Research biopsies involve the collection of tissues for scientific endpoints. In the early phase cancer trials, research biopsies are often used to assess the biological activity of a drug on a molecular level. This is called pharmacodynamics – the study of what a drug does to the body at the molecular or cellular level. Because… Continue reading Pharmacodynamic Studies in Drug Development: What you don’t know can hurt you
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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
No trial stands alone
“The result of this trial speaks for itself!” This often heard phrase contains a troubling assumption: That an experiment can stand entirely on in its own. That it can be interpreted without reference to other trials and other results. In a couple of articles published over the last two weeks, my co-authors and I deliver… Continue reading No trial stands alone
When is it legitimate to stop a clinical trial early?
Inspired by a paper that I’m working on with a few of my colleagues from the STREAM research group on the subject of the accrual of subjects in human research, I’ve been reading through a number of articles related to the question, When is it legitimate to stop a clinical trial that is already in progress?… Continue reading When is it legitimate to stop a clinical trial early?
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?
Missing Reports: Research Biopsy in Cancer Trials
A growing number of drug trials are collecting tissue to determine whether the drug hits its molecular target. These studies are called “pharmacodynamics.” And in cancer, many pharmacodynamics studies involve collection of tumor tissue through biopsies. These procedures are painful, and are performed solely to answer scientific questions. That is, they generally have no diagnostic… Continue reading Missing Reports: Research Biopsy in Cancer Trials
Targeted Cancer Drugs: The "Price of Progress"?
So here is the party line on the newest generation of cancer drugs. Unlike older generation drugs, which are generalized poisons, newer cancer drugs hone in on very specific molecular targets. Because of this specificity, they have fewer “off-target” effects, and hence fewer side effects. In the current issue of Journal of Clinical Oncology, Niraula… Continue reading Targeted Cancer Drugs: The "Price of Progress"?
Registration of Trials: A Census
Apologies to the millions of avid followers of Lost in Translation for the long haitus. In response to an international petition campaign, with several Nobelist signatories, I am cautiously restarting this blog with the aim of (monthly??) blogposts on troubles and turmoil in clinical translation. We lead off with an article in this week’s JAMA,… Continue reading Registration of Trials: A Census
Embryonic Stem Cell Trials Start Development
So, FDA has lifted a hold on the first ever clinical trial testing cells derived from human embyonic stem cells. The study- based in California and sponsored by the biotechnology company Geron (view press release here)- will administer cells derived from human embryos (“neural support cells”) to ten patients with recent spinal cord injury with… Continue reading Embryonic Stem Cell Trials Start Development
Ted Kennedy: 1932 – 2009
Ted Kennedy, who died two days ago, championed many of the issues covered in this blog, among them access to health care, funding for research, and a strong drug regulatory system. To those who care deeply about these issues, his indefatigable advocacy will be missed. Among the many landmark laws and regulations that owe their… Continue reading Ted Kennedy: 1932 – 2009