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Global health care in the 21st century is increasingly focused on structuring health care systems around value for the patient. That value can be measured by cost effectiveness, knowledge gained from the practice of evidence-based medicine, and other key concepts.

At Lilly, we believe that the results and practice of clinical research can help support value-based health care delivery. Knowing that it will take cooperation across health care systems, the pharmaceutical industry, and academia to develop feasible solutions, we have recently collaborated with representatives from Wilmington Health, PMG Research, Quintiles, Pfizer, and Harvard to investigate the impact of clinical research on health care overall.

Below is a brief summary of what we found.

Patient Survey Findings

The basis of this idea is supported by results of a recent and ongoing survey.

To assess the impact of an integrated, collaborative approach to health care, we conducted a survey of participants in a 4-year, ongoing clinical research trial for diabetes. Of the 45 randomized study participants, 42 were able to respond to the 14 survey questions. Surveys were completed in January 2015 and again in July 2015, with repeat survey assessments planned for 2016, 2017, and 2018. In addition to comparisons across time within the patient cohort, we created a national baseline average of over 4,000 patient surveys using the same set of questions from January 2013 through June 2013 (dates were purposely chosen that precede the start of the ongoing clinical trial in our current survey).

The survey results consistently demonstrated a high and increasing level of patient satisfaction and engagement with clinical research, including satisfaction with access to care, efficiencies in care delivery, and the quality of care provided by the research staff.

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More specifically, when asked about their clinical research experience with regards to their engagement in their own health care, the quality of their care during the trial, and the cost benefits of trial participation, respondents were overwhelmingly positive, as shown in the following image.

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Figure 1. Benefits of clinical research participation.
Used with permission. Quintiles: Clinical research participation as a care option. 2015. [Whitepaper]


These findings — direct from trial participants — inspired us to pursue the goal of making clinical research a readily available care option.

Literature Findings

Currently, less than 1% of the US population participates in clinical trials, yet 72% report that they would participate if their care provider recommended they do so. It is difficult for patients to learn about clinical research opportunities, find out what may be best for them, and have a physician willing to discuss the options with them. Especially with the rise of ePatients and recent technology advances, patients want to engage in the health care system, have informed discussions with their health care providers, and take responsibility for their health outcomes. Ironically, clinical research — the engine that supplies new treatments and can help drive better outcomes — is often treated as something apartfrom health care rather than a partof health care.

Clinical trials should be looked to and leveraged as medical care options that have the potential to improve overall health outcomes, going beyond achieving the clinical endpoints for which they are designed. This paradigm shift will arise only from collaboration among patients, healthcare providers, health care systems, drug developers, and policy makers to realign clinical trials to center around the needs of the patient, not just around the collection of clinical data.

When the model is structured to reward patient-centricity, new opportunities emerge to reinvent the value proposition for clinical trials, and clinical research can be more readily integrated into the overall continuum of care.



*Katherine Vandebelt is the Global Head of Clinical Innovation at Eli Lilly and Company