A Modern Clinical Trial: 7 Years, 1,000 Patients, and Plenty of Questions About Cost

Paul Basken in The Chronicle of Higher Education:

BpIt was my ritual for seven years. Every day, take two sets of pills—one labeled, the other a mystery. Every three months, take three sets of blood-pressure readings, twice a day for a week. Once a year, collect urine for 24 straight hours, lug it everywhere in an ice pack, then get it through airport security for a flight from Washington to Boston. For me and about 1,000 other participants in our medical trial, the payoff for such tedious detail came back last month: The combination of the two common types of blood-pressure drugs being tested didn’t make any significant difference in the progression of our inherited kidney disease. That was disappointing. But it didn’t necessarily mean that the trial was a failure, a waste of the time I spent on it, or a poor use of the $40-million in taxes that paid for it. The trial’s participants got top-notch medical attention for our polycystic kidney disease, and our records will almost certainly help others with PKD, now and in the future.

…All of that logistical structure can mean a huge financial cost. Randomized trials now account for about 20 percent of the $30-billion annual budget of the National Institutes of Health. Private drug companies spend more than $30-billion on them. Yet drug trials fail at a rate of about 90 percent. That level of failure has attracted serious attention now that U.S. medical research has entered a period of tighter budgets, accelerating technological advances, and extensive procedural reassessments. In that light, much about our trial’s design and execution illustrates a system of human experimentation that’s ripe for overhaul.

More here.