Post-Marketing Programs

PRA's Late Phase Services group has a wealth of experience delivering successful post-marketing programs of varying types and designs. These services include:

Disease Registry—Follows a group of patients having the same condition, regardless of treatment, over time. Mostly prospective (starting at enrollment and forward in time) but may collect some retrospective information (prior to enrollment back to diagnosis of condition). Disease Registry collects a significant amount of information over time to determine disease, treatment, quality of life (QOL), health economics, and safety fluctuations.

Product Registry—Follows a group of patients exposed to the same treatment, regardless of condition, over time. Mostly prospective but may collect some retrospective information. Product Registry collects a significant amount of information over time to determine disease, treatment, QOL, health economics, and safety fluctuations.

Pregnancy Registry—Follows women exposed to a product while pregnant; mostly prospective until outcome of pregnancy or until the child reaches a particular age. Most collect some retrospective information.

Safety-Surveillance—Similar to a Product Registry, as it follows patients exposed to the same treatment. Most have similar prospective and retrospective approaches as well. The major difference is that the size of the study is dependent on the rarity of the "Event of Interest." These types of studies attempt to determine if exposure to the product increases the chances of having one or more health outcomes (MI, life-threatening respiratory event, etc.). These studies contain well defined outcomes and are related to the profile of the product.

Restricted Access Program—Patients are not given the product unless they have been registered in the program. Some require prescribers, pharmacists, and distributors to register as well. Data is collected while the patient is using the product.

Health Economic—Main focus is to collect health utilization and expense information on the product and other health services. Health economics looks to determine if use of a product results in a better health outcome and could be used to support formulary acceptance for a product.

Retrospective Cohort—Follows a group of participants from enrollment back in time. It usually requires extraction of information from medical records.

Case-Control Study—Compares people with a disease to another group of people from the same population who do not have the disease or condition ('controls'). A case-control study can identify risks and trends while suggesting some possible causes for the disease or for particular outcomes. These studies are always retrospective and useful to study rare diseases.

Randomized Control Study (RCT)—A study which allocates people at random to receive one of several clinical interventions. One of these interventions is the standard of comparison or control. The control may be a standard practice, a placebo, or no intervention at all. Since the outcomes are measured, RCTs are quantitative studies. Most clinical trials (Phase II and Phase III) are RCTs.