Clinical trial

Clinical trials are experiments done in clinical research. Such prospective biomedical or behavioral research studies on human participants are designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietary choices, dietary supplements, and medical devices) and known interventions that warrant further study and comparison. Clinical trials generate data on safety and efficacy. They are conducted only after they have received health authority/ethics committee approval in the country where approval of the therapy is sought. These authorities are responsible for vetting the risk/benefit ratio of the trial - their approval does not mean that the therapy is 'safe' or effective, only that the trial may be conducted.

Depending on product type and development stage, investigators initially enroll volunteers and/or patients into small pilot studies, and subsequently conduct progressively larger scale comparative studies. Clinical trials can vary in size and cost, and they can involve a single research center or multiple centers, in one country or in multiple countries. Clinical study design aims to ensure the scientific validity and reproducibility of the results.

Clinical Trials (journal)

Clinical Trials, subtitled as Journal of the Society for Clinical Trials, is a peer-reviewed academic journal covering clinical trials and related subjects in the field of medical research methodology. It is published six times a year by SAGE Publications on behalf of The Society for Clinical Trials (SCT). The journal's main editor is Colin Begg (Memorial Sloan-Kettering Cancer Center).

Abstracting and indexing

Clinical Trials is abstracted and indexed in: Current Contents, MEDLINE, SCOPUS, and the Social Sciences Citation Index. According to the Journal Citation Reports, its 2010 impact factor is 2.356, ranking it 43rd out of 106 journals in the category "Medicine - Research & Experimental".

Scope

The journal focuses on statistical methods for analyzing and designing clinical trials, including methods to handle departures from randomization and quality of life assessment. It covers methods for handling missing data, sample size calculations, the use of economic outcomes, and diagnostic testing methods.