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.
Trials are the major contributor to the cost of developing new therapies and firms; and these costs are nowhere felt more than when it comes to recruiting and retaining qualified patients for trials. One global biopharma company acknowledged that up to 40% of its funded trials either never launched or were halted because of patient recruitment, retention or protocol non-adherence issues.
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’.
We know that patients (trial subjects) share many of the same concerns about enrolling in or participating in a clinical trial including poor understanding of the trial and their obligations as participants, poor adherence to medications, incomplete understanding of the medications they are taking (and possible adverse events), lack of personal connection to the trial team to answer questions or to address issues (often emotional) that arise during the trial that may affect the patient’s ability or mood and simple things like scheduling and meeting appointments. Collecting and recording trial data using paper logs or diaries can also be burdensome and inaccurate.
In short, 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. Recognizing this, many firms have launched initiatives to make trials more ‘patient centric’. But what does ‘patient centric’ really mean?
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 apply B.J. Fogg’s Behavior Change Model as a framework for interpreting the Code Halo data we receive from the patient, from their sensors or PRO entries as well as data from other trial stakeholders to tailor the right interventions and engagement mechanisms to encourage enrollment, keep patients motivated and drive compliance and adherence with medication and related trial regimens.
We see this process of behavior modification as a five-step, continuous process that is deeply enabled by technology:
1. Patient Stratification: Understand the patient’s beliefs and motivations for entering the trial. Employ analytics to stratify patients in a meaningful way for the trial – e.g., demographics, ability to perform the trial tasks, health literacy, etc. These patient strata (or cohorts) are critical for tailoring and delivering the appropriate levels of interventions and engagement throughout the trial using rules-based criteria to trigger relevant processes.
2. Self-Help and Education: At enrollment, use a tablet to provide each patient cohort with an appropriately tailored 2 minute video or animation that completely describes the trial, their disease, the medications they will be taking, required changes in lifestyle (diet, exercise) and the procedures they need to follow during the trial to record their information, use required devices and make appointments.
3. Deliver Insights: As the trial progresses, use the Code Halo to generate descriptive as well as predictive insights about the patient’s behaviors. Use these insights to deliver the right messages to patients that encourage the right behaviors at the right times.
4. Interventions: Using the analytics engine to identify behavior patterns from the Code Halo that signal potential drop-outs or medication adherence issues. Proactively reach out through ‘virtual coaches’ enabled by mobile or web technologies and/or live coaches/nurses who can reach out to the patient within trial protocol procedures to get the patient back on track.
5. Monitor Outcomes: As patients stay within the trial protocols, monitor the trial endpoints from the Code Halo data and use intermediate results in a way to adapt the trial in-flight or add additional study arms as outcomes become more evident.
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. Cognizant HealthActivate℠ leverages Social, Mobile, Analytics and Cloud (SMAC) technologies to deliver the right combination of services for true patient-centered trials. In addition, Cognizant HealthActivate℠ leverages Cognizant’s “Bring Your Own health Device” (BYOhD) platform which enables patients and investigators to use their own medical and wearable devices to generate and integrate a longitudinal patient record to enrich the patient Code Halo well beyond the traditional EMR or patient log.
This model for patient-centric trials and clinical trial transformation through Code Halos has, in fact, been empirically demonstrated in a trial run at Cognizant for employees with BMI > 28 employing the Fitbit device coupled with live nurse/coach interventions. After 23 weeks, the trial subjects who received BMI-based and activity-based stratified interventions – regardless of their initial BMI – ended up losing an average of 10 pounds and more than doubled their weekly steps from 33,000 to more than 73,000 steps. The control group that received no interventions rapidly lost interest after initial enthusiasm and ended up with no significant difference from the US norm.
In summary, 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.
Nagaraja Srivatsan is Senior Vice President, Venture partner, Cognizant a leading provider of information technology, business consulting, enterprise applications and business process services.
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