The pharmaceutical industry is estimated to spend over $50 billion a year on the research and development of new drugs, and the cost of bringing a new drug to market is estimated at $1 billion. Each day a drug is delayed from reaching the market, the sponsor loses up to $8 million. Only six percent of clinical trials are completed on time, and 72% of trials run over schedule by more than one month. Only one in five drugs is approved for sale in the U.S., which has a direct impact on ROI for drug manufacturers.
Clinical trials form the largest cost center in new drug development, and 30% of these costs are associated with handling patient records. Data collection and management activities account for about 60% of the total time within which Phase I-III trials are conducted.
According to the New England Journal of Medicine, clinical trials report average adherence rates of only 43% to 78% among patients receiving treatment for chronic conditions. Poor compliance makes it difficult to detect therapeutic effects, affecting the manufacturer's chance for getting the drug to market. Noncompliance costs pharmaceutical companies $30 billion in lost revenues and $8 million to $40 million per drug trial. It costs an average of $6533 to recruit a patient for a trial, and three times that amount to recruit a new patient if one is lost due to noncompliance.
Research suggests that a high-tech, high-touch approach is required in modifying patient behaviors surrounding adherence. Thus, adherence interventions require a sound technological approach coupled with a deep understanding of patient behaviors, health beliefs, and behavior change.
A study done by ExpressScripts examined principles related to the design of more effective therapy management programs. They found that financial incentives alone had limited effect in changing consumer behavior. The addition of psychosocial elements, such as message framing, to therapy management programs had a significant effect in increasing the switch rate to generic simvastatin. Other research by Leap of Faith Technologies funded by the National Institutes of Health, suggests that patients want technology-based adherence interventions that fit seamlessly into the way they already live and that use familiar technology to enhance self-efficacy. As a result, eMedonline was developed as an intervention that delivers sustainable mobility to the patient on a familiar platform, while enhancing data quality and supporting automation efforts in drug delivery.
eMedonline cost-effectively and accurately tracks drug distribution, dosing times, and missed doses, eliminating costly uncertainty about efficacy and the need for manual data entry. This can reduce the cost to bring a drug to market and speed the time to market, enabling drug companies to maintain their market position.
The eMedonline platform is flexible and supports an evolving solution defined by a combination of:
Patient characteristics — eMedonline supports a range of disease states, patient demographics, physical capabilities, and preferred messaging style.
Roles in care management — eMedonline supports a range of customizable user roles
Application services — eMedonline provides a full range of services (e.g., medication adherence tracking, reminders, education/training, disease & therapy experience tracking)
Technology types — eMedonline supports various technology types: pre-configured smartphone, customer smartphone, tablet, custom or alternative device (e.g., Internet appliance)
Distribution & support models — eMedonline accommodates a range of models (e.g., shipped by vendor, shipped by pharmacy, tech support, case management).
eMedonline complements the therapeutic portfolio of pharmaceutical companies. It offers the potential to differentiate products in a competitive environment, and allows companies to collect compliance data in real time, correlate compliance with outcomes, and substantiate label claims. In this way, it is possible to track drug use, map adherence to outcomes and dosing, and automatically collect data for predictive modeling.
Features that Support Pharmaceutical Applications
- Theory-based intervention, using models of health beliefs and behavior change in its design
- Built upon existing technology platform that is accepted and valued by the patient population
- Extensible to other platforms (e.g., PDA, Internet appliance)
- Leverages and builds upon existing and emerging technologies (e.g., smartphones, barcodes, RFID)
- Scalable and easily deployed
- Provides sustainable mobility to the patient
- Helps patients identify the right drug at the right time to prevent medication errors and mitigate side effects
- Creates a touchpoint with the patient/prescription/treatment
- Operates wirelessly in both online and offline environments (i.e., disconnected from the network)
- Delivers real-time, patient-specific, data on medication use and patient health status
- Provides information and feedback to the end-user
- Feedback strategy incorporates principles of tailored messaging and message framing
- System offers customized regimens, schedules, and adverse event monitoring
- Specific patient behaviors can be set to trigger alerts to various stakeholders
- Solution includes "back end" web services and an interface that allows clinicians and stakeholders in product delivery to monitor drug use, adherence, and adverse events
- Adherence metrics are automatically collected, summarized, and reported in real time
- Data can be exported to other clinical monitoring systems or data warehouses, and integrated in real-time with such systems
- Patient data can be integrated with personal health records
- Design addresses low literacy concerns and has demonstrated ease-of-use among low literacy populations
- Design has demonstrable acceptance by end users
- Design has evolved from thorough, peer-reviewed ethnographic research involving needs assessment and focus group research involving patients, providers, pharmacies, pharmaceutical service providers, and caregivers
References:1 "Optimizing the Clinical Trial Process: Strategies to Reduce Costs and Increase Quality." Datamonitor, Date: May 2003.
5 RB-171. The Clinical Trials Business Communications Co., Inc. Norwalk, CT. May 2003.
6 Lars Osterberg, M.D., and Terrence Blaschke, M.D. "Adherence to Medication." N Engl J Med 2005; 353:487-497 August 4, 2005.
7 Schering Report IX "The Forgetful Patient: The High Cost of Improper Patient Compliance."
8 Improving Patient Compliance: Utilizing online and mobile compliance tools. Datamonitor Report. July 16, 2003.
9 Cutting Edge Info.
10 Learner, N. PBMs, Specialty Pharmacy Vendors Focus on High-Touch Rx Management Strategies, AIS. Reprinted from Drug Benefit News, July 7, 2008.
11 Rapchak, B. Presentation. NCI SBIR Showcase: Linking Science and Business. Washington D.C. Oct 7, 2008.