National Institutes Of Health Launches ClinicalTrials.gov Results Database

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National Institutes Of Health Launches ClinicalTrials.gov Results

Database

http://www.medicalnewstoday.com/articles/124327.php

The National Institutes of Health (NIH) announced an expanded

ClinicalTrials.gov database. The database will accept basic results

information, in addition to trial registrations. Due to growing

public interest and a desire for improved access to clinical trial

information and greater transparency in clinical research, Congress

enacted Title VIII of the Food and Drug Administration Amendments Act

of 2007 (FDAAA, Public Law 110-85, section 801). In response to this

new legislative mandate, those responsible for conducting clinical

trials will submit data after the trial is completed. The enhanced

database will provide summary results statistics for a broad range of

trials of drugs, medical devices and biological products that have

been approved by the Food and Drug Administration. Patient-

identifiable information will not be included.

" Providing scientists, physicians, and the public with results

information could go a long way toward improving safety, " said

Director Elias Zerhouni, M.D.

Clinical trials are research studies that test how well new medical

approaches work in people. Each study answers specific scientific

questions and tries to find better ways to prevent, screen for,

diagnose, or treat a disease. Since 2000, ClinicalTrials.gov, the

largest single registry of clinical trials, has provided patients,

families and members of the public with easy access to information

about a trial's purpose, who may participate, locations, and phone

numbers for more details. This Web site currently has information on

nearly 62,000 ongoing and completed trials sponsored by the U.S.

Federal government, pharmaceutical industry, academic, and

international organizations with locations in all 50 States and in

157 countries.

" In time, the results database will be a powerful tool for

researchers and health care consumers alike, and will have untold

benefits for the public health too. " said A.B. Lindberg, M.D.,

Director of the NIH's National Library of Medicine which developed

and administers the new results database.

Results information will be integrated into the clinical trial

records that can be reached at http://clinicaltrials.gov/, and

through its consumer health information service, MedlinePlus, at

http://medlineplus.gov. MedlinePlus has extensive links to

information about 750 diseases and health conditions, much of it from

the NIH Institutes and Centers.

The National Institutes of Health (NIH) -- The Nation's Medical

Research Agency -- includes 27 Institutes and Centers and is a

component of the U.S. Department of Health and Human Services. It is

the primary federal agency for conducting and supporting basic,

clinical and translational medical research, and it investigates the

causes, treatments, and cures for both common and rare diseases. For

more information about NIH and its programs, visit

http://www.nih.gov.

Located in Bethesda, Md., the National Library of Medicine is the

world's largest library of the health sciences. For more information,

visit the Web site at http://www.nlm.nih.gov.

*Title VIII of the Food and Drug Administration Amendments Act of

2007 (FDAAA, Public Law 110-85, section 801) enacted on September 27,

2007, expanded the scope of trials and information required to be

submitted to Clinical Trials.gov and required the submission of

results data. This system builds on the existing ClinicalTrials.gov

Protocol Registration System and allows sponsors and principal

investigators to clinical trials to submit " basic results " summary

data necessary to satisfy statutory requirements. Submission will be

publicly posted on ClinicalTrials.gov