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Pregnancy Registry Strategies in Late Phase Development

The number of patient registries is increasing in general and, more specifically, the number focused on biopharmaceutical product safety.

This increase arises in the wake of highly publicized litigation surrounding the safety of marketed products and new U.S. government legislation enhancing the powers of the U.S. Food and Drug Administration (FDA) to request that safety studies and studies in special populations be conducted. Now more than ever, registries are being used in the post-approval phase to further define the risks and benefits of medicinal products in various patient populations that go beyond the scope of clinical trials. Registries are being used to provide supporting data for risk evaluation and mitigation strategy (REMS) and to enhance labeling.

Pregnancy registries are a versatile risk management tool for assessing the safety of drug exposure in pregnancy. When a drug first comes to market, little is known about the safety profile of that drug when used in pregnancy. The required preclinical studies can only offer clues to the human teratogenic potential of a drug, and clinical trials exclude pregnant women unless the drug is specifically intended for use in pregnancy.

Pregnancy registries provide a unique means of risk assessment early in the life cycle of a product when other safety evaluation methods are not available. Pregnancy registries are ideally suited for products with a high likelihood of use in women of child-bearing potential. These registries may be particularly important for drugs in which preclinical studies suggest risk, or for first-in-class drugs or biologics. Pregnancy registries also may be useful later in the product’s life cycle when case reports suggest risk or new indications are added.

A pregnancy registry is a voluntary observational study of women exposed to a particular biopharmaceutical product at the time of conception and/or during pregnancy. Ideally, pregnant women are enrolled in a pregnancy registry as soon after the drug exposure as possible. They are then followed throughout pregnancy to capture data on the pregnancy outcome. Infants also may be followed to capture data on birth defects, developmental deficits or other adverse outcomes. The prospective nature of pregnancy registries makes them ideally suited for the study of new-to-market products that have not yet achieved high market penetration – products that are not well-represented across automated databases.

Pregnancy registries are typically patient-centered rather than site-based. Therefore, registry awareness activities should reach out to pregnant women and their health care providers in a broad variety of settings. The internet and social media are important recruitment sources for pregnant women, and personal mailings and scientific venues are important recruitment venues for health care providers. More and more, technology is being used to facilitate patient recruitment and ease the burden of data collection. 

A limited number of technology solutions available on the market are suited for a pregnancy registry because they are patient-centered and offer patient recruitment, consenting and data management functions within one efficient package. The increasing adoption of electronic health records (EHRs) as a potential data source for pregnancy registries will be critical moving forward.

The preceding article, published with permission, is based on an article published in Touch Briefings.


 
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