to the attrition of experienced clinical investigators."
Clinical research grants were defined as any grants that include involvement of human subjects. This definition includes research on mechanisms of disease, therapeutic interventions, clinical trials, development of technologies, epidemiological and behavioral studies outcomes, and health services research.
Medical College of Wisconsin
They found that investigators conducting clinical research were less likely to submit a continuing, competitive renewal grant application than investigators conducting basic research (20.0% vs. 28.3%). However, renewal applications generally receive more favorable reviews than new applications. The study concluded that approximately one-half of the observed differences in peer review outcomes for clinical versus basic research applications can be attributed to the lower rate of resubmission by clinical applicants.
Another reason for differences in review outcomes was related to applicants failing to adequately address human subject concerns in their applications. Human subject concerns, which the NIH defines as any potential or actual unacceptable risk or inadequate protection against risks to human subjects, were identified in 15% of clinical grant applications.
"Applications cited for having human subject concerns do not necessarily mean that the science is less meritorious," says Dr. Kotchen.
"Human subject concerns raised at the time of review may reflect inadequate explanation by the investigator in the protection of human subjects section of the application. Further instructions clarifying how to complete the human subject section of grant applications may be necessary.
"The message to applicants is that failure to provide complete information about plans for protecting human subjects may result in a less favorable priority and could adversely affect the likelihood of funding."
According to Kotchen, "There are continuing national concerns about the robustness of the clinical research enterprise. This includes a shortage of clinical investigators, the attrition of experienced clinical investigators, lack of adequate infrastructure at academic medical centers, and the financial burden faced by promising young scientists."
He points out that, "The clinical research enterprise would benefit from an informed understanding of the factors contributing to the attrition of experienced clinical investigators."
Clinical research grants were defined as any grants that include involvement of human subjects. This definition includes research on mechanisms of disease, therapeutic interventions, clinical trials, development of technologies, epidemiological and behavioral studies outcomes, and health services research.
Medical College of Wisconsin
Clinical Research Current Events and Clinical Research News RSSTeam finds breast cancer gene linked to disease spread
A team of researchers at Princeton University and The Cancer Institute of New Jersey has identified a long-sought gene that is fatefully switched on in 30 to 40 percent of all breast cancer patients, spreading the disease, resisting traditional chemotherapies and eventually leading to death.
New appropriate use criteria guide treatment of patients with heart blockage
If you're committed to fitness, the decision to climb a couple of flights of stairs rather than take the elevator is clear. But if you develop chest pain on the way up, deciding how to treat the symptoms of clogged arteries in your heart is much more complicated.
Nutrigenomics -- developing personalized diets for disease prevention
The emerging field of nutrigenomics, which aims to identify the genetic factors that influence the body's response to diet and studies how the bioactive constituents of food affect gene expression.
Common Treatment for Chronic Prostatitis Fails to Reduce Symptoms
Alfuzosin, a drug commonly prescribed for men with chronic prostatitis, a painful disorder of the prostate and surrounding pelvic area, failed to significantly reduce symptoms in recently diagnosed men who had not been previously treated with this drug.
Hepatitis C Treatment Reduces the Virus but Liver Damage Continues
Treating patients who have chronic hepatitis C and advanced liver disease with long-term pegylated interferon significantly decreased their liver enzymes, viral levels and liver inflammation, but the treatment did not slow or prevent the progression of serious liver disease, a study finds.
Children's cancer group recommends global evaluation system for neuroblastoma to improve treatment
An international coalition of pediatric cancer physicians and researchers has developed new systems to standardize studies of neuroblastomas across the world.
50 Years Of Hairy-Cell Leukemia Research To Be Observed
In 1958, Ohio State University cancer researcher Dr. Bertha Bouroncle first identified a deadly disease now known as hairy-cell leukemia, a once fatal disease that can now be effectively treated.
Experts discuss applying systematic review to the field of nutrition
Performing systematic reviews of nutrition related topics raises unique challenges not often encountered in the field of medicine. In a new article, a team of researchers use specific examples to describe the steps, strengths, and limitations of systematic reviews relevant to nutrition and discuss the factors that impact the results.
Landmark study defines benefits of early HIV testing and treatment for infected infants
Testing very young babies for HIV and giving antiretroviral therapy (ART) immediately to those found infected with the virus dramatically prevents illness and death, according to a report in the New England Journal of Medicine.
Study Investigates Non-Surgical Placement of a Gore-tex Type Device in the Heart to Stop Recurrent Strokes and Mini-Strokes
A study is under way at Rush University Medical Center using a small, soft-patch device made of a Gore-tex-type material - often used to make durable outerwear - to close a common hole found in the heart called a patent foramen ovale (PFO) in order to prevent recurrent strokes and transient ischemic attacks (TIAs) in adults.
More Clinical Research Current Events and Clinical Research News Articles
 | Foundations of Clinical Research: Applications to Practice (3rd Edition) by Leslie Gross Portney, Mary P. Watkins Provides the foundations that are necessary for finding and interpreting research evidence across all healthcare professions. Revised to reflect the most current changes in the field of clinical research in rehabilitation and medicine, including the growing emphasis on evidence-based practice (EBP) that has become central to all of health care and the new vocabulary that is being... |
 | Research Design in Clinical Psychology (4th Edition) by Alan E. Kazdin In this successful text, Kazdin describes research methods in psychology and provides criteria for conducting and evaluating clinical research. This text's emphasis is on clinical psychology, but the issues and methods it discusses are relevant to counseling, school psychology and psychiatry. The various stages of research are discussed, with an emphasis on the special demands that are placed on... |
 | Designing Clinical Research: An Epidemiologic Approach by Stephen B Hulley, Steven R Cummings, Warren S Browner, Deborah G Grady, Thomas B Newman Designing Clinical Research sets the standard for providing a practical guide to planning, tabulating, formulating, and implementing clinical research, with an easy-to-read, uncomplicated presentation. This edition incorporates current research methodology--including molecular and genetic clinical research--and offers an updated syllabus for conducting a clinical research workshop. Emphasis is... |
 | Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary All investigators funded by the National Institutes of Health are now required to receive training about the ethics of clinical research. Based on a course taught by the editors at NIH, Ethical and Regulatory Aspects of Clinical Research is the first book designed to help investigators meet this new requirement. The book begins with the history of human subjects research and guidelines... |
 | Research Methods in Clinical Psychology: An Introduction for Students and Practitioners by Chris Barker, Nancy Pistrang, Robert Elliott RESEARCH METHODS IN CLINICAL PSYCHOLOGY is a reader-friendly introduction to doing, and thinking about, research for clinical psychologists. This systematic guide takes students and practitioners through the basic steps of a research project, from start to finish. It is an invaluable tool for those who want to conduct their own research, or simply want a better understanding of published... |
 | Principles and Practice of Clinical Research, Second Edition (Principles & Practice of Clinical Research) The second edition of this innovative work again provides a unique perspective on the clinical discovery process by providing input from experts within the NIH on the principles and practice of clinical research. Molecular medicine, genomics, and proteomics have opened vast opportunities for translation of basic science observations to the bedside through clinical research. As an introductory... |
 | Measures for Clinical Practice and Research: A Sourcebook Volume 1: Couples, Families, and Children by Joel Fischer, Kevin Corcoran The fourth edition of this essential resource has dozens of new scales as well as updated information for existing instruments, expanding and cementing its utility for members of all the helping professions, including psychology, social work, psychiatry, counseling, nursing, and medicine. Each instrument is reproduced in its entirety and critiqued by the editors, who provide guidance on how to... |
 | Motor Control: Translating Research into Clinical Practice by Anne Shumway-Cook, Marjorie Hines Woollacott Motor Control is the only text to bridge the gap between current motor control research and its applications to clinical practice. The text prepares therapists to examine and treat patients with problems related to balance, mobility, and upper extremity function, based on the best available evidence supporting clinical practice. The Third Edition features a new two-color design with an updated... |
 | Clinical Research: Concepts and Principles for Advanced Practice Nurses by Manfred Stommel, Celia E Wills Michigan State Univ., East Lansing. Designed to equip nurses with a thorough understanding of the methodological concepts and tools used in evidence-based clinical practice. Provides basic skills in interpreting and using research for the clinical management of patient populations. Specifically written for graduate nursing students.... |
 | Conducting Clinical Research: A Practical Guide for Physicians, Nurses, Study Coordinators, and Investigators by Judy Stone A practical, user-friendly how-to manual for medical professionals that explains how to attract drug companies to a site, land a study, recruit volunteers, coordinate studies, organize clinical trial activities, and navigate regulatory requirements. Extensive section on ethics, social and political issues. Comprehensive appendices offer essential background, resources, sample forms and... |
| © 2009 BrightSurf.com |