Focus on Alternative and Complementary Therapies
www.pharmpress.com/fact
Focus Alternat Complement Ther©2005 Pharmaceutical Press
Focus Altern Complement Ther 2005; 10: 03–4
RCTs have been developed for phase III studies with a drug or drug-like intervention. They are seldom appropriate for earlier phase studies, which includes most CAM research at present. The purpose of this project was to find, categorise, and explicate early-phase designs that offer a competent alternative to RCTs.
Literature was reviewed in biomedicine, epidemiology, biostatistics, artificial intelligence, psychology and a few related disciplines in order to find designs that have been proposed for early-phase research.
A number of key decisions need to be made in selecting a design: qualitative vs. (or in addition to) quantitative measures; control group vs. none; randomised vs. balanced; observational vs. interventional; intensive vs. superficial measures; hypothesis testing vs. something else; reductionist vs. whole-systems; conventional vs. novel. A number of innovative designs were discovered, including participant-centred analysis with intensive measurements, various versions of crossover designs without control groups, observational studies with cross-checks and bounds on residual confounding, analyses based on causal theory using special features of the research setting and alternatives to expensive, conventional statistical inference criteria.
It is possible to structure the selection of a design into a decision-tree format in which the researcher can use their expertise in the science, clinical characteristics and measurement opportunities to select a strong design for an early-phase CAM study.
This project was made possible by support from the Program in Integrative Medicine, University of Arizona.
