More than 80% of clinical trials in the U.S. fail to meet enrollment timelines and are stopped early because they can't enroll or retain enough patients throughout the trial in order to develop a sufficient data set, according to the National Institutes of Health.
Enter big data, which is quickly emerging as an answer to this high failure rate by streamlining the clinical trial process and matching patients to trials more effectively.
U.S. pharmaceutical giant Merck recently announced a partnership with Maccabi, the second largest health organization in Israel, to use their data to track disease progression and medication effectiveness over a patient’s lifespan. The multi-year agreement is one of several initiatives that show the importance of big data in managing disease treatment.
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Maccabi was of particular interest to Merck because of its history collecting patient data -- it has been using electronic health records for more than 20 years, painting a longitudinal picture of the evolution of patients' health over lifetimes. Israel's healthcare structure also makes Maccabi a good fit. Maccabi is one of the four Israeli health organizations that were created under the country's 1995 National Health Insurance Law, meaning Maccabi's patient base represents nearly 25 percent of the Israeli population.
Another advantage is Maccabi's Israeli origins, or rather the fact that it's not a U.S. company.
"There's reticence in the United States to give anyone access to any data," said Ira Kalina, a partner at Drinker Biddle and Reath, a U.S. law firm that has a healthcare division. "It would be a PR nightmare."
All of the patient data is de-identified. As a result, Merck and Maccabi didn't need patients' permission to use their data.
"Part of the goal is to understand with greater granularity the natural history of treatment and disease, and how medications benefit certain patients and sub-groups of patients," said Sachin Jain, Merck's chief medical information and innovation officer.
One of Merck's initial uses for Maccabi's data will be looking at the progression of osteoporosis.
"Traditional recruitment and enrollment into clinical trials is unfocused, laborious and expensive," said Lisa Griffin Vincent, president of PatientPoint Outcomes Research Solutions, a healthcare technology company that has partnered with Miami Children's Hospital to develop clinical trial data technology. "Recruitment methods typically include clinic staff poring through paper clinical charts page by page to identify patients that may meet the trial eligibility criteria. Access to big data can transform and accelerate the clinical trials process if leveraged in the right ways."