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NCT00574314 · ClinicalTrials.gov registry record
Women's Health Research Registry
A clinical trial, sponsored by Cedars-Sinai Medical Center.
- Terminated
- Registry status
- 839
- Enrollment target
NCT00574314 is a clinical trial that was terminated before completion, run by Cedars-Sinai Medical Center. The registered enrollment target is 839 participants.
The verdict
NCT00574314 was terminated before completion, sponsored by Cedars-Sinai Medical Center.
- TERMINATED
- Registry status
- 839 participants
- Enrollment target
Study Summary
Women have been disproportionately underrepresented in clinical research. Few of the many drugs approved by the FDA have been adequately tested in women. Most common health conditions experienced by both women and men are managed by treatments that have been developed and tested most in men. A new barrier to enrolling women in clinical trials is in effect: HIPAA (the Health Insurance Portability and Accountability Act). The positive benefit of HIPAA-protecting a person's health information from abuse-is laudable, but it comes at a cost: it will deny investigators the benefit of access to chart (medical record) review in order to gather data to answer clinical questions. In the past, investigators were allowed access to patient's charts because the hospital consent form included a clause indicating that the patient's information may be used for research. The investigators propose to overcome this crisis and challenge with a proven method of identifying individuals who would be willing to consider participating in a clinical trial: The Women's Guild Health Research Registry. In keeping with the focus of the Women's Health Program, we would propose to enroll only women. The registry will allow qualified investigators to identify potential study participants. This idea has been effective at improving the quantity and quality of women able and willing to participate in trials. The investigators will also allow other approved sites to utilize the Registry via the approved procedure of submitting an IRB approved protocol which will be reviewed by our Internal Review Committee. This protocol's inclusion/exclusion criteria will be used to query the database for eligible participants. The participants will be contacted by the Registry staff to ascertain their interest in this research protocol and their agreement to release their contact data to the investigator will be obtained. Investigators will be charged at the time they approach the registry for assistance. The char
Interventions
- OTHER No Intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 839 participants |
| Start Date | 2004-07 |
| Est. Completion | 2012-11 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00574314
The ClinicalTrials.gov registry entry for NCT00574314 describes a study currently listed as terminated, categorized as an unspecified phase. The registered enrollment target is 839 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cedars-Sinai Medical Center, which has 339 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which No Intervention is the first listed.
NCT00574314 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00574314 about?
NCT00574314 is a clinical study titled "Women's Health Research Registry". Women have been disproportionately underrepresented in clinical research. Few of the many drugs approved by the FDA have been adequately tested in women. Most common health conditions experienced by both women and men are managed by treatments that have been developed and tested most in men. A new ...
What is the current status of trial NCT00574314?
This trial is currently terminated. The enrollment target is 839 participants. The study started on 2004-07. Estimated completion is 2012-11.
What interventions are being tested in trial NCT00574314?
The interventions under investigation include: No Intervention (OTHER).
Who is sponsoring clinical trial NCT00574314?
This trial is sponsored by Cedars-Sinai Medical Center, which has 339 total clinical trials registered on ClinicalTrials.gov.
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