What information is collected by the Registry?
The Registry collects information from the patient at enrollment and confirms it
with the health care provider. Follow-up information is requested from the obstetrical
provider at the end of the second trimester and the end of the pregnancy. Additional
information is requested from the pediatric provider at birth, 4 months, and 12
months. The patient is also contacted for breast-feeding information at 3, 6, 9,
and 12 months after birth, as applicable.
- Maternal demographic information, reproductive history, concurrent medical conditions,
and concomitant medications/exposures
- Prenatal testing information
- Health Care Provider contact information
- Cymbalta therapy information (daily dose, start date, stop date relative to conception,
- Familial history of birth defects
- Pregnancy outcome information (live birth, stillbirth, miscarriage, etc.)
- Infant birth data and findings
- Assessment of infant growth and development and physical exam findings at 4 months
and 12 months
- Breast-feeding assessment at 3, 6, 9, and 12 months
Because this Registry is an FDA required post-marketing safety study, it is exempt
from HIPAA regulations (45 CFR-164.512). The Registry does require an abbreviated
consent document, which is completed by a clinical research associate over the phone
(i.e., an authorization for release of medical information and release forms). The
IRB has granted a waiver of documentation of informed consent, allowing patients
to provide this verbal consent to participate without a written signature.
How are data collected by the Registry?
Enrollment in the Registry is strictly voluntary. The patient can initiate the enrollment
process by calling the Registry and providing verbal consent for participation and
for contacting her healthcare provider(s). Once the patient provides her verbal
consent, data can be collected for enrollment. The patient's obstetric healthcare
provider is then contacted to confirm his or her willingness to provide follow up
regarding the patient's pregnancy. Alternatively, the healthcare provider can initiate
enrollment with a conversation about the Registry with the patient. The healthcare
provider has access to the Registry forms and may consent the patient in his or
her office and send the completed forms to the Registry. Subsequent follow-ups with
the healthcare provider and/or patient will be initiated from the Registry.
In order for the Registry to collect the best data possible, it is extremely important
for eligible patients to be enrolled early in pregnancy, preferably before any prenatal
testing has been conducted. However, eligible patients at any trimester of pregnancy
Data is collected by the Registry Coordinating Center on Registry data collection
forms. Click on
for more information about contacting the Registry Coordinating Center. Click
link to see the detailed data entry forms.
How are data analyzed and reported?
The Registry plans to produce an interim report for participating Health Care Providers
every 12 months to share the most current information from this ongoing Registry.
This reporting schedule is contingent upon the level of enrollment. The interim
report will continue to evolve as more data are collected and analyzed.
An important aspect of The Cymbalta Pregnancy Registry is the Scientific Advisory
Committee (SAC) formed to oversee the collection and analysis of Registry data and
the presentation of results. This independent SAC is composed of recognized experts
in the fields of teratology, epidemiology, maternal and fetal medicine, and therapeutic
areas of interest, from the CDC, academia, and private practice. The Committee’s
membership also includes non-voting representatives from Eli Lilly and Company and
INC Research, LLC. The SAC will advise on the Registry, as well as review and provide
interpretation and reporting of the cumulative data on an ongoing basis.