Methodology of Clinical Trials for Tinnitus
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There is no established methodology for clinical trials of tinnitus treatment.
Inter-study comparability is difficult due to insufficient characterization of investigated samples and variation of the used assessment and outcome measures.
Clinical trials in tinnitus should follow standards set by the guidelines of Good Clinical Practice, by the Consort statements, and should be registered in a clinical trial registry.
The design of the clinical trial depends on the clinical question, which should be answered by the study.
Placebo-controlled randomized trials represent the gold standard for testing efficacy of treatment approaches. However, in order to save resources, a stepwise approach seems reasonable, which involves pilot open trials as a first step to screen for potentially promising treatments and which is followed in case of positive outcome by randomized controlled trials.
Due to the heterogeneity of tinnitus, the best possible characterization of the investigated study sample, with respect to clinical or neurobiological characteristics, is highly desirable.
Outcome criteria for therapeutic trials have to be reliable, valid, specific, and relevant.
Trial design should be based on statistical estimation of sample sizes and power in order to minimize the risk of type I and type II errors.
To enhance inter-study comparability, international accepted standards for patient assessment and outcome measurement should be followed.
Standardization of clinical trial methodology will enhance clinical research in tinnitus by facilitating data comparison across trials and allowing pooled data analyses of multicenter study results in international databases.
KeywordsTinnitus Clinical trials Placebo Inter-study comparability
- 1.Friedman, LM, Furberg, CD, DeMets, DL Blindness. 3rd ed. New York: Springer; 1998Google Scholar
- 3.MRC Health Services and Public Health research Board. A framework for development and evaluation of RCTs for complex interventions to improve health. London: MRC; 2006Google Scholar
- 4.Klinkhammer-Schalke, M, Koller, M, Ehret, C, Steinger, B, Ernst, B, Wyatt, JC, et al Implementing a system of quality-of-life diagnosis and therapy for breast cancer patients: results of an exploratory trial as a prerequisite for a subsequent RCT. Br J Cancer, 2008; 99(3):415–22PubMedCrossRefGoogle Scholar
- 5.Klinkhammer-Schalke, M, Koller, M, Wyatt, JC, Steinger, B, Ehret, C, Ernst, B, et al Quality of life diagnosis and therapy as complex intervention for improvement of health in breast cancer patients: delineating the conceptual, methodological, and logistic requirements (modeling). Langenbecks Arch Surg, 2008; 393(1):1–12PubMedCrossRefGoogle Scholar
- 9.Dobie RA Clinical Trials and Drug Therapy In: Snow JB, editor Tinnitus: Theory and Management Hamilton, USA: BC Decker; 2004; 266–77Google Scholar
- 10.Cohen J Statistical Power Analysis for the Behavioral Sciences, 2nd ed. Hillsdale, NJ: Lawrence Erlbaum; 1988Google Scholar
- 14.International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use (ICH) adopts consolidated guideline on good clinical practice in the conduct of clinical trials on medicinal products for human use. Int Dig Health Legis, 1997; 48(2):231–4Google Scholar
- 15.Wei, PBC, Mubiru, S, O′Leary, S Steroids for idiopathic sudden sensorineural hearing loss. Cochrane Database Syst Rev, 2006; 25(1):CD003998Google Scholar