A Patient-Centered Approach in Clinical Trials: Impact on Patient Retention and Costs
A Patient-Centered Approach in Clinical Trials: Impact on Patient Retention and Costs
May 4, 2018 | White Paper
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Key Insight
“Adopting a patient-centered approach in clinical trial recruitment offers greater potential for cost savings through patient education and engagement in research functions and retention of chronically ill patients."
Abstract
This white paper reviews patient-centered strategies for clinical trials and treatments, including their impact in reducing clinical trial dropouts and total costs. In particular, we analyze how adopting a patient-centered approach in clinical trial recruitment offers greater potential for cost savings through patient education and engagement in research functions and retention of chronically ill patients. In an era of value-driven healthcare and personalized medicine, the pharmaceutical industry is increasingly focusing on diversity in patient recruitment strategies. However, there is little discussion on maximizing patient retention in clinical research studies. Key obstacles to retention include functional limitations, limited access to care, lack of education and awareness regarding clinical trials, and lack of ongoing support. Patient-centered interventions, including increasing access to transportation, utilizing health information technology (HIT), and increasing stakeholder engagement, can drive efficiency and cost-containment initiatives. Informed and empowered stakeholders can be pivotal in maximizing enrollment of diverse patients in clinical trials and reducing study lengths and costs.
Introduction
Clinical trial costs continue to rise and recent estimates put direct costs for Phase 1-3 development between $50-$100 million. While some estimates of total costs that incorporate previous R&D costs, development failures, and estimates of opportunity costs to bring a therapeutic to market are as high as $2.6 billion, a recent Journal of the American Medical Association analysis of the average costs for cancer drug development was much lower, approximately $641 million. Regardless of the methodology used to estimate these costs, clinical trial costs are widely regarded as an inflection point for cost reduction initiatives and economic innovation. In particular, patient retention strategies to keep patients in trials has shown much promise for reducing avoidable costs to the clinical trial system.
"High clinical trials costs negatively affect the entire healthcare ecosystem."
Pharmaceutical Research and Manufacturers of America (PhRMA) suggests that rising clinical development costs are a major contributor to escalating drug costs. While the extent to which clinical trial costs affect drug prices is currently debated, as noted previously, it is inarguable that the costs incurred during development are passed on to drug pricing. The relationship between access, cost, and quality of care demands a deeper understanding of the effect of high costs clinical trials on patients’ access to novel treatments, affordable prescription drugs, and ultimately better clinical outcomes for patients. For these reasons, identifying inefficiencies within the drug development process, and especially clinical trials, is especially pertinent to the current discussion to reduce costs and increase quality of healthcare in the United States.
Although bringing novel drugs to market are a high priority, the pharmaceutical industry is faced with a number of barriers in conducting clinical trials to completion. These include complex research protocols, increased regulations and requests for safety data, and lengthy timelines. These additional requests require increased financial capital, lost opportunity costs, and increased demand for patient enrollment. This increased need for larger patient cohorts is concerning due to previous issues with patient recruitment and retention.
The Department of Health and Human Services (HHS) defines patient retention simply as the “amount paid to the patient for study participation, which might include financial compensation, reimbursement for travel, meals, etc.” Further, the HHS estimates $6,145 for all patient retention expenses in a Phase I trial. By definition, this estimate fails to take into consideration delayed or failed trials, lost time, or the costs necessary to re-establish trials. Taking a more holistic approach to estimating patient costs within trials, PhRMA estimates the costs to enroll and retain a patient in any phase trial at approximately $36,000 per patient.7 In particular, it is estimated that the per patient costs for Phase III and IV trials account for a disproportionately large fraction of this estimate: 74% of the total patient costs due mostly to the larger cohort of enrolled patients. These figures are expected to continue rising with the increased need for clinical trial participants, resulting in increased trial costs. In addition to the patient recruitment problem, increasing clinical trial costs are also attributed to patient retention challenges.
"Recent reports revealed a 30% dropout rate across all clinical trials."
Furthermore, of those randomized into a clinical trial, 18% dropped out before trial completion. As a result, only 15% of all clinical trials are able to retain enough patients to completion. This presents a large opportunity for the pharmaceutical industry to implement patient-centered recruitment and enrollment approaches as a cost saving initiative. For example, recruiting a new patient into a clinical trial when another drops out of the trial or is lost to follow-up poses a significant financial burden. In addition, the failure of clinical trials to recruit and retain an adequate number of patients can result in lost time and effort, lost financial resources, missing data that can skew the results of the clinical trial, increased time and length of the approval process, or even a cancellation of the study.
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Joseph Gaspero is the CEO and Co-Founder of CHI. He is a healthcare executive, strategist, and researcher. He co-founded CHI in 2009 to be an independent, objective, and interdisciplinary research and education institute for healthcare. Joseph leads CHI’s research and education initiatives focusing on including patient-driven healthcare, patient engagement, clinical trials, drug pricing, and other pressing healthcare issues. He sets and executes CHI’s strategy, devises marketing tactics, leads fundraising efforts, and manages CHI’s Management team. Joseph is passionate and committed to making healthcare and our world a better place. His leadership stems from a wide array of experiences, including founding and operating several non-profit and for-profit organizations, serving in the U.S. Air Force in support of 2 foreign wars, and deriving expertise from time spent in industries such as healthcare, financial services, and marketing. Joseph’s skills include strategy, management, entrepreneurship, healthcare, clinical trials, diversity & inclusion, life sciences, research, marketing, and finance. He has lived in six countries, traveled to over 30 more, and speaks 3 languages, all which help him view business strategy through the prism of a global, interconnected 21st century. Joseph has a B.S. in Finance from the University of Illinois at Chicago. When he’s not immersed in his work at CHI, he spends his time snowboarding backcountry, skydiving, mountain biking, volunteering, engaging in MMA, and rock climbing.