Clinical Trials Administrator Archives – April 1, 2007
April 1, 2007
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NIH grant creates opportunities and supports new trial practices
The clinical trials industry has reaped a variety of benefits from the federally-funded Rare Diseases Clinical Research Network (RDCRN), including the creation of dynamic partnerships between investigators and patients/advocates, according to Charles Strange, MD, a professor of pulmonary and critical care medicine at the Medical University of South Carolina in Charleston. -
Efficiencies resulting from rare disease network
Researchers studying rare diseases have disadvantages in obtaining data that some have learned how to turn into assets. -
Research, treatment benefit from NIH grant and network
Many patients and families coping with a rare disease are offered some hope in the long term because of the research generated in the Rare Diseases Clinical Research Network (RDCRN), which was launched in 2002 by the National Institutes of Health (NIH) and $71 million in funding awards. -
Compliance Corner: More efficient systems improve site compliance
Research sites need to document their contract negotiating positions in policies and then give staff the authority to act on their own within those guidelines, states Kris Rhodes, MS, CRA, director of grants administration for Wake Forest University Health Sciences of Winston-Salem, NC. -
NIH offers this guidance about change in scope
The National Institutes of Health (NIH) offers this information about change in scope, via the NIH Grants Policy Statement: -
Sponsors, others trying new trial methodology
Clinical trial sites may soon see more studies with adaptive designs, reflecting the industry's movement toward a more efficient clinical trial process and a growing trend of treatments targeted to specific groups and populations. -
Improve project management by following best practices
Clinical trial sites can develop solid relationships with sponsors and improve their accuracy with study budgets if they put in the up-front work and time, an expert says.