title: Randomized clinical trials: is periodontal research good for patients?
abstract: Randomized controlled trials, in which randomization is used to allocate patients to a treatment arm, are a relatively new concept. Randomized controlled trials are increasingly high-stakes endeavors requiring a high level of planning and considerable financial support. Randomized controlled trials are the gold standard by which effectiveness of various treatments or interventions are determined. However, the methods involved in randomized controlled trials raise the question: is clinical research good for the participants? This paper discusses patient-centered issues relating to randomized controlled trials, for example, whether the informed-consent process results in subjects who are knowledgeable and informed about their participation, which, in turn, involves patient autonomy, health literacy and treatment preferences. Other issues discussed are those of statistical vs. clinical significance, professional ethics and ethical justification for randomized controlled trials, and differences in perceptions between patients and clinicians regarding the level of care being provided by the randomized controlled trials. Because our goal, as clinicians, is to provide treatment that improves the quality of life for the patient, it would seem logical that randomized controlled trials should include variables rated as important by patients as valid outcome measures. As clinicians and researchers, we can no longer afford to view randomized controlled trials from an ivory tower. Research participants, although autonomous agents, are inherently different from the patient seeking clinical care. Researchers have an ethical responsibility to consider the informed consent process as it relates to the subject's health literacy and potential for therapeutic and procedural misperceptions.
authors.forename: Karen B
authors.initials: KB
authors.lastname: Williams
authors.forename: Alan
authors.initials: A
authors.lastname: Glaros
authors.forename: Mary P
authors.initials: MP
authors.lastname: Walker
authors.forename: Charles M
authors.initials: CM
authors.lastname: Cobb
mesh_terms: D018865:Dental Research / Q000592:standards; D032984:Ethics, Research; D057220:Health Literacy; D006801:Humans; D007258:Informed Consent; D057240:Patient Preference; D010510:Periodontal Diseases / Q000628:therapy*; D026684:Personal Autonomy; D016032:Randomized Controlled Trials as Topic / Q000592:standards; D012107:Research Design