|May 2002 (Volume 9, Issue 5)
Article 265: Inside the Informed Consent Process
- Following their reviews of informed consent forms, clinical trial volunteers report that they understand the study requirements and that they can withdraw at any time. Still, a high percentage do not understand research risks, study design and the recourse available to them. Surprisingly, one out of seven volunteers report that they do not even read the informed consent form prior to giving their consent. And the vast majority of volunteers decide to participate on their own without input from advocates or trusted professionals.
Article 266: Pediatric Market Under Scrutiny
Article 267: CentreStage Europe: And the Winners Are... Aventis, Pharmacia, AstraZeneca and Bayer
- The FDA's 1998 Pediatric Rule has been at the center of much controversy lately. It appears, however, that the exclusivity incentive and now a new off-patent drug program may be bigger drivers of pediatric research growth. These factors are expected to stimulate a modest market expansion that may make the Pediatric Rule unnecessary.
Article 268: Eye On Melanoma
- The results are in for the 2002 CenterWatch survey where European investigative sites rate the quality of their relationships with sponsors with whom they have worked. Overall, it is not a particularly flattering picture. This news comes at a time when sponsors are looking to improve development efficiencies through their collaborations with investigative sites.
- CenterWatch Drug Intelligence has identified a clinical drug pipeline of 39, accounting for $150 million to $250 million in clinical spending.