J Altern Complement Med. 2000 Jun; 6(3): 245-51.

Guidelines for clinical research in complementary medicine.

Aldridge D.

Faculty of Medicine, Universität Witten/Herdecke, Germany. davida@uni-wh.de

There are several stages in preparing clinical research studies. Stage 1 includes identifying the purpose of the inquiry and finding the essential financial resources. Careful thinking about the clinical practice to be investigated and the allocation of time for research is also necessary. Stage 2 involves assessing the feasibility of the study. Statistical decisions are best made before data are collected, and this means consultation with a statistician or methodologist. There has to be ethical approval from the cooperating institution. A thorough search of the literature is fundamental. In Stage 3, the final trial is designed, ethical approval obtained, and the proposal is submitted for funding. In the final stage, Stage 4, the trial is carried out, analyzed, and prepared for publication.