Clinical Trials Administrator Archives – May 1, 2005
May 1, 2005
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Best practices in pediatric clinical trials expand with help of 13 PPRUs
Only 6% of the 80 drugs most frequently used in newborns and infants are labeled for pediatric use, and three out of four of all medications on the market do not have approved labeling for children. -
How to improve pediatric recruiting and retention
The University of Louisville (KY), is a new participant in the Pediatric Pharmacology Research Units (PPRU) network, but the site has history of success in recruiting and retaining pediatric clinical trial participants. -
Reach subjects through targeted recruiting
Theres a lot of focus on informed consent and compliance with human subject protection regulations. In the clinical trial process, that comes later. What comes first is getting people to volunteer for the trial. -
Informed consent kits improve process globally
Investigators conducting HIV prevention research among married women in developing countries have found that standard informed consent forms and methods do not work for both cultural and comprehension reasons. A more creative approach to informed consent could help improve comprehension, says behavioral scientist Cynthia Woodsong, PhD. -
Compliance Corner: Good documentation helps when FDA knocks on door
While the FDAs enforcement efforts in the clinical trial industry has not changed much over the years, one reality remains: Many clinical trial site staff and administrators do not fully appreciate the consequences of noncompliance, an FDA enforcement expert says. -
News Brief: Health officials testify before House committee
Pandemic flu preparations already are under way, said government health officials who testified in mid-April before a congressional subcommittee.