Assessment: domains and instruments
Ethical and practical issues in conducting clinical trials in psoriasis and psoriatic arthritis
Dr A Kavanugh
Center for Innovative Therapy, Division of Rheumatology, Allergy, and Immunology, University of California, San Diego, 9500 Gilman Drive, Mail Code 0943, La Jolla, CA 92093-0943, USA; firstname.lastname@example.org
Ethical considerations are inexorably intertwined with the conduct of clinical research. As a result of progress in immunology and biotechnology, several potent novel therapeutics have recently emerged for the treatment of patients with various immunologically driven systemic inflammatory conditions, including psoriasis and psoriatic arthritis. Because of these developments, there is a need to continually assess the design of current and future research studies so that they may be conducted in the optimal and most ethical manner.
Keywords: ethics; psoriatic arthritis; psoriasis; clinical trials
Annals of the Rheumatic Diseases 2005;64:ii46-ii48. © BMJ Publishing Group Ltd & European League Against Rheumatism.
Conduct of clinical research may be the area of medicine most directly linked with ethical considerations. Indeed, many of the milestones in ethical principles have come from deliberations surrounding infamous historical events in clinical research. The intimate association of ethics and clinical research has been well illustrated recently in various autoimmune systemic inflammatory diseases as a result of the introduction of novel, highly effective therapeutic agents. For example, biological agents, in particular inhibitors of the key proinflammatory cytokine—tumour necrosis factor (TNF)—have been shown to be capable of inducing substantial improvements in the signs and symptoms of disease as well as in the quality of life for patients with psoriasis and psoriatic arthritis. The substantial clinical efficacy of these agents has not only spawned further research studies, but it has also raised numerous ethical and practical questions concerning study design in this area, such as:
- Now that these powerful new drugs are available, what are the most appropriate comparators for future studies of other new drugs?
- Under what circumstances, if any, should the use of placebos be permitted?
- What is the responsibility of the sponsor and/or the healthcare payor in continuing to provide expensive therapies to patients after they have participated in clinical studies?
With advancements in basic immunology and in pharmacotherapeutics, ethical concerns have become increasingly complex; it often seems that there are more questions than answers. One approach towards achieving greater insight into these areas is to frame the discussion using several of the core principles of medical ethics. These include patient autonomy, beneficence, non-maleficence, and distributive justice.1