Decentralized trial and registry patient-engagement software to generate Real World Evidence for the Life Science Industry.

Industry has great difficulty evaluating the real world patient experience. Clinical trials are not typically comparative and they tend to exclude patient comorbidities. Health outcomes can only be effectively measured if real world observational studies are performed that show how chronic disease patients with other conditions respond to treatments in conjunction with and compared to other forms of treatment. This information can be used by industry to demonstrate comparative effectiveness, payers to govern reimbursement, and managed care healthcare providers to track pay-for-performance clinical quality measures.

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Payers are demanding that pharmaceutical companies and medical device firms demonstrate comparative effectiveness to govern reimbursement. Healthcare reform has heightened the demands on industry. As a result, comparative effectiveness research (CER) is becoming mandatory to support new and existing drugs and devices. The most valuable CER is in the form of real world patient reported outcome observational studies which evaluate the impact of treatments on patients' lives and healthcare utilization.

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Drugs and medical devices have many unwanted side effects and complications. Some of these are severe. Some reduce adherence to care and worsen health outcomes. And, many occur between office visits and remain undocumented. Mild to moderate side effects can only be measured through real world observational studies.

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Real world patient reported outcome studies create a body of knowledge on treatment response that facilitates the development of clinical guidelines for new drug uses, new label indications, and potentially whole new products and treatments for unmet needs.

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Linking PROs with clinical information in EMRs creates a holistic view of patient care. The EMR may show what was prescribed and claims data explains what happens to patients, but neither addresses "why" patients behave in a particular way. That's the province of patient reported outcomes (PROs). For example, the EMR shows what meds were prescribed and claims data may illustrate that patients did not fill their prescriptions. PROs may assess why patients didn't take their medications: side effects, fears, cost, what others may have said, et al. Taken together, researchers can develop a more complete understanding of treatments and patient response.

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