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: translational research
The Literature Isn’t Just Biased, It’s Also Late to the Party
Animal studies of drug efficacy are an important resource for designing and performing clinical trials. They provide evidence of a drug’s potential clinical utility, inform the design of trials, and establish the ethical basis for testing drugs in human. Several recent studies suggest that many preclinical investigations are withheld from publication. Such nonreporting likely reflects… Continue reading The Literature Isn’t Just Biased, It’s Also Late to the Party
Uncaging Validity in Preclinical Research
High attrition rates in drug development bedevil drug developers, ethicists, health care professionals, and patients alike. Increasingly, many commentators are suggesting the attrition problem partly relates to prevalent methodological flaws in the conduct and reporting of preclinical studies. Preclinical efficacy studies involve administering a putative drug to animals (usually mice or rats) that model the… Continue reading Uncaging Validity in Preclinical Research
How Many Negative Trials Do We Need?
There is a growing concern in the clinical research community about the number of negative phase 3 trials. Given that phase 3 trials are incredibly expensive to run, and involve hundreds or sometimes thousands of patient-subjects, many researchers are now calling for more rigorous phase 2 trials, which are more predictive of a phase 3… Continue reading How Many Negative Trials Do We Need?
Teaching Kills Blogging: Somewhat Recent Developments…
Dear Faithful Readers: Teaching has cut my blogging to a trickle, though the teaching has now begun to taper off. My silence is not for want of major developments in the last two months. Among a few highlights: • Obama picks members for his Bioethics advisory panel: White house recently announced membership of its “Presidential… Continue reading Teaching Kills Blogging: Somewhat Recent Developments…
California Dreamin: CIRM Announces New Stem Cell Awards
California’s Institute for Regenerative Medicine just announced a series of large funding awards to fund translational research initiatives involving (mostly) stem cells. The projects funded are telling with respect to what was funded, and what they will attempt to achieve. First, notwithstanding a press release containing the words “bringing stem cell therapies to the clinic,”… Continue reading California Dreamin: CIRM Announces New Stem Cell Awards
Mice- Three Different Ones: Towards More Robust Preclinical Experiments
One of the most exciting and intellectually compelling talks thus far at the American Society of Gene Therapy meeting was Pedro Lowenstein’s. A preclinical researcher who works on gene transfer approaches to brain malignancies (among other things), Lowenstein asked the question: why do so many gene transfer interventions that look promising in the laboratory fail… Continue reading Mice- Three Different Ones: Towards More Robust Preclinical Experiments
Found Figures: Picking up the Pieces after an HIV Vaccine Trial Fails
In the November 29, 2008 issue of Lancet, two reports (plus a commentary) report the famously disappointing outcome of a recent placebo-controlled study testing adenoviral vector-based vaccines against HIV. News reports over a year ago reported that the study was halted after an interim analysis failed to show any prospect of proving effective. More troubling,… Continue reading Found Figures: Picking up the Pieces after an HIV Vaccine Trial Fails
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