'clinical trials' posts

On March 27, the U.S. Food and Drug Administration approved the newest treatment in the increasing number of disease modifying therapies (DMTs) available to treat multiple sclerosis. Tecfidera (BG-12) is an oral capsule to treat adults with relapsing forms of MS. Research participants at the MS Center at Swedish participated in clinical trials for Tecfidera.

The trials reported that people taking Tecfidera had fewer relapses and less frequent worsening of disability compared to people taking a placebo. There were also fewer and less-severe side effects with Tecfidera than other treatments.

The studies found that ...

Medicine does not search for truth. It searches for cure. It does not look for the universal, it tries to create exceptions.

Medicine emerged from witchcraft. It has always utilized the most advanced technology of its day. Medical models and reasoning always evolve and that evolution makes the previous model obsolete. One of the foundation models of modern medicine is the randomized controlled clinical trial.

The principal of the randomized controlled clinical trial is that a single observation needs to be validated and reproduced. The clinical trial provides an estimate of how often a particular observation will occur. It tells us that chemotherapy improves survival for patients with non-small cell lung cancer at one year from 20% to 29%. It tells us that FOLFOX treatment for advanced colon cancer gives a median time to progression of 8.7 months, response rate of 45%, and median survival time of 19.5 Months. This is accurate information about populations. It's use for the individual is a difficult problem.

Every person is a unit, no one is 20% or 29% or 45%. The question is...