Whereas empirical methods are obviously powerful in the pursuit of natural science explanations, the complexity of situations and relationships involving human understanding demand an approach that reductionist methods such as controlled clinical trials
cannot support on their own.
In 1996, when the sacred cows of controlled clinical trials
were regarded as unassailable, I was Editor of CME.
In 1981, MS specialists formally agreed that double-blind, controlled clinical trials are the "gold standard" measurement of the effectiveness of therapies for MS.
Without controlled clinical trials, physicians treated MS with the "theory of the day" electricity in the 1860's, psychiatry in the 1930's, drugs to increase blood flow in the early 1950's.
Young said he expects more monoclonal antibodies will be approved following controlled clinical trials
Initial results with dichloracetate look promising, he says, but the larger controlled clinical trials
that weren't done with sodium bicarbonate are needed for the new drug.
Gynex plans to submit New Drug Applications (NDAs) to the FDA for these indications beginning in 1993, as controlled clinical trials are completed.
The FDA Treatment IND is a special procedure designed to provide access to potential new drugs for serious conditions prior to the completion of controlled clinical trials.
Insulin pills, still awaiting controlled clinical trials
, remain a long way off, Ziv notes.
However, it is also acknowledged that only a small portion of medical care has undergone formal evaluation through controlled clinical trials
, such that the true clinical impact of many widely accepted therapies is unknown.
The logic that permits controlled clinical trials
of pharmacologic agents that may directly benefit human health does not pertain here.
The researchers emphasize that this regimen is not ready for use outside of controlled clinical trials