Field testing as clinical trial methodology in periodontics.
In the early 1950s the randomized control trial (RCT) was introduced and became widely accepted as the definitive proof of efficacy of a specific medical treatment. In fact, the acceptance and application of this methodology were instrumental in converting medicine from an unpredictable art to a science. At present no other methodologies exist that allow the evaluation of therapeutic efficacy with confidence comparable to that achieved with randomized controlled trials. In recent years researchers have applied new experimental designs and data analysis techniques to clinical trials conducted in a field trial environment to facilitate the understanding of proper use of new therapeutic agents and procedures. Since many of the new methodologies are still evolving or have only recently been introduced, this review considers some of the major trends and developments, as well as experiences of the authors, in field trial methodology. This manuscript addresses the following questions: 1) are there current clinical trial needs that are not met by RCT? 2) If so, what considerations are necessary for new approaches to have scientific usefulness? and 3) What are the strengths and weaknesses of the field trial's setting relative to an institutional environment?
Kornman
K S
KS
Department of Periodontics, University of Texas Health Science Center at San Antonio.
Newman
M G
MG
Holtzman
S
S
Matheson
J E
JE
D015982:Bias; D002986:Clinical Trials as Topic / Q000379:methods*; D006801:Humans; D010043:Outcome and Process Assessment, Health Care; D010510:Periodontal Diseases / Q000175:diagnosis / Q000628:therapy*; D011358:Product Surveillance, Postmarketing; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012107:Research Design; D012494:Sampling Studies