The Changing Clinical Trials Scene: The Role of the IRB

Best hope or last hope: access to phase III clinical trials of HER‐2/neu for advanced stage breast cancer patients

“…1994 , Weijer 1995). Clinical trials for experimental treatments for terminal illnesses are dealing with patients that do not have much time; these patients feel they cannot wait for the outcome to access new therapies ( Mitchell & Steingrub 1988). By decreasing the sample size, and thus slowing trial progress, are we providing ‘good’ in a timely fashion, and in a fashion that outweighs the costs?…”

“…When no effective standard treatment exists, as is often the case with breast cancer patients over‐expressing HER‐2/neu, a trial should have an open treatment arm to allow ineligible patients access to the experimental therapy ( Weijer 1995). As stated by the Investigational Review Board (IRB) ‘…“if a drug is intended to treat a serious or immediate life‐threatening disease, and if there is no comparative or satisfactory alternative drug or other therapy available to treat that stage of the disease in the intended patient population” an investigational drug or therapy may be prescribed…’ ( Mitchell & Steingrub 1988 p. 2). Gail (1985), Vanderpool and Weiss (1987), Byar (1990) and Weijer (1995) have suggested a variety of methods to treat individuals who are ineligible, outside of clinical trials, so that these people can receive the therapies and scientific research will not be compromised.…”

The Institutional Review Board as a mirror of scientific and ethical standards.

“…It was decided that the only scientifically acceptable way to find out whether the Salk treatment really worked was to administer a placebo to a control group of children in such a way that none of the subjects would know whether they had received the therapeutic vaccine or the placebo. This and other features of this pioneering study would become technical standards to consider when the concept of the IRB was realized a decade later (Mitchell & Steingrub, 1988).…”

“…For example, groups have lobbied for quicker release of relevant drugs for dying patients, drug companies have marshaled support for changes in access of research participants to experimental treatments, and researchers who see deficiencies in the medical community's and general public's understanding of the meaning of informed consent have pressed for education of these constituencies (Mitchell & Steingrub, 1988). Such pressures can produce a ripple effect leading to changes in national and regional criteria for the evaluation of research, ultimately affecting IRBs that are obliged to incorporate such standards.…”