Research Practitioner articles from July 2003

Research Practitioner archives from July 2003

From the editors.
July 1, 2003... Clinical studies need to be reviewed for scientific merit as well as for issues surrounding ethical implementation of the protocol. For the usual Phase 1 to 4 drug trial, pharmaceutical company scientists, outside consultants, and U.S. Food...

The lessons of SARS. (In the News).
July 1, 2003... In the 21st century--with global travel, instantaneous communication, and 24-hour news coverage--a new disease can appear, spread, and become a household name almost overnight. Last fall, Severe Acute Respiratory Syndrome (SARS) was a novel...

New ASCO policy. (In the News).(American Society of Clinical Oncology)
July 1, 2003... On April 29, The American Society of Clinical Oncology (ASCO) released new recommendations intended to improve the oversight of cancer clinical trials and to address conflicts of interest in research. The report was developed by a special...

Medical device regulation--then and now.
July 1, 2003... In a 1995 issue of Research Nurse, the predecessor to this journal, author Eileen Rusnak recounted the history of medical device regulation in the United States. In her fascinating review, she wove the story of how medical devices were, or...

Placebo controls in the evaluation of medical devices.
July 1, 2003... The use of placebo controls in randomized clinical trials is widely endorsed from a scientific and statistical perspective, but remains a topic of controversy from an ethical perspective. This paper examines the role of placebo controls in...

Using PDAs to enhance clinical research site operations. (Issues In Clinical Trial Management).
July 1, 2003... The use of hand-held personal digital assistants (PDAs) can enhance study-related activities of clinical research staff and ancillary personnel by providing information in a portable, user-friendly device. Health care providers increasingly...

Public comments on 2 research protocols involving children. (Regulatory Update).
July 1, 2003... The Department of Health and Human Services (HHS) is seeking public comment on 2 research protocols involving children. The notices of these requests were published in the June 13, 2003, Federal Register. Both requests are made in keeping...

HHS waiver for research on prisoners granted. (Regulatory Update).(Brief Article)
July 1, 2003... In an earlier issue of Research Practitioner (Volume 3, Number 6), we described an HHS plan to waive certain human subject protections accorded to prisoners for certain research to be conducted or supported by HHS. The studies for which the...

OHRP guidance on prisoners and research. (Regulatory Update).(Brief Article)
July 1, 2003... On a related note, on May 23, 2003, OHRP issued a "Guidance on the Involvement of Prisoners in Research," which articulates some OHRP policy in this area and provides answers to some frequently asked questions. The guidance memorandum...

FDA extends proposed rule comment period. (Regulatory Update).(Brief Article)
July 1, 2003... The Food and Drug Administration (FDA) proposed rule on "Safety Reporting Requirements for Human Drug and Biologic Products," which was published in the March 14, 2003, Federal Register and described in an earlier issue of Research...

FDA to survey clinical research/informed consent knowledge. (Regulatory Update).(Brief Article)
July 1, 2003... FDA is asking for permission to conduct a survey of consumers' knowledge and attitudes about clinical research and informed consent. To conduct this survey, FDA first must obtain the permission of the Office for Management and Budget, and...

Pediatric expertise required for FDA advisory panels. (Regulatory Update).(Brief Article)
July 1, 2003... FDA's Center for Devices and Radiological Health (CDRH) issued a guidance document titled "Pediatric Expertise for Advisory Panels" on June 3, 2003. In the guidance, FDA describes the procedures by which it will ensure that any premarket...

"Desperately seeking nominees". (Regulatory Update).
July 1, 2003... FDA has issued a call for nominees for several of its medical device public advisory committees and panels in a June 5, 2003, Federal Register notice (pages 33720-33723). Vacancies occur and new members are added throughout the year. FDA...

Publication of responses to FDA warning letters. (Regulatory Update).(Brief Article)
July 1, 2003... Anyone who has received a Warning Letter from FDA knows that the letters are available to the public on FDA's web site. FDA now plans to launch a pilot program in which it also will post on its web site, at the request of the person or...

FDA guidance on pharmacokinetics in patients with impaired hepatic function. (Regulatory Update).
July 1, 2003... In May 2003, FDA released a guidance document on pharmacokinetic (PK) studies in patients with impaired hepatic function. The primary purpose of this guidance is to help sponsors/investigators determine, based on the behavior of a drug in...

Exposure-response relationships and clinical trial design. (Regulatory Update).(Brief Article)
July 1, 2003... FDA released a guidance document in April 2003, titled "Guidance for Industry on Exposure-Response Relationships--Study Design, Data Analysis, and Regulatory Applications." The guidance provides recommendations for sponsors of investigational...

Draft FDA guidance on independent consultants for biotechnology clinical trial protocols. (Regulatory Update).
July 1, 2003... FDA is seeking public comments on a draft guidance titled "Independent Consultants for Biotechnology Clinical Trial Protocols." Comments are sought until August 5, 2003. The May 7, 2003, Federal Register notice indicating the availability of...

Draft FDA guidance on tests for genetic markers and mutations. (Regulatory Update).(Brief Article)
July 1, 2003... There has been much interest and concern about the development and use of tests to detect various genetic markers and their mutations, especially in the potential for abuse of the results obtained from these tests. Nevertheless, manufacturers...

Draft HHS guidance on financial interests in research. (Regulatory Update).(Brief Article)
July 1, 2003... In August 2000, HHS issued a draft interim guidance titled "Financial Relationships in Clinical Research: Issues for Institutions, Clinical Investigators, and IRBs to Consider when Dealing with Issues of Financial Interests and Human Subject...