Sociological and Ethical Aspects of Clinical Trials - From the Nuremberg Code to ICH-GCP Guidelines and Beyond
Institute of Sociology and Social Policy Corvinus University of Budapest Budapest, Hungary
My purpose is to lay down the basics of interpreting and analyzing the rapidly growing phenomena of clinical trials. In my interpretation the spread of clinical trials is the fulfillment of empirism in medicine. Patients are treated in a standardized way according to the protocol of the trial. The results of tests on individual patients are connected in one single database. Only by this it is possible to detect rare adverse events (lack of adverse events=safety) and to evaluate efficacy (efficacy= heals the illness) of the investigational medical product (IMP). Pharmas are constantly controlling each other by double-blind, randomized, active- and placebo-controlled trials in which they compare their own IMP with a registered medication of another pharma and with placebo. Mandatory reporting to competent authority ensures that a product inferior to placebo or of bad safety profile cannot stay on the market.
Just a foretaste of the wide range of ethical considerations: It is not proven empirically yet that the IMP is safe and effective. To find out, the IMP has to be tested on many patients ? who all seek treatment when turning to the physician. This brings us to the issue of ?therapeutic misconception? of patients, the validity of the Patient Informed Consent, patients? trust in their physicians, the ?recruiting doublespeak? and the (financial) conflict of interests of investigators. Being randomized to the placebo arm per se means not receiving treatment. Randomization and blindness means that the physician does not know what substance his/her patient is getting. Early phase trials often do not have any therapeutic intention. Clinical research on special populations like people with cognitive impairments, children, captive populations needs special attention. Trials in emergency situations (e.g.: stroke, heart attack) cannot be conducted with prior consent of patients. Shall they be conducted at all?
On the other hand, access to clinical trials (once exclusively conducted on vulnerable populations) became a privilege, especially for patients suffering from incurable diseases. The current exclusionary practice toward women and racial minorities will result in medications biased towards white males, the dominant group in the society and in the clinical research.