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Benefits of Listing Trials in NCI’s PDQ® Cancer Clinical Trials Registry
Submission and Update Process
Features of PDQ Cancer Clinical Trials Registry
NCI’s PDQ® Cancer Clinical Trials Registry is the largest registry of cancer clinical trials in the world. The registry contains trial descriptions for more than 6,000 clinical trial protocols that are open/active and approved for patient accrual (accepting patients), including trials for cancer treatment, genetics, diagnosis, supportive care, screening, and prevention. PDQ also includes behavioral, epidemiologic, health services research, and biomarker and laboratory analysis studies. In addition, the registry contains descriptions for more than 17,000 clinical trials that have been completed or are closed to patient accrual. The PDQ Registry is widely used by patients, health professionals providing cancer care, clinical researchers, and meta-analysts. Trials in the registry are searchable on the NCI Web Site at http://www.cancer.gov/clinicaltrials/search.
Quick Guide to Listing Trials in NCI’s PDQ Cancer Clinical Trials Registry
- Use PDQ’s online submission portal to submit a trial with minimal effort.
- To complete your submission, you will need
- protocol document in Word, WordPerfect, or PDF format
- a copy of the IRB approval in Word or PDF format
- a copy of approval from the scientific review committee, if the trial is at an NCI-designated cancer center.
- If you are submitting a study conducted under an Investigational New Drug application with the Food and Drug Administration, please provide IND information.
- If you are submitting a multi-center study, you will need a list of sites and contact information.
- If electronic copies of some of the documents are not available, you can fax hard copies to 301-480-8105.
- Trial information is accessible to a large international audience of cancer patients, caregivers, family members, and health professionals. The information is available through the NCI Web site and through other clinical trial Web sites, such as the National Library of Medicine’s ClinicalTrials.gov, the National Coalition of Cancer Cooperative Groups’ TrialCheck, and the American Cancer Society’s Clinical Trials Search Service. The PDQ Cancer Clinical Trials Registry is distributed to these services through a licensing program.
- NCI will provide all clinical trial listings to the ClinicalTrials.gov registry.
NCI will also provide investigators with the NCTID, the unique identifier for a trial in the ClinicalTrials.gov registry. This will facilitate the publication of trial results according to the requirements set forth by the International Committee of Medical Journal Editors (ICMJE).
- Investigators and their research teams do not need to write trial descriptions. Trained writers are available to create trial descriptions in a standardized manner. The use of formal guidelines for writing the trial descriptions ensures consistency among trial summaries and makes it easier for users to read about and compare trials.
U.S. and non-European trials
- Use PDQ’s online submission portal to submit a trial with minimal effort. You will need the following:
- Protocol document in Word, WordPerfect, or Portable Document Format (PDF) format.
- A copy of the Institutional Review Board Approval from at least one participating site. If this is not electronically available, you can fax this to 301-480-8105.
- A copy of the approval by a scientific protocol review committee, such as a Protocol Review and Monitoring System at an NCI-designated cancer center. This is used to indicate NCI support for the trial.
- If your trial is a multi-center trial, please include a list of sites and contact information.
- You also have the option of registering (creating a profile) with our submission portal. By registering, you can submit trials in the future, without reentering your contact information each time.
- You can also e-mail all the required information as attachments to PDQSubmission@nci.nih.gov. Please make sure you include the Protocol Number in the Subject Line of your e-mail.
- Most trials are processed and added to NCI’s Web site within two to three weeks from the time of a completed submission.
- New trials and trial updates are added to the Cancer.gov Web site and to ClinicalTrials.gov every weekday (M-F).
Principal Investigators or other designated trial personnel are asked to review the trial description prepared by the PDQ staff as soon as the trial is processed, and then on an annual basis. This allows investigators to verify that the trial description accurately reflects the clinical trial protocol.
- Every three months an e-mail is sent to a designated trial update person with a link to a personalized PDQ Trial Update Web site to verify trial status and site information.
- Trial personnel can send updates, including amendments, at any time to PDQUpdate@cancer.gov. These will be used to update trial descriptions.
The NCI Liaison Office in Brussels, Belgium coordinates registration of European trials in PDQ. Please contact them at firstname.lastname@example.org for more information. The NCI Liaison Office staff can respond to your inquiries in English, French, or German.
- All PDQ trial summaries are available in two versions on www.cancer.gov. The patient version is written in non-technical language and is directed toward a lay audience. The health professional version is written in more technical language and is designed for medical professionals.
- The patient versions of clinical trial summaries are supplemented with links to a non-technical dictionary of medical and scientific terms. This helps patients, caregivers, and their family members understand medical terminology.
- Clinical trial descriptions for patients are presented in the context of other helpful information that describes what clinical trials are and how they help cancer patients.
- Trials in the PDQ Registry can be searched using either the Basic or Advanced Search Form. The basic search form allows users to select a type of cancer, stage/subtype of disease, type of trial, and location of trial (ZIP Code proximity). The advanced search form allows additional search criteria, such as type of treatment/intervention, drug name, phase of trial, and other parameters.
- Trials in the PDQ Registry are coded using a controlled cancer terminology that enhances the accuracy of trial search and retrieval. The controlled terminology is a product of NCI’s Enterprise Vocabulary Services.
If you have any questions or need further assistance, please call the PDQ Protocol Coordinator at (301) 496-7406 or e-mail at PDQSubmission@nci.nih.gov.
If you are not able to use the online submission form or e-mail, you can mail all the information to:
PDQ Protocol Coordinator
Office of Cancer Content Management, OCE, NCI, NIH
6116 Executive Blvd. Suite 3002B MSC-8321
Bethesda, MD 20892-8321
Documents of no more than 20 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.
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