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1. What is PDQ?
2. What information about
clinical trials is in PDQ?
3. How
does an investigator submit a clinical trial to PDQ?
4. Is there a checklist of information
that I need to submit?
5. Can I submit just a summary
of my clinical trial or do I
need to submit the entire protocol document?
6. Can I submit supportive care clinical
trials to PDQ?
7. How long does it take to list
a clinical trial in PDQ?
8. How do I know if my clinical trial protocol will
require further review?
9.
Can I list one telephone number for all inquiries instead of listing each PI
and their contact number?
10.
Do I need to submit IRB approval from all the participating sites?
11.
Do I need to get IRB approval for the clinical trial abstract that will be listed
in PDQ?
12.
How often is the information about the clinical trials updated?
13.
How do I make changes to my clinical trial abstract once it is in PDQ?
14.
How do I add additional participating sites to my clinical trial abstract?
15.
How long does it take for clinical trial abstract changes to show in PDQ?
16.
How do others obtain clinical trial information from PDQ?
17.
How much does it cost to list my clinical trial in PDQ?
18.
Who do I call if I have further questions about submitting clinical trial protocols
to NCI?
1. What is PDQ?
PDQ (Physician Data Query) is an online database that contains cancer information summaries, listings of
clinical trials, and directories of physicians and organizations (directories not yet available online) involved in cancer care. PDQ was developed
and is maintained by the Cancer Information Products and Systems program of the U.S. National Cancer Institute (NCI)
with the help of cancer experts from across the U.S. PDQ has been in existence since 1984 and is available
worldwide. It is used by health professionals and patients to find the latest information about cancer.
PDQ is available on the NCI's Cancer.gov website.
2. What information about
clinical trials is in PDQ?
PDQ provides abstracts of ongoing treatment, screening, prevention, genetic, diagnostic and
supportive care clinical trials.
The abstract includes the study title, objectives, and detailed eligibility criteria. Each clinical trial abstract is indexed for the type of cancer (including disease stage, if specified in the protocol),
the interventions and drugs being used, and the study phase. As a result, clinical trials can be retrieved by any or all of these criteria. For trials actively
accruing participants, the abstracts are augmented with a listing of organizations in which the trial is taking place and their principal investigators.
Clinical trials in PDQ are also searchable by state/province, city, postal code, or country, based on this list of participating organizations.
3. How does an investigator submit a clinical trial to PDQ?
There are several ways to submit clinical trials, depending on the level of
prior review and the source of the study. Please refer to the PDQ
Quick Reference Guide for a more detailed description.
4. Is there a checklist of information that I need to submit?
Yes, there is a protocol
submission checklist. This checklist provides the necessary items to
complete your protocol submission.
5. Can I submit just a summary
of my clinical trial or do I need to submit the entire protocol document?
If your trial does not need additional review (please see PDQ
Quick Reference Guide) you may use our online
protocol submission form or submit a summary that includes all the fields
listed on the online form.
6. Can I submit supportive care clinical
trials to PDQ?
Yes, you may submit supportive care studies. PDQ has treatment, prevention,
screening, genetic, diagnostic, and supportive care studies.
7. How long does it take to list a clinical trial in PDQ?
Studies are usually listed within 6 weeks of their submission. If the study must be
reviewed by the PDQ Protocol Review Board, it may take additional time to list the study.
8. How do I know if my clinical trial protocol will
require further review?
The PDQ Quick Reference Guide
gives an overview of which trials may need further review and the process for
submission.
9.
Can I list one telephone number for all inquiries instead of listing each PI and
their contact number?
Yes. Please provide us with the telephone number
and let us know that you prefer to use this number instead of listing each participating site. However,
we prefer to have the full list of participating sites because our users often narrow their clinical trial searches geographically.
If we do not have a complete list of participating sites, your clinical trial will not be retrieved geographically.
10.
Do I need to submit IRB approval from all the participating sites?
We do expect all the sites to have IRB approval, but we only need a copy of the IRB approval from one of the sites.
11.
Do I need to get IRB approval for the clinical trial abstract that will be listed in
PDQ?
No. According to the FDA guidelines for IRBs and Clinical Investigators, listing your clinical trial abstract in PDQ is not considered advertisement and does not need approval from an
IRB.
12.
How often is the information about the clinical trials updated?
PDQ is updated every month.
NCI staff send requests quarterly to the designated update person to verify the status of active and approved trials.
Requests verifying participating sites and contacts are sent quarterly.
The abstract of the clinical trial is sent to the protocol chairperson at least annually for review.
13.
How do I make changes to my clinical trial abstract once it is in PDQ?
Changes to the abstract may be sent to us at anytime. You may send your changes by mail, fax, or e-mail. You will also receive mailers
from us to review your protocol information.
14.
How do I add additional participating sites to my clinical trial abstract in PDQ?
You may add additional sites to your clinical trial abstract by sending us the information
by fax, e-mail, or mail. Please include the Principal Investigator's name, institution name, address, and telephone number.
15.
How long does it take for clinical trial abstract changes to show in PDQ?
Clinical trial abstract changes and changes to the sites and trial contacts will be visible in PDQ for the next monthly update. Clinical trials status changes will be visible in PDQ within 10 days of receipt of a mailer or notification by email or telephone of a status change. When requested, emergency updates can be made to correct or remove erroneous information.
16.
How do others obtain clinical trial information from PDQ?
There are a number of ways that people may obtain information from PDQ.
Health care
professionals and cancer patients, their families, and the public can obtain clinical
trial information by calling the NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237); TYY: 1-800-322-8615.
Some hospitals, university libraries, and large public libraries have PDQ access.
People
can also access clinical trial information by visiting Cancer.gov.
17.
How much does it cost to list my clinical trial in PDQ?
PDQ is a federally sponsored database.
There is no cost to list your trial in PDQ.
18.
Who do I call if I have further questions about submitting clinical trial protocols
to NCI?
If you have further questions, please call the
PDQ protocol coordinator at 301-496-7406 or email at protsub@cips.nci.nih.gov.
Additional Information
If sending hard copy documents, send to:
PDQ Protocol Coordinator
Attn: CIAT
Cancer Information Products and Systems, NCI, NIH
6116 Executive Blvd. Suite 3002B MSC-8321
Bethesda, MD 20892-8321
Documents of no more than 10 pages (e.g., the IRB approval) may be faxed to
the PDQ Protocol Coordinator at: 301-480-8105
PLEASE clearly identify the protocol by number when faxing related materials.
Protocol documents and other related materials may be sent as a Word or
WordPerfect file via electronic mail to: protsub@cips.nci.nih.gov
PLEASE include the protocol number in the subject line of the message when
sending materials by electronic mail.
QUESTIONS? Call the PDQ Protocol Coordinator at 301-496-7406
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