Why CRCO is the Key to Increasing Patient-Centricity

The environment in which biopharmaceutical and medical device companies conduct clinical trials has changed dramatically in recent years. From patient-centric healthcare models, to the increasing focus on the improvement of precision medicine-the digital age has certainly improved the clinical trial space.   With the use of technology, clinical research has changed from the once cumbersome, slow, expensive and transactional in nature process, to a process that is now fast, easy, and patient friendly. Although these improvements are a huge step forward, gaps still exist within the model due to often siloed hospitals and providers.   The need for a paradigm shift toward Clinical Research as a Care Option, or CRCO, is a warranted movement that will alleviate these gaps and foster a more inclusive clinical research environment. CRCO is about engaging everyone involved in clinical research – patients, providers, sponsors alike – to develop an ecosystem that is effectively a care pathway option available to patients when determining treatment.   Why is CRCO the key?   The answer is probably best summed up by one statistic: only 1 percent of the patient population in the U.S. is estimated to participate in clinical trials. Even in cancer, the most actively researched category in clinical research, less than 3 percent of patients participate. This is an astonishing figure when you consider how much of the world of healthcare, medicine, and the delivery of innovation is reliant upon the successes (and failures) of clinical research.   CRCO would change the equation for patients-putting them at the center of clinical trials; therefore, rebalancing the value for them to participate, not just as “subjects,” but as active participants who have access to and understand their own data. CRCO would also integrate research into the continuum of care, accelerating the speed of therapy innovation and reducing costs-creating a win-win for all parties involved.   How could CRCO benefit all of us?   For companies developing new therapies and for their patients, the adoption of CRCO as standard clinical practice would have dramatic ecosystem impacts, including:   1. Pharmaceutical companies could accelerate clinical research and cut R&D costs dramatically   Despite all of the technology on the market today, the rising R&D cost to get a new drug to market still persists-proving that Eroom’s Law is very much in play. However, the digital acceleration of clinical trials could drastically reduce costs, and could improve recruitment methods.   We already know that digital health accelerates preclinical studies and pilots by removing the need for actual study sites and by making them more accessible for any size or distribution of population. Add that to the fact that digital health can also accelerate recruitment and onboarding (which accounts for 40 percent of the $45B spent on U.S. trials each year), and increase patient engagement and retention, and the potential is amazing.   For pharma to continue their investment in life-saving therapies, we must cut the cost of getting those therapies to market. Deploying digital solutions with the right clinical operation patterns has proven to move the needle in this area. CRCO builds on these initial trends, and turns faster more effective clinical research by more quickly applying the research outcomes back into the care delivery system.   2. Provider organizations would be able to evolve into Learning Health Systems that deliver patient-centered care   Reforming standard clinical trial protocols more quickly, based on learning in clinical trials, could reduce the lag time between incredible findings and the release of those findings into the market. Patients would then have access to impactful new therapies sooner within a CRCO system. Increasing the number of participants enrolled in clinical trials would dramatically improve opportunities for large-scale learnings and quick reassessments of trial direction and content.   3. Patient populations would gain quicker access to treatment never before considered or accessible   Right now, most patients try several treatment plans before they land on a successful one. They can spend years trying one therapy after another before finding an appropriate fit. But in a CRCO system, consumers wouldn’t have to play this trial and error game. Ideally, in the future, a provider could simply look up a patient’s genome, determine that a certain therapy would not be effective, and move onto the next therapy.   How can we get there? Precision medicine and the consumerization of genetic counseling. Now that patients can easily and cost-effectively access their own genetic information; this information can also be integrated more easily into clinical studies. Integrating a population’s genetic data into clinical studies introduces the possibility of validating the success of therapies, based on individual sequences. With CRCO, it is possible to get these powerful therapies into the hands of providers quicker.   4. New research would engage patients in their own health and well-being   A study completed by PMG Research indicated that upon completion of a clinical trial, 95 percent of patients reported feeling more engaged with their overall well-being and more committed to their health than they were prior to their involvement in the study. Add this to the fact that access to one’s own health data can also improve health and behavior, and a CRCO model could help us dramatically improve population health overall.   What will it take to get there?   In order to deliver the goals of CRCO, we need to embrace the following shifts:

• A move to Adaptive Study Designs from “traditional” RCT Design

• A move to Big Data Prescriptive Analytics from “traditional” Predictive Analytics

• A move to digital PROMs and Connected Devices from “traditional” ePRO and EDC systems

• A move to Personalized Medicine from “traditional” Cohort-or-Population-driven Medicine

The pace of change is accelerating in patient care, given the evolving importance of sophisticated digital health solutions, the acceptance of more flexible research protocols, and patients eager to participate if the process can work for them. The paradigm shift is nigh. CRCO is one potential outcome of effectively combining these amazing trends together. All of this will make for long-term, sustainable optimization and evolution in clinical trial operations and care delivery overall.     This blog is adapted from Medullan’s blog on this topic

http://ideas.medullan.com/blog/clinical-research-as-a-care-option-a-worthy-goal-for-digital-health

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Ryan Rossier

is VP of Platform Solutions, Medullan