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Clinical Trials Results:
Exploring the Dissemination Process
National Institutes of Health,
Technology Assessment Workshop
This statement is more than five years old and is provided solely for historical purposes. Due to the cumulative nature of medical research, new knowledge has inevitably accumulated in this subject area in the time since the statement was initially prepared. Thus some of the material is likely to be out of date, and at worst simply wrong. For reliable, current information on this and other health topics, we recommend consulting the National Institutes of Health's MedlinePlus http://www.nlm.nih.gov/medlineplus/.
This statement was originally published as: Healy B., From the National Institutes of Health: Issuing Clinical Alerts. JAMA 1993;269:3096.For making bibilographic reference to the statement in the electronic form displayed here, it is recommended that the following format be used: Clinical trials results: Exploring the dissemination process. NIH Technol Assess Statement Online 1991 Jan 15 [cited year month day]: (8):2.
Issuing Clinical Alerts
The National Institutes of Health (NIH) has set guidelines for alerting physicians and the public about clinical trial findings in cases in which timely and broad dissemination of results could prevent morbidity and mortality. The new guidelines reflect the NIH's legislated responsibility and ethical obligation to issue such clinical alerts.
In January 1991, the NIH's Office of Medical Applications of Research and National Library of Medicine (NLM) convened a panel to discuss the issues involved in expedited dissemination of clinical trial findings. The panel, chaired by Thomas Chalmers, M.D., of the U.S. Department of Veterans Affairs and the Harvard School of Public Health, Cambridge, Massachusetts, included several principal investigators of the clinical trials that were discussed, media representatives, medical journal editors, and NIH clinical trials specialists and communications experts. Based on the experiences of several institutes whose clinical alerts were used as case studies at the workshop ( Science . 1991;251:374-375) and the discussions that took place, the NIH-wide guidelines address the unusual cases in which clinical trials demonstrate that medical care differing from the prevailing practice offers a patient population a clear-cut and time-sensitive benefit. Any lag time between such findings and their dissemination in effect denies patients the option of obtaining the best care, especially when the window of opportunity for benefit is narrow. In order to focus attention on a new finding that could change an existing treatment paradigm, publication in a peer- reviewed journal should be expedited, and accompanied -- or often preceded -- by other efforts at dissemination. At the same time, the guidelines are designed to ensure that any early dissemination does not circumvent the peer-review process or jeopardize subsequent publication in a professional journal.
When To Do a Clinical Alert
The NIH's guidelines vest authority for determining the medical importance and public health urgency of a study's results with the director of the sponsoring NIH institute. While data and safety monitoring committees are key to such evaluations -- and an important assurance for the reliability of study data -- clinical relevance must be determined by the institute director based on input from the investigators and advisory bodies.
Randomized trials are considered the gold standard for the evaluation of new treatments. Nonetheless, the nature of the information that clinical trials generate and the climate into which these findings are released can differ dramatically. In those cases in which a clinical trial is ended early, an assessment has been made that the contrast between the treatment and control arms is so distinct that continuing the trial would be unethical and that the conclusions likely would be the same if the trial were to proceed. Before issuing a clinical alert, study investigators and NIH officials evaluate such issues as the strength of the trial data, how generalizable the results are to a broader population, and the balance between treatment effect in clinical terms and quality of life. Other factors that played a role in past decisions to issue clinical alerts included the availability of the demonstrated treatment, the existence and effectiveness of alternative therapies, the duration of the treatment window, and the potential for harm if a treatment shown to have negative consequences is continued.
Ensuring Journal Publication
Once the decision to issue a clinical alert is made, the institute director first advises the NIH director. The institute director then contacts the journal editor to get agreement on the urgent nature of the information to be disseminated and to secure expedited peer review of the proposed manuscript. When this was done for the handful of clinical alerts to date, journal editors worked with NIH and clinical trial staff to review and publish papers with the greatest speed possible.
When dissemination of clinical trial findings precedes journal publication, the institute director endeavors to obtain the editor's assurance that early release of a summary of findings will not jeopardized the paper's publication. For example, The Journal of the American Medical Association's policy states explicitly: "In situations where there is an immediate public health need for the information, there should be no delay in its release even if this release antedates AMA journal publication" ( JAMA . 1991;265:400). The New England Journal of Medicine has a similar policy for early release of findings of urgent importance ( N Engl J Med . 1991;325:1371-1373). It published the results of the National Heart, Lung, and Blood Institute's Cardiac Arrhythmia Suppression Trial even though the paper was not submitted until after a press conference had announced the trial's findings.
Notifying Physicians and Press
The NIH associate director for communications, the institute director, and the information officer of the sponsoring institute and the NLM coordinate the dissemination and the NLM coordinate the dissemination of the findings to the medical community and the media. The sponsoring institute provides or approves all information for distribution.
The physicians involved in the study are usually notified first, in order that they may attend to their patients. In some cases the NIH may also have to advise the Food and Drug Administration and other Public Health Service agencies, as well as pharmaceutical companies.
The sponsoring institute distributes significant information to the appropriate health care professionals with supporting research data via electronic and other special releases. Whenever possible, this takes place prior to, or concurrent with, announcement to the public media through press releases and press conferences. Efforts are made to target the groups of physicians most directly affected using the most efficient means. This involves notifying professional societies and voluntary organizations, and using the most appropriate options such as on-line network announcements, faxing, and direct mailings. The NLM announces new clinical alerts and places their full texts in the MEDLINE system, where they may be easily retrieved, for example, by Grateful Med, and transmitted via the Internet. In addition, the NLM faxes the clinical alert to 130 medical school libraries and mails it to 3,800 institutional members of the National Network of Libraries of Medicine.
Timely and thorough information on research results should assist physicians in recommending, advising against, or offering treatment. Also, a summary of clinical trial findings with supporting research data can help ensure accurate media coverage, based on an understanding with journal editors and the press that, in prepublication clinical alerts, a trial summary does not represent a peer-reviewed journal article.
About the NIH Technology Assessment Program
NIH Technology Assessment Conferences and Workshops are convened to evaluate available scientific information related to a biomedical technology when topic selection criteria for a Consensus Development Conference are not met. The resultant NIH Technology Assessment Statements are intended to advance understanding of the technology or issue in question and to be useful to health professionals and the public.
Some Technology Assessment Conferences and Workshops adhere to the Consensus Development Conference format because the process is altogether appropriate for evaluating highly controversial, publicized, or politicized issues. Other Conferences and Workshops are organized around unique formats. In this format, NIH Technology Assessment Statements are prepared by a nonadvocate, nonfederal panel of experts, based on: (1) presentations by investigators working in areas relevant to the consensus questions typically during a 1-1/2-day public session; (2) questions and statements from conference attendees during open discussion periods that are part of the public session; and (3) closed deliberations by the panel during the remainder of the second day and morning of the third. This statement is an independent report of the panel and is not a policy statement of the NIH or the Federal Government.
Preparation and distribution of these reports are the responsibility of the Office of Medical Applications of Research, National Institutes of Health, Bldg 31, Room 1B03, Bethesda, MD 20892.