Chicago Urban Health Outreach Project ClinicalTrials.gov Tutorial

1
Chicago Urban Health Outreach ProjectClinicalTria
ls.gov Tutorial

• Use the buttons below to navigate.
• Start by clicking the right arrow to advance to
  the next page.

2
Welcome!Tutorial Contents

• A brief history of ClinicalTrials.gov
• The scope of the database its primary audience
• How to perform a search
• What results you can expect to find

3
A Brief History
The ClinicalTrials.gov information resource was
initiated as a result of the Food and Drug
Administration Modernization Act of November
1997. The legislation requires the Department of
Health and Human Services, through the National
Institutes of Health (NIH), to establish a
registry of clinical trials for both federally
and privately funded trials "of experimental
treatments for serious or life-threatening
diseases or conditions. The database was
launched in February 2000 as a service of the NIH
developed by its National Library of Medicine
(NLM), and is freely available on the internet.
4
Target audience
The database is certainly useful for health care
professionals, but it was designed to provide
patients, family members, and members of the
public easy access to information on clinical
trials for a wide range of diseases and
conditions. Note Other clinical trial
registers, such as the one run by the Cochrane
Collaboration, address the information needs of
clinicians and researchers more directly.
However, most of the others are not freely
available.
5
Scope of the Database
ClinicalTrials.gov currently contains
approximately 7,600 clinical studies sponsored by
the National Institutes of Health, other Federal
agencies, and the pharmaceutical industry in over
89,000 locations worldwide. Studies listed in
the database are conducted primarily in the
United States and Canada, but include locations
in about 80 countries. It includes studies which
are recruiting, and some studies which are done
recruiting and are ongoing. Though the
legislative mandate called for a register of
serious or life-threatening diseases , the
register strives to be a comprehensive listing of
clinical trials
6
A Look at the Front Page
Notice its main features Whats New (clinical
trials in the news) Basic Search Focused
Search Browsing Resource Information
7
Basic Searching

• Enter some basic search terms separated by
  commas, like
• City or state of the study (chicago, gary,
  indiana, iowa)
• Diseases and conditions (lupus, diabetes)
• Experimental treatments (diet, insulin, aspirin)
• Types of studies (phase 3, expanded access)

8
Focused Searching
1) Click on each category name to access details
and definitions
2) Enter terms and select criteria to focus your
search
3) Click the Search Button
9
List of Search Results
Usually several studies will match your search
criteria, presented in a list. Each entry
contains the name of the study and a list of
conditions it addresses.
10
List of Search Results 2
By clicking on the Show all trials dialog box,
you can bring into the list studies which have
stopped recruiting patients. You can remove
these studies by clicking on the box again.
11
List of Search Results 3
You can call up greater detail on the study by
clicking on its title,
or you can select any number of studies by
clicking on the dialog box next to its number,
and then clicking the Display Selected Studies
button.
12
Individual Study Information
The record for each individual study looks
something like this, though much more information
is contained than what is shown here
13
Individual Study Information 2

• For each study, you will find
• a summary outlining the purpose
• the recruitment status
• the eligibility criteria for patient
  participation
• location of the trial
• specific contact information
• Other information in the database that may help a
  patient decide whether to enroll in a particular
  trial includes the disease or condition, the
  particular drug or therapy under study, and the
  phase of the trial. ClinicalTrials.gov also links
  to other online health resources that help place
  clinical trials in the context of a patient's
  overall medical care. 

14
What you wont find

• The ability to register for trials patients must
  contact the recruiters themselves, using the
  contact information provided
• Advice for specific medical conditions though
  the details of each study usually provides links
  to useful information in other NLM databases,
  such as MEDLINEplus and PubMed/MEDLINE.

15
How Do I Get There?

• Its easy simply type the address below into
  your web browser, or click on it to be taken
  there right now

http//ClinicalTrials.gov
16
Thats It!

• ClinicalTrials.gov is designed to be simple and
  easy to use, but it is a young database, so
  expect to see enhancements to its features in the
  near future. Please feel free to email any
  questions or comments to Martin Brennan, CUHOP
  Outreach Coordinator, by clicking here.
• Return to the CUHOP Instruction Center
• Return to CUHOP main page
• Go to ClinicalTrials.gov
• Go to PubMed
• Go to MEDLINEplus
• Tutorial designed April 2003 by Martin Brennan
• NLM website content reproduced by permission