As Jonathan is fond of saying: Drugs are poisons. It is only through an arduous process of testing and refinement that a drug is eventually transformed into a therapy. Much of this transformative work falls to the early phases of clinical testing. In early phase studies, researchers are looking to identify the optimal values for the various… Continue reading The Landscape of Early Phase Research
Tag: cell therapy
Stems and Blossoms (part 2): Really Informed Consent
There is a strain within the clinical and bioethics community that takes a minimal view of informed consent: investigators are supposed to provide requisite information to volunteers; if research subjects fail to comprehend this information, pity for them. This view brings to mind a memorable exchange between Inspector Clouseau and a hotel clerk (Clouseau: “does… Continue reading Stems and Blossoms (part 2): Really Informed Consent
Stems and Blossoms (part 1): Justice
Shortly before I left for holiday, the International Society for Stem Cell Research (ISSCR) issued a policy paper, “Guidelines for the Clinical Translation of Stem Cells,” outlining ethical and scientific considerations for researchers designing translational trials involving stem cells (whether stem cell derived, adult, or embryonic). In my opinion, the document wins the award for… Continue reading Stems and Blossoms (part 1): Justice
Soft Cells and C-Sections
The American Society of Gene Therapy is renaming itself: “American Society of Gene and Cell Therapy” (membership has yet to finalize the name change.” The European Society of Gene Therapy has already done so: “European Society of Gene and Cell Therapy.” Why is gene transfer going cellular? The publicly stated reasons are two fold. First… Continue reading Soft Cells and C-Sections
Sell Therapy, European Style
Two side-by-side news reports in the August 21 issue of Nature spell more trouble for cell therapy in Europe. The first story follows on previous reports about Austrian urologist Hannes Strasser (see postings on Jul 23 and May 27, 2008). According to an Austrian government report, Strasser “failed to get appropriate approval for the trial… Continue reading Sell Therapy, European Style
Stemming Medical Tourism (part 1)
The July 17 issue of Nature reports that a patient participating in a Vienna-based cell transfer study for urinary incontinence won a lawsuit against the University Hospital in Innsbruck for not being “told… the procedure was experimental.” The case was described in an earlier post in my blog (May 27, 2008: Bladder Trouble at the… Continue reading Stemming Medical Tourism (part 1)