Ein wichtiger Hinweis für alle Leiter von klinischen Studien
Wer zukünftig die Ergebnisse von prospektiven, interventionellen klinischen Studien zu Arzneimitteln und Medizinprodukten o.ä. in Arthritis & Rheumatism bzw. in Arthritis Care & Research publizieren will, muß die Studie registrieren. Stichtag ist der 1. Januar 2007, unabhängig davon, ob die Studie vorher begonnen hat.
Hier der Originaltext bzw. die E-Mail, die wir von den Herausgebern von Arthritis & Rheumatism erhalten haben:
REMINDER TO SUBMITTERS TO ARTHRITIS & RHEUMATISM/ARTHRITIS CARE & RESEARCH, REGARDING REGISTRATION OF CLINICAL TRIALS
In August 2005, an editorial was published in both journals, announcing new policies regarding publication of reports of clinical trials. Specifically, these trials must be registered, in order to be considered for publication. The policy goes into effect January 1, 2007. Details are outlined below:
As of January 1, 2007, all prospective, interventional studies (be they initiated before or after that date) must be registered at either http://www.clinicaltrials.gov/ or http://www.controlled-trials.com/ in order to be considered for publication in either Arthritis & Rheumatism 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.
It is anticipated 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 American College of Rheumatology Committee on Journal Publications will review and adjudicate the status of the manuscript in question.
Michael D. Lockshin, M.D., MACR Editor in Chief Arthritis & Rheumatism.
Edward H. Yelin, Ph.D. Co-Editor-in-Chief Arthritis Care & Research
Patricia P. Katz, Ph.D. Co-Editor-in-Chief Arthritis Care & Research