Four Key Considerations for Long-Term Patient Registry Design

Four Key Considerations for Long-Term Patient Registry Design

One of the biggest operational challenges with the design of registries, also called post-approval safety studies (PASS), is understanding the differences with clinical trials. Clinical trials involve subjects with very specific inclusion/exclusion criteria and protocol procedures, but registries take “all comers” with limited inclusion/exclusion criteria seen as part of routine care. Often sponsors design what they believe is a registry but is actually a post-approval study based upon clinical trial guidelines and SOPs.

There are four specific areas that deserve consideration when developing a long-term registry:

1. Site Identification
A robust feasibility study is key to successful identification of sites. Look for dedicated staff for long-term commitment, actual patient population, and use of the product associated with the registry. Utilizing community-based physicians shortens timelines by providing quicker start up and faster access to “real world” patients. All relevant information should be analyzed and supplied to the sponsor with a list of the “best” sites for a registry.

2. Patient Identification
One MAJOR difference between clinical trials and registries is patient enrollment must occur naturally in a registry – without recruitment. These patients must be seen as part of usual care for the disease process, no additional visits or treatments can be added as this may cause the institutional review boards/ethics committees (IRB/ECs) to classify the program as interventional. Encourage sites to review charts prior to site initiation visits (SIV) to pre-identify patients. Sites should also perform a daily review of appointments.  Finally, since these are patients of the treating physician, the physician – patient bond is seen as integral to patient enrollment in any project.

3. Patient and Site Retention
Over the long term there can be staff turnover at sites, registry “burn out” or a site determining the registry is no longer cost effective enough to utilize valuable resources. Site management teams should perform routine communications with the sites (at least monthly) with specific touch points, thereby keeping staff engaged. Finally, reiterate to sites that only minimal data is needed, usually related to safety. This can be gathered at routine visits, so additional work is not required.

Patient engagement over the long haul often sees the same pitfalls as sites.  “Burn out” can occur over time as patients lose interest or move. Creating options to collect limited safety data on an annual basis, and when necessary, to minimize perceived patient burden can be an effective way to handle these issues. In recognition of patient movement, sites should collect secondary contact information at time of consent and ask that this be updated on an annual basis. Building data systems to allow for the transfer of a patient from one site to another, which may be needed for a patient who moves or a pediatric patient who moves off to college, is another way to manage this issue.

4. Data Requirement Determination
Registry data needs to be in line with routine care. Data points around visit schedules need to be seen as a guideline based upon disease schedule. Sponsors should expect to collect data at the visit that most closely hits a protocol visit, e.g., a 6-month visit may actually be a 7-month visit. Do not query for visits considered to be outside a normal treatment window. The bottom line is to gather ONLY what is needed. If data will not be used – leave it out.

Overall planning for a long-term registry needs to start with the endpoint in mind. Thinking through the entire process will help identify potential issues or pitfalls so they can be addressed in the planning stages, maximizing overall success of the registry.