Ethics Roundtable: Ethical Issues in Randomized Clinical Trials
Response by Jeri Logemann
Jeri Logemann, Ph.D.
Communication Sciences and Disorders Clinical Trials Research Group (CSDRG)
Clinical trials or randomized studies of treatment are considered by some professions such as epidemiology and statistics, as well as by some third party payers, as the gold standard in treatment efficacy research because they clearly and carefully define and control as many variables as possible in the treatment process. However, because they are so well controlled, some clinicians criticize clinical trials as not being representative of the real world.
Randomized clinical trials should be able to demonstrate which is the best treatment of the treatments being studied. In the case of this example, three different types of treatments are provided on a randomized basis to each patient. For clinicians to enter patients ethically on to such a protocol they should believe that any one of the three treatments could be efficacious for the patient. Studies that have examined individual versus group therapy versus family education for patients with aphasia have not been able to define clearly the best treatment, therefore there is good rationale for such a comparative study. Random assignment of treatments will balance the therapy groups on age, type, and severity of stroke as well as other specified factors. Patients will receive more regular evaluation in this study through a one year post-stroke period than they would receive in the current insurance payment system, so patients would be followed more carefully in the protocol than they might be in the "real world." Also, patients may receive more therapy in the protocol than they would under current Medicare or other thrid party payment guidelines. The consent to enter the protocol would carefully define all the advantages and disadvantages as well as potential risks to the patient. This protocol does not appear to have any specific risks other than the patient possibly not receiving the best treatment for them, though this has not necessarily been proven in previous research. No potential conflict should be present for the speech-language pathologist who evaluates and enrolls patients, if the speech-language pathologist feels all three treatment arms might be equally advantageous for the patient. There is a great deal unspecified in this brief protocol outline, including the exact nature of the therapy and the primary and secondary outcome measures, all of which would be carefully defined before the protocol was activated.
Clinical trials in Communication Sciences and Disorders offer us the opportunity to define the effectiveness of our interventions and can provide clinicians with an opportunity to participate in research.
Clinical Forum on Treatment Outcomes and Efficacy (1998). Language Speech and Hearing Services in the Schools. 29:243-273.
Facilitating Support for Language Reesearch and Practice (1998). Topics in Language Disorders. 19(1).
To submit cases or to be added to the list of respondents please contact: Helen Sharp Department of Speech Pathology and Audiology, 307 WJSHC University of Iowa, Iowa City, IA 52242. Phone: 319-335-6596, fax 319-335-8851, e-mail: [email protected]