EnrichMap’s Focus:
EnrichMap focuses on proactively managing adherence to treatment regimen in clinical trials by identifying, prior to enrollment in the study, groups of patients based on their behavioral patterns pertinent to compliance and providing pragmatic, group-specific strategies to minimize unnecessary treatment failures caused by noncompliance and, in turn, reduce the consequent morbidity and mortality, research confoundments, delays, and financial waste.
Fundamental to all EnrichMap tactics is a commitment to actively support the patient’s autonomy and authority to choose whether to follow specific treatment recommendations.
Background: Adherence In Clinical Trials
Noncompliance exerts an especially significant impact on medical research. Even when aggressive screening techniques are used, adherence remains problematic. Moreover, screening tactics such as placebo run-in periods add their own time and cost demands to the project.
Observable compliance failures dramatically increase the number of patients required for a valid statistical sample of sufficient power while covert noncompliance distorts data and causes errors in clinical conclusions.
Given the powerful effect medical research has on the development of pharmaceutical and other treatment methodologies, noncompliance wields great leverage in increasing healthcare expenses. For this reason, clinical trials are enticing targets for compliance-enhancing tactics; because of the controlled environments, large patient groups, and built-in data collection methods, clinical trials are also attractive laboratories for exploring noncompliance itself.
The absolute and proportionate cost of clinical trials is increasing faster than any other expense in the development of new drugs. Currently clinical trials account for approximately 50% of the billion dollar cost for new drug development and projections indicate that the trend of increasing costs for clinical trials will persist.
Developing the Emap Profile
EnrichMap recognized that the disproportionately powerful significance noncompliance held for clinical trials made such research a potentially important beneficiary of The Emap Profile, a survey tool that identifies the likely responses to treatment recommendations based on a patient’s inherent compliance tendencies.
By using the Emap Profile Survey at a pre-randomization stage of the trial, decisions could be made about which candidates best fit the needs of a particular study and how the different groups of patients accepted into the study should be managed to optimize treatment protocol adherence. Successful implementation would both reduce costs and bring well performing medications to market faster.
Moreover, clinical trials, by their nature, offer incomparable advantages as a laboratory for validating hypotheses about compliance and compliance enhancement that may be applicable to healthcare in general.1
EnrichMap’s excitement about these prospects has eventuated in the roll-out of the Emap Profile.
Footnotes:
- Initial research-based implementations of the Emap Profile are, in fact, available at a discounted price. See Using The Emap Profile [↩]
