Women's Health Research Registry

This study has suspended participant recruitment.
(No more funding)
Sponsor:
Information provided by (Responsible Party):
Noel Bairey Merz, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:
NCT00574314
First received: December 14, 2007
Last updated: August 24, 2012
Last verified: August 2012
  Purpose

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 charge is intended to cover the cost of maintaining the registry now that initial funding has been exhausted.


Condition Intervention
Healthy
Other: No Intervention

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Women's Health Research Registry

Resource links provided by NLM:


Further study details as provided by Cedars-Sinai Medical Center:

Estimated Enrollment: 10000
Study Start Date: July 2004
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Women Other: No Intervention
Participants will be consented.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

All adult English-speaking women

Criteria

Inclusion Criteria:

  • Adult women
  • English speaking

Exclusion Criteria:

  • We do not include children.
  • We do not include non-English speaking subjects at this time.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00574314

Locations
United States, California
Cedars-Sinai Women's Heart Center
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Cedars-Sinai Medical Center
Investigators
Principal Investigator: C. Noel Bairey Merz, MD Cedars-Sinai Medical Center
  More Information

No publications provided

Responsible Party: Noel Bairey Merz, Director, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT00574314     History of Changes
Other Study ID Numbers: IRB# 4269, 4269
Study First Received: December 14, 2007
Last Updated: August 24, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Cedars-Sinai Medical Center:
women
Registry

ClinicalTrials.gov processed this record on July 24, 2014