Arthritis & Rheumatology
© American College of Rheumatology
Edited By: Richard J. Bucala, MD, PhD
Online ISSN: 2326-5205
Associated Title(s): Arthritis Care & Research
Clinical Trials Policy
- As of January 1, 2007, all prospective, interventional studies (be they initiated before or after that date [but not including trials that were completed before that date]) must be registered at either www.clinicaltrials.gov or www.controlled-trials.com in order to be considered for publication in either Arthritis & Rheumatology or Arthritis Care & Research. Phase I clinical trials, pharmacokinetic studies, and those that do not involve a concurrent control group are excluded from this policy at the present time.
- For studies initiated after January 1, 2007, registration must occur before the first patient is enrolled.
- In addition to prospective studies of drugs, biologic agents, and devices, this requirement will include prospective investigations of prevention strategies, screening procedures, diagnostic algorithms, health promotion approaches, behavioral interventions, and health care economics.
- Retrospective reviews, studies designed only to generate pharmacokinetic data, and observational studies that do not involve interventions are not included in this policy.
- The list of suitable Web sites will be updated from time to time, as new options emerge.
- We anticipate that some manuscripts will not be easy to classify and will raise questions about whether the new policy does or does not apply. In such cases, subcommittees of either the editorial boards of the journals or the ACR Committee on Journal Publications will review and adjudicate the status of the manuscript in question.
Further details on the journals’ clinical trials registration policy can be found in an editorial published in August 2005 in both journals ( Arthritis & Rheumatism