Aickin M.
The phased approach to CAM research.
Program in Integrative Medicine, and Department
of Family & Community Medicine, University of Arizona, Helfgott Research
Institute, National College of Naturopathic Medicine, 4840 N Valley
View Rd, Tucson, AZ 85718. maickin@earthlink.net
Research in several areas of biomedicine have
benefited from categorizing studies according to their positions in
a hierarchy, starting with small exploratory trials and proceeding through
large-scale demonstration projects. Although most CAM/IM studies clearly
belong to an early research phase, they are frequently designed, analyzed,
and presented using the classical model of Phase III medical research
(primarily the randomized clinical trial). The negative consequences
of this practice will be delineated.
Definitions will be offered for appropriate
phases of CAM/IM research, based on the models existing in other areas
of biomedicine, consistent with opinions expressed by a broad, international
collection of CAM/IM researchers. The general aims of the phases in
this schema are:
Phase 0—to discover aspects of an approach
that is little understood, or for which there is essentially no prior
research.
Phase I—to find the practical problems
and determine the fundamental feasibility of research on a particular
approach.
Phase II—to test the solutions to problems
that were uncovered, and to determine whether there is an indication
of effectiveness that would justify further research.
Phase III—to compare the new CAM/IM approach
with another (either CAM or non-CAM) approach, in order to declare when
one is better than the other.
Phase IV—to investigate the magnitude of
the deterioration of effect that happens with implementation outside
a trial context; to estimate cost-effectiveness. Examples of articles
will be presented that illustrate the points of these definitions.
Finally, an initiative will be described that
has recently been taken by the Journal of Alternative and Complementary
Medicine to encourage the conduct and publication of high-quality,
early-phase CAM/IM research.
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