Non-publication of clinical trial results has been recognized as a serious scientific and ethical problem. Underreporting frustrates evaluation of a drug’s utility and safety, and fails to redeem the sacrifice of trial participants. Thus far, policy measures to counteract non-publication have focused on trials of interventions used in practice. However, 9/10 interventions entering clinical testing… Continue reading Accessibility of trial reports for drugs stalling in development: a systematic assessment of registered trials
Tag: clinical trials
Are Trials Necessary?
Today’s New York Times ran a heartbreaking story by Amy Harmon about two cousins who developed melanoma. One was entered into a cancer clinical trial and received the investigational drug PLX4032. The other was ineligible for the trial, and therefore unable to access the experimental drug. Guess which cousin died? The article is one in… Continue reading Are Trials Necessary?
Everything You Always Wanted to Know About Clinical Research in China, But Were Afraid to Ask
After scandals involving tainted toothpaste, poisonous pet food, adulterated milk, contaminated heparin, and counterfeit medicines, and a thriving trade in organs, one shudders to imagine how well human subjects are protected in drug studies performed in China. Apart from an occasional report in the medical literature, there is little easily accessible information about Chinese human… Continue reading Everything You Always Wanted to Know About Clinical Research in China, But Were Afraid to Ask
Help Wanted, Part 2
So, what are some of the intriguing ethical questions of Kolata’s August 2d article? Here is one: when researchers conduct studies and ethics committees review protocols, resource allocation is an important consideration. If, as Kolata alleges, mediocre trials siphon eligible patients away from good trials, then there is a case to be made that IRBs… Continue reading Help Wanted, Part 2
Red Tape: More IRB-bashing
Slow news day, I guess, at the New York Times. In today’s paper, American Enterprise Institute scholar Sally Satel laments that “federal ethics regulations” have become “so stringent and unwieldy that the ethics oversight system often impedes the kind of careful research we should be promoting.” And the paperwork, according to Satel, is driving up… Continue reading Red Tape: More IRB-bashing
Help Wanted- For the War on Cancer
Earlier this week (Aug 2), Gina Kolata of the NYTimes ran a fascinating story about challenges recruiting patients to cancer clinical trials. The story contains interesting facts, credible claims, analysis, and unfortunately, some misleading conjectures. The problem of patient recruitment also invites some hard headed ethical analysis. First the facts. According to the article, one… Continue reading Help Wanted- For the War on Cancer