From The College October 2005

The complete newsletter is available in PDF format, below.

Featured Article

New Journal Policy Regarding Registration of Clinical Trials

Human subjects who agree to participate in clinical trials often do so with the idea that they are helping to contribute to medical knowledge.

However, the results of many studies, particularly those with negative findings, are never published or the trials are canceled and, therefore, the findings are not available to the medical community or the general public. This situation, along with recent adverse events with selective serotonin release inhibitors in childhood depression and with COX-2 inhibitors, has fueled a movement toward compulsory clinical trials registration.

Many members of the biomedical research community agree that it is necessary to implement this policy to ensure that physicians have all the information possible regarding the drugs they are prescribing and consumers can understand the risks and benefits of the drugs they are taking. Several organizations, including the ACR, are initiating policies related to registration of clinical trials.

Members of the International Committee of Medical Journal Editors, a committee of editors of 11 general medical journals, have declared that, as of July 1, 2005, they will accept for publication only those reports of clinical trials that have been pre-registered with one of several publicly accessible, free-of-charge Web sites before enrollment of the first patient. The ICMJE statement pertains to prospective interventions of all kinds that involve human subjects, with the exception of phase I trials, pharmacokinetic studies, and studies without concurrent control groups. Members of the Cochrane Collaboration have developed a similar statement. Clinical trials registration is also the topic of bipartisan-sponsored legislation, called the Fair Access to Clinical Trials Act, currently under debate on Capitol Hill.

At its May 2005 meeting, the ACR Board of Directors endorsed the concept that clinical trials registration is in the best interest of patients, clinicians, investigators, and other parties involved in biomedical research, and consequently, a policy similar to the one proposed by the ICMJE is being implemented for Arthritis & Rheumatism and Arthritis Care & Research. Specific details of the policy are as follows:

· As of January 1, 2007, all prospective, interventional studies (be they initiated before or after 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 & 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 for registration of clinical trials will be updated from time to time, as new options emerge.

Proponents of clinical trials registration argue that the conduct of human research without assurance that descriptions of the study and its findings will be available to the public is unethical. They note that clinical
trials registration will lead to a reduction in the potential for patient harm that may arise from unnecessary exposure to interventions that have already been tested by others, deterrence of negative reporting bias, and improvement in the quality of clinical investigation.

Concerns have been raised within the medical community that compulsory clinical trials registration might be onerous to investigators; however, complying with the compulsory registration policies that have been proposed should not take more than a few minutes, and the information can simply be cut and pasted into an Internet-based registry.

More detailed information about the compulsory clinical trials registration movement and the new journal policy is available in the August issue of both Arthritis & Rheumatism and Arthritis Care & Research.