Clinical trials database can lead to local angle

Investigative Reporters and Editors, Inc. The IRE Journal, Sep/Oct 2002 by Edds, Carolyn

FEATURES

Finding local experts or developing story ideas on medical topics can be a little easier with a search of the clinical trials database at ClinicalTrials.gov, a Web site maintained by the National Institutes of Health and developed by the National Library of Medicine.

The purpose of this Web site, which began in early 2000, is to provide information about clinical trials for drugs used to treat serious or life-threatening diseases or conditions. The trials in this database may receive money from private or federal funds. The Food and Drug Administration Modernization Act of 1997 required the creation of such a database, which has more than 6,300 clinical studies. While most of these are located in the United States or Canada, studies from about 70 countries are included.

The database is searchable in many ways. A "focused search" allows more than one field to be combined in a search. Searchable fields include disease or condition, experimental treatment, trial location, choice of three age groups, or supporting organization type. After the search results are displayed, if desired, click on the box in the upper left corner to include all trials in the search results, both that are, and are not, recruiting patients.

Use this "focused search" to locate local experts on a particular disease. For example, type "lung cancer" in the box labeled "Disease or Condition" and "Portland, Maine" in the box labeled "Trial Location" to find a contact for a clinical trial on that subject in that area. The "focused search" also can find current local clinical trials. In the box labeled "Trial Location," type the name of a local medical facility or the name of a city and state to find trials at that facility or in the area.

While searches by location are allowed, as the trials from those search results are displayed, all of the locations of that trial are listed, not solely the location searched. Some trials may be in progress in many states. This can increase the length of the display, so using the "Find on this page" option from the Web browser menu allows for quicker movement to the desired location. Also, if the name of the city searched might be a city in another state or country, include the entire name of the desired state in the search.

Synonyms for medical terms are included in a search. A search for the phrase "chickenpox" will also include a search for the phrase "varicella." This is helpful since many terms might be used for a similar subject. To view the synonyms added to a search, click on the "Query Details" button in the upper right corner of the search results page.

After a trial is selected, some of the information displayed includes the purpose of the trial, condition, treatment and phase, trial sponsor, MEDLINEplus links to related topics, study type, objectives, eligibility requirements, trial location and contact information, the date the trial started and the last date the trial information was updated.

Boolean operators AND, OR and NOT can be used with the search. Exact phrases can be enclosed in quotation marks. See the "Help" section for more searching tips.

Trials also can be browsed by disease either alphabetically or by disease heading. For example, chickenpox also can be found under the "viral diseases" heading. As with the "focused search," click on the box in the upper left corner to add trials no longer recruiting patients to the search results.

In addition, trials can be browsed by sponsor. The four sponsor types: National Institutes of Health, other federal agency, industry, university/organization. Once a sponsor type is selected, a list of sponsors in that category is displayed alphabetically. Again, to include trials not currently recruiting patients, click on the box in the upper left corner. Unfortunately, it seems that search results cannot be limited to those trials that have been completed.

The Web site includes a section on clinical trials with information such as what a clinical trial is, who can participate in one, the different phases of a clinical trial and a glossary of clinical trial terms.

On a final note, you may also want to consider Center for Drug Evaluation and Research

-Guidance for Industry Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions at www.fda.gov/cder/ guidance/4856fnl.htm.

BY CAROLYN EDDS

Carolyn Edds is the Eugene S. Pulliam research director for IRE. She directs the IRE Resource Center and helps maintain Web resources.