Eye For Pharma: Cognizant’s Senior Vice President and EBA Venture Partner Writes About Transforming Clinical Trials Via Patient “Code Halos”

“In response to the many pressures to become more efficient and the increasing scrutiny of regulators and payers to demonstrate real-world evidence that new medications are truly effective, pharma are focusing on how to leverage technology to transform clinical trials,” writes Nagaraja Srivatsan. Excerpts from the article:

“Clinical trials are seldom ‘patient-friendly’ and this lack of ‘personal connection’ contributes to poor medication (or exercise/diet) regimen adherence and high drop-out rates. These factors in turn contribute to delayed or interrupted trials or confounding data that make trial results suspect.

Our belief is that clinical trials can be made more effective, efficient and patient-centered through the application of what we term patient ‘code halos’. ‘Code Halos’ are the field of digital information that surrounds a person, place or thing—e.g., a ‘virtual patient’—from which significant clinical value can be derived and measured. Code Halos are generated by patients as they move through the healthcare and clinical trial ‘ecosystem’. In general, patients generate Code Halo data around:

- “Quantify Me”: including vitals measurements, health surveys, social interactions, etc.

- “Information of Things”: including biosensor data, application data, web data, wearables

- “Information About Me From Others”: including EMR/PHR data, adherence data, prescription data, care planning and management data

This is information is nice to have, but to make a patient Code Halo useful as a mechanism for transforming clinical trials, we need to use the data in the Halo to understand the patient and then influence and modify patient behaviors through that deep understanding throughout the trial beginning with the enrollment process.

We see this process of behavior modification as a five-step, continuous process that is deeply enabled by technology:

1. Patient Stratification

2. Self-Help and Education

3. Deliver Insights

4. Interventions

5. Monitor Outcomes

To accomplish this, Cognizant has implemented an integrated, modular solution for clinical trials called Cognizant HealthActivate℠ comprising 11 modules designed to understand the patient, engage with the patient, provide the appropriate level of virtual and real interventions—all to influence their behavior for the right outcomes.

We believe that patient Code Halos are the key to changing trial patient behaviors to reach the right outcomes and are the essential element to tailoring and targeting the appropriate technology-based and human-based interventions to overcome many, if not all, of the human-based behavior issues that are problematic for clinical trials.”

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