Patient Registries offer unique and creative solutions in a pre and post-launch environment. Used for the collection of observational, epidemiologic, actual use, health outcomes, economic outcomes data. Utilizing the web, phone, email, paper mail, strategies, our Registry services provide a fast and one-stop solution.
Randomized Clinical Trials are not the best instruments for many research questions posed for healthcare products, drugs & devices. They often, and by design, driven by atypical use patterns, narrowly defined populations, encounter unusual medical practice. These are also analyzed by methods not well suited for real-world use. In the simplest form, these trials give minimal if any insight into the who/why/how of product use. Generally, these study populations are small, and not at all well suited for outcomes analysis.
When developing a patient registry program, the careful design will yield extremely useful outcomes data. Properly designed, prospective studies, appropriate real-world selection criteria, *observational* trials are a hallmark of the most useful registry programs.
Points to remember;
Efficacy trial vs. Effectiveness observational study
Clinical or Cost Effectiveness
Measure or Monitor Safety
Real-World Healthcare Observational Parameters
We'll begin designing a registry study by first understanding the product in a comprehensive fashion. Understanding if and how a patient registry will offer outcomes data to the product. We need to look at the patient outcomes variables, the defining questions for those variables, the natural history of the disease, specifics on patient care and disease management. The program then turns to a detailed examination of registry purpose, observational metrics to accomplish that purpose, carefully constructing the instruments to that goal.
Designing a program is only part of the challenge. Implementing a patient registry is not simply another clinical trial, or a phase IV trial. Treated as such, will not produce the same results, nor yield the most useful data for the sponsor.
Recently the Agency for Healthcare Research and Quality, AHRQ, released the 2nd edition of: "REGISTRIES FOR EVALUATING PATIENT OUTCOMES: A USER'S GUIDE"
Synergy Research Patient Registry Services