Research Practitioner articles from January 2005

Research Practitioner archives from January 2005

From the editors.(Editorial)
January 1, 2005... Clinical research is increasingly in the news and very often the reports relay sensational and problematic situations in the field. Ultimately, this negative publicity will take its toll by instilling distrust and fear in the general public,...

In the news.(issues of FDA recent drug approvals and withdrawals)
January 1, 2005... Drug safety recap The past few months have been a roller coaster ride for observers of drug safety. The news media have produced almost daily reports on drug withdrawals, health alerts, Congressional hearings on drug safety,...

A public health need: informing and engaging stakeholders on the periphery of the clinical research enterprise.
January 1, 2005... Although most Americans believe that clinical research is important for advancing medical knowledge, very few know where to find information about relevant clinical trials. There is a need for greater public awareness in the clinical research...

Best practices in patient enrollment.
January 1, 2005... Patient enrollment is one of the most challenging and costly components of clinical trials. Developing and implementing a patient-focused health communications program starting with protocol design end going through the clinical trial is...

Continuing education.
January 1, 2005... Instructions Continuing Nursing Education 1. Read the articles: A public health need: Informing and engaging stakeholders on the periphery of the clinical research enterprise and Best practices in patient enrollment. 2. Using...

AAHRPP accreditation: a means for participant involvement.(Issues In Human Subjects Protection)(Association for the Accreditation of Human Research Protection Programs, Inc)
January 1, 2005... Note: The standards printed on page 23 were provided by the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP) for Research Practitioner subscribers. Additional resources can be found on the AAHRPP web site...

FDA announces advisory committee schedule for 2005.(Regulatory Update)(Brief Article)
January 1, 2005... In the Dec. 20, 2004, Federal Register, the Food and Drug Administration (FDA) announced a tentative schedule of forthcoming meetings of its public advisory committees for 2005. Because the schedule is tentative, changes to this schedule will...

Advisory committee on human research protections meeting announced.(Regulatory Update)(Brief Article)
January 1, 2005... In the Dec. 16, 2004, Federal Register, the Department of Health and Human Services (HHS) announced an upcoming meeting of the Secretary's Advisory Committee on Human Research Protections (SACHRP). The meeting will be held on Jan. 31, 2005,...

FDA notice of pilot project for nonclinical and clinical datasets.(Regulatory Update)
January 1, 2005... FDA's Center for Biologics Evaluation and Research (CBER) is seeking volunteers to participate in a pilot project involving the evaluation of various analysis tools to facilitate the use of electronic datasets. The datasets will analyze...

FDA draft guidance on using HIV drug resistance tests for drug development.(Regulatory Update)
January 1, 2005... In the Nov. 29, 2004, Federal Register, FDA announced the availability of a draft guidance for industry titled, Role of HIV Drug Resistance Testing in Antiretroviral Drug Development. This draft guidance is intended to assist sponsors in the...

FDA draft guidance on CMC information for gene therapy IND applications.(Regulatory Update)(Brief Article)
January 1, 2005... In the Nov. 9, 2004, Federal Resister, FDA announced the availability of a draft guidance document titled, Guidance for FDA Review Staff and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human...

FDA draft guidance on clinical studies in the presence of genetic toxicology.(Regulatory Update)(Brief Article)
January 1, 2005... In the Dec. 2, 2004, Federal Register, FDA announced the availability of a draft guidance for industry titled, Recommended Approaches to Integration of Genetic Toxicology Study Results. This draft guidance is intended to inform industry on...

CBER medical device warning letters to clinical investigators.(Regulatory Update)(Center for Devices and Radiological Health)
January 1, 2005... Two recent warning letters from FDA's biologics bioresearch monitoring group are instructive in that they show the kinds of problems that plague clinical investigators involved in medical device clinical trials. These letters are presented in...

CDRH medical device sponsor warning letter.(Regulatory Update)(Center for Devices and Radiological Health)
January 1, 2005... FDA's Center for Devices and Radiological Health (CDRH) issued an Oct. 4, 2004, warning letter to a medical device company in Centerville, Mass. The letter was issued to the company as a sponsor and a monitor of medical device investigations,...