“How can a CRO (contract research organization), better serve its clients by accelerating enrolling qualified patients into their studies?”
Cut to the punchline: Harvesting the potential value of managing clinical trials requires accruing (enrolling) enough participants. Yet many trials fail, or are too slow, to accrue. Data-mining, automated engagement of candidate participants, facilitating tasks for the investigators, and real-time performance monitoring can accelerate accrual to launch your clinical trial on time and budget.
Welcome back to TeloChain’s Real-World Healthcare Insights! This is the fourth episode in a series on how secure technology-enabled process transformation and strategy redesign can help you harvest the full value of healthcare services.
Last episode, we looked at one way to close the gap between the desired and delivered value of a healthcare service—via re-imagining the processes needed to deliver the service enabled by a technology platform, favorably impacting both numerator (results) and denominator (cost) of the value equation. (2) Today we address gap-causing pain points by integrating new processes into an existing strategy and platform to enhance their effectiveness.
How’s your (system) IQ?
Systems (data, processes, metrics, feedback, people, devices) are informed and defined by their intelligence: Given the business, intelligence encompasses gathering and mining data to transform it into information that can inform strategy. Once executed, intelligence allows us to monitor progress, and—circling back—inform improvements to future strategy or its implementation.
From the data, we extract what we need, informed by our purpose and goals - but it’s the usefulness (relevance and actionability) of information that transforms data to intelligence.
The process of gathering and applying intelligence to make decisions is complex and critical. Good intelligence is the culmination of a multitude of factors that, when applied in harmony, provide clarity and direction. Intelligence can determine what your goals should be and how to measure progress towards those goals. It can reveal risk so that you may protect yourself proactively. It can optimize your resource allocation, suggest areas of expansion, and allow you to target customers.
In healthcare, hundreds of millions of lives depend on gathering and applying the right intelligence. There are four key factors that comprise quality intelligence:
TeloChain has access to robust health data spanning 200 million lives. Our cloud infrastructure, custom platforms, and advanced analytics engines support processing the data to each project's needs. Our team spanning clinical, business, health economics, operations, and statistical expertise formulate accountable, self-improving action plans based on the best possible findings.
These key Intelligence factors are applied to the steps of gap-closure: Diagnose, Strategize, Redesign, Execute:
Use case: Clinical trial accrual accelerator
Let’s demonstrate our gap-closing Diagnose → Strategize → Redesign → Execute approach using the Intelligence Data, Tools, Agility, Experience framework on a use case involving a contract research organization (CRO) managing clinical trials.
Let's define some terms!
Screening: Identifying (1) patients who might be candidates for a clinical trial, based on their meeting basic criteria such as age, gender, diagnoses, and treatments; (2) physicians who treat patients like (1)
Qualifying: the process of matching a potential participant patient's demographic and clinical scenario to the trial's inclusion and exclusion criteria
Enrolling: the process of recruiting qualifying patients to a trial, informing them about the trial and the experience of participating, and gaining (and documenting) informed consent to participate. 'Enrolling' may also be applied to physicians who in turn recruit patients and/or become investigators in the trial
Trial patient participant: A person who has signed consent, been randomized or allocated to one of its cohorts, and has began or completed the activities specified in the protocol
Accrual: The number of participants enrolled
Below, a simplified schematic of a clinical trial: In the pre-trial phase, research questions are developed, focusing on a study population defined by inclusion and exclusion criteria. (3) As part of the study protocol (recipe), minimum and target sample sizes are calculated—this is the number needed to accrue. In the accrual phase, potential patient participants are recruited by direct marketing or physician referral, and screened for eligibility. Those who meet the criteria are invited to participate. Upon signing the consent, they are allocated to one of the treatment cohorts, and enter the trial phase. For additional 101 on clinical trials, see our first series. (4)
Fundamental to the success of any clinical trial is accrual—recruiting enough participants to meet the Protocol’s’ criteria for ruling success in or out (5). A review of 2007-2010 registered oncology trials found that half of Phase 3 trials closed prematurely due to insufficient accrual. (6) A review of cardiovascular trials that started between 2006-2015 found 11% were terminated early, with 41% of those due to inadequate accrual. (7)
CROs—tasked with designing, enabling, monitoring, and reporting some or all of a trial’s phases and activities—have established policies and processes, data sources, and work flows—in short, a set of processes enabled by a platform. So why are studies failing to meet enrollment minimums?
To answer that question, we have to use all the data, tools, agility, and experience (intelligence) at our disposal to close the gap.
Diagnose: Listening to the pain points our CRO is experiencing, we discover their platform as a whole is working well, but accrual is unacceptably slow. What’s needed is not a new platform, but accrual acceleration.
Strategize: Using the data and tools available to us now, as well as the extensive experience of the study sponsor, CRO, and TeloChain teams, we identify that:
Redesign: Now comes the work of making a plan to address the problems based on the strategies identified.The Redesign phase involves adding in or modifying certain accrual processes and data-flows to work smoothly with the CRO’s existing platform.
Execute: In this case, we identified that slow or inadequate accrual partially stemmed from an insufficient poolsize of potential participants (8). TeloChain’s access to 200M deidentified healthplan members’ medical/pharmacy claims enables casting a wider net to identify patient concentrations thus helping determine location priorities. A second pain point was the lack of time, training, and systematized approach to educating patients for our physicians. TeloChain addresses these concerns by providing needed data, hardware, and user interfaces to make it easy for physicians to initiate patient education and onboarding.
Additionally, using analytics, models and machine learning, TeloChain can identify potential participants based on criteria match, likelihood of enrollment and trial completion. This helps the CRO plan and execute the study more effectively and efficiently. By providing secure e-consent and secure document storage, TeloChain eliminates the time-wasting hassle factor of linking study documents. And attrition is prevented with engagement based on participants’ circumstances, health literacy, and preferences.
Accelerating accrual with intelligence encompassed understanding the problems to be solved, selecting the right data to solve the problems, designing a workable and efficient strategy that fit within the CROs existing structure, and implementing the solution while closely monitoring its success.
Next up: Close the value gap—and do it securely.
Is your intelligence giving you enough vision and clarity to learn from the past and prepare for the future? Join the conversation below or contact us to see how we can create an intelligence strategy for you.