Real World Clinical Evidence
Registry studies utilize a new research methodology which combines the quality of a randomized controlled clinical trial (RCT) with the real-world benefits of observational studies. This approach allows our team to deliver the weight of evidence an RCT can provide with faster timelines and a budget-friendly approach.
Traditional RCTs provide the gold standard of efficacy evidence for supplements and medications, but these come at a cost. RCTs can become expensive, are accompanied by lengthy timelines, and have limited real-world generalizability. A registry study applies the same rigorous methodology to real-world environments allowing evidence of effectiveness with pragmatic applications.
What is a Registry Study? Rather than recruit new patients for randomized controlled trials, registry studies collect high quality data from clinicians and healthcare providers who are already using your products with their patients. This observational method allows the same high quality studies to be conducted much faster and at a much lower cost than conventional RCTs.
Benefits & Challenges with Registry Trials
Because registry studies use real world patients in natural settings, they can be completed in shorter timelines and are budget-friendly.
Timelines and costs are dependent on the effect size of your product and the nature of your network of clinicians. A typical registry study can be completed for as little as 10-30% of the cost of a natural products RCT or as little as 2% of the cost of a pharmaceutical RCT. Timelines can be as short as 2-3 months or as long as 5-10 years, producing multiple publications each year.
Registry studies require careful planning with the end goal in mind. Many existing registries are insufficient for study with data collection errors ranging from lack of proper baseline/outcome measurement to failure to collect the right variables for key research questions.
Our team designs your project with an emphasis on proper measurement of baseline and outcome variables, accuracy, and scientific methodology.
Traditional RCTs have stringent inclusion/exclusion criteria, limiting the populations to which the findings can be applied. This produces data on efficacy, but not necessarily effectiveness.
Thanks to the wider inclusion criteria required for registry studies, findings reflect real world diversity and have much wider applications to the general public by producing evidence of effectiveness.
Without the proper research design, the benefit of pragmatic studies can become a weakness. Real world practice involves a lack of blinding, variations in patient follow-up timing, and non-standardized implementation of treatment protocols.
Our experienced team develops your registry to achieve your end goals, ensuring that your study meets rigorous methodological standards.