Furthermore, ethical concerns and pitfalls regarding the crossover trials that allow patients to switch from control to experimental arms, for receiving investigational drugs remain a serious problem.
69 Currently most investigators regard combination therapy as investigational.
Mainly for economic reasons, there are no consistent epidemiological data that would allow adequate investigational, preventive or even corrective strategies with regard to this problem.
Following public health problems, first with elixir sulfanilamide in 1937 and then with thalidomide in 1962, investigational new drugs have become increasingly regulated.
In the last decade, investigational approaches using clinical samples for fully human antibody production have been performed, but there are still problems with efficiency and accuracy, which should be solved.
Patients with other clinically significant laboratory abnormalities, uncontrolled infection, concurrent severe medical problems unrelated to malignancy that would expose the patient to extreme risk, patients receiving another investigational drug within 30 days prior to study or receiving concurrent hormonal therapy, immunotherapy and those pregnant or lactating were excluded from the study.
Publications since the Bezwoda fraud was published discuss the problem of treatment coverage without evidence of effectiveness and the need to ensure coverage of investigational or experimental therapies in studies only [ 6, 14, 24, 80- 82].
A crucial problem is that the Food and Drug Administration has approved none of the smallpox vaccines for marketing and classifies all of them as investigational.
Pyridostigmine bromide was once an "investigational" drug.
Vice-president, Investigational Material Supply, GlaxoSmithKline.
