He conseguido un documento de la FDA relativo a los grupos de control en tratamientos clínicos experimentales. Casi al
principio dice:
Purpose of Control Group (1.2)
Control groups have one major purpose: to allow discrimination of
patient outcomes (for example, changes in symptoms, signs, or other morbidity)
caused by the test treatment from outcomes caused by other factors, such as the
natural progression of the disease, observer or patient expectations, or other
treatment. The control group experience tells us what would have happened to
patients if they had not received the test treatment or if they had received a
different treatment known to be effective.
If the course of a disease were uniform in a given patient population,
or predictable from patient characteristics such that outcome could be
predicted reliably for any given subject or group of subjects, results of
treatment could simply be compared with the known outcome without treatment.
For example, one could assume that pain would have persisted for a defined
time, blood pressure would not have changed, depression would have lasted for a
defined time, tumors would have progressed, or the mortality after an acute
infarction would have been the same as previously seen. In unusual cases, the
course of illness is in fact predictable in a defined population and it may be
possible to use a similar group of patients previously studied as a historical
control (see section 1.3.5). In most situations, however, a concurrent control
group is needed because it is not possible to predict outcome with adequate
accuracy or certainty.
Seguiré leyendo mañana.
Entre el domingo y el lunes se
harán los estudios y a partir de ellos se determinará si entro o no el programa
experimental. Por el momento tengo con que entretenerme.
