or procedures governing the clinical trials process need to be changed, and what burdens or costs such changes might place on future clinical trials.
Clinical trials are of vital importance in the development of new drugs for use in humans. Preliminary animal experimentation is important in identifying potentially effective interventions in animal models with simulated human diseases and in identifying efficacious and non-toxic amounts of a pharmaceutical to be given. However, no amount of animal testing can substitute for carefully planned and carefully conducted human studies. The process is a lengthy one (4-7 years) and one which involves many study subjects.
One of the things that sets clinical trials apart from other scientific experiments is the obligation for care. Investigators undertaking them have obligations to ensure that patients enrolled are adequately cared for, even if doing so conflicts with or is at odds with required data collection and treatment procedures, as set forth in the protocol for the trial.
Evaluation of the treatment is relatively straight forward in randomized controlled trials involving comparison of one or more test treatments vs a control treatment (a placebo, standard medical treatment, or another test treatment). Judging the safety or efficacy of a treatment is much more problematic in the case of trials not involving a designed comparison group often the case in early evaluations of a new drug. In those settings, one is often left in a quandary as to what to make of isolated cases of morbidity indicated by observed clinical events or intimated by changes in specified laboratory tests. Are the changes due to the disease itself or to the drug?
Ethical justification of research involving human subjects requires responsiveness to ethical norms or rules that are embodied in six general behavior-prescribing statements: there should be 1) good research design, 2) competent investigators, 3) a favorable balance of harms and benefits, 4) informed consent, 5) equitable selection of subjects, and 6) in some ethical codes but not in US federal regulations, compensation for research-induced injury. In addition to these six substantive norms there are various procedural rules designed to ensure responsiveness to the substantive rules. Most important for the present considerations are: there should be 1) review and approval by an institutional review board and 2) written documentation of informed consent.
Viruses, composed of DNA or RNA inside a protein shell or ''envelope'', include the influenza virus that causes the common "flu," the human immunodeficiency virus (HIV) responsible for AIDS, and the hepatitis B virus (HBV) resulting in a hepatitis infection with variable symptoms. With acute HBV infection patients are frequently fatigued, jaundiced, and complain of abdominal pain. The vast majority of 300,000 persons infected with HBV each year in the U.S. recover completely and only about five percent of infected adults develop chronic liver disease. Although such disease often results in only minor complaints of fatigue,