Cost-containment pressures in healthcare have led to more stringent requirements to demonstrate evidence of incremental value versus standard of care (SOC) by regulators and payers alike. Real-world evidence related to patterns and outcomes of care that complement traditional efficacy and safety data is increasingly warranted to ensure successful market access and product uptake, not only for biopharmaceutical products, but also for medical devices.
Time and Motion
Time and Motion (T&M) studies are observational studies designed to quantify efficiency-related outcomes associated with:
Efficiency, in addition to effectiveness, is a major value driver for many health care interventions. Time and Motion (T&M) studies are observational studies aiming to quantify time for a process by disaggregating it into its constituting parts to measure task durations.
As the evidence needs of diverse stakeholder groups increase, real-world evidence becomes invaluable to decision-making. The differentiating feature of novel medications, medical supplies, and devices, may be related to increased treatment or healthcare process efficiency as opposed to clinical outcomes.
Dr. Annette Stemhagen, Senior Vice President, Safety, Epidemiology, Registries and Risk Management, and Dr. Robert Sharrar, Executive Director, Safety, Epidemiology, Registries and Risk Management, led an informative tutorial on pharmacoepidemiology this week at the DIA Pharmacovigilance and Risk Management conference.
Time and Motion studies are an appropriate solution when the efficiency of a drug, medical device, or intervention is the outcome of interest. In the current environment of more stringent evidence requirements by regulators and payers alike, real-world evidence that complements traditional efficacy and safety data is warranted to ensure successful market access and product uptake.