The popularity of observational (prospective and retrospective cohort) studies has been increasing as the healthcare industry continues to demand more evidence-based initiatives. Understandably so.  Even though the process of bringing a product to market requires a thorough evaluation of efficacy and safety, clinical trials by design are inherently artificial in that they are, for the most part, non-reflective of “real world” practice or patients.

Real world practice typically does not allow for frequent, time-intensive medical appointments.  And rarely are the same assessments taken as commonly or frequently in the real world as in clinical trials.  Combine these factors with the facts that rarely are real world patients as sterile - free from co-morbidities and complex treatment combinations - or as compliant with their treatment as patients involved in clinical trials.  Thus, there is a rapidly growing need for data that is more reflective of the real world conditions in which your customers operate.

Cetus Group specializes in a variety of formats and sizes of observational research programs - retrospective chart audits or analysis and prospective patient registries are the most commonly used.  A well designed program, regardless of the size of the budget, provides many insights into real world practice, including those not observed prior to product approval.

For example:

• Demonstration of short- and long-term effectiveness
• Indicators of safety and tolerability in combination with other therapies
• Administration and usage fluctuations in dosage and frequency
• Short- and long-term outcomes
• Impacts on quality of life measures
• Cost implications for patients and payors

While observational, these types of programs can be designed to minimize inaccuracies to yield valid data which is very valuable and useful for our clients, and equally as beneficial to the participating physicians.  Community-based physicians interested in research typically do not have the amount of time or resources to participate in clinical trials.  Observational research is a good fit for them, and Cetus Group designs each program to produce maximum benefit not only for our clients, but also the participating physicians.