Worldwide Partners with Datavant to Improve Clinical Trials in ALS, Other Diseases
In the U.S. alone, the estimated annual cost of nine common neurological diseases currently totals about $800 billion. This will increase even more, with the population of elderly Americans expected to double by 2050, to about 83.7 million people.
These disorders have a gradual onset, with their symptoms evident only after a significant loss of neurons. As a result, scientists face important challenges in drug discovery and development.
The collaboration uses the expertise in neurodegenerative diseases and clinical trials of Worldwide, a clinical research organization (CRO) involved in ALS research, with Datavant’s focus on healthcare data.
“The promise of advancing drug development and unlocking novel opportunities for innovative trial design and interpretation is particularly important, as we strive every day to improve the lives of patients and populations suffering from the complex ravages of neurodegenerative disease,” Peter Benton, president and chief operating officer at Worldwide, said in a press release.
The companies will study why clinical trials fail, the potential of real-world evidence and vast amounts of information — big data — to improve trial design and methods, and the use of digital technology for extended trial monitoring.
Current obstacles faced by clinical trials, such as the slow enrollment of participants, low patient engagement, inflexible study design, and the inefficient use of real-world evidence, will also be evaluated.
Worldwide’s scientists will provide insights into disease processes and new strategies for clinical trial designs and operation. Datavant will contribute with its holistic approach to link real-world medical information with that of other sources, including socioeconomic data, behavioral data, and wearables and devices.
The companies will initially design a high-profile pilot study to improve trial monitoring by focusing on patient compliance, adherence, and enrollment feasibility.
“The challenges that continue to persist in neurodegenerative diseases highlight the need for novel and evolved approaches to understanding both disease mechanics and patient progression,” said Travis May, co-founder and CEO of Datavant.
“We believe our partnership with Worldwide takes an important step to revisiting and improving upon elements of trial design and operations that have remained stubborn barriers to progress in the field,” he added.