By 2020, large pharmaceutical, biotechnology, and contract research organizations (CROs) plan to increase internal staff dedicated to real world data collection and analysis by 25%, according to the survey conducted by Tufts Center for the Study of Drug Development (Tufts CSDD).
With the passage of the 21st Century Cures Act passed in December 2016, the US Food and Drug Administration (FDA) was required to develop a framework and guidance for RWE within drug development in two years.
“The FDA is mandated to expand the use of RWE in regulatory decision-making,” Mary Jo Lamberti, PhD, senior research fellow at Tufts CSDD and lead investigator on the study said.
“Data gathered directly from patients can be used to improve our understanding of diseases and could potentially result in improvements in the clinical trial process,” she told Outsourcing-Pharma.com.
According to the study, the primary users of RWE are commercial functions within drug development organizations, though 40% of research and development operations also rely on it.
“We asked companies to evaluate their use of various categories of data to support an NDA [new drug application] and we found that social media data was expected to be used by 42% more companies in 2020 compared with 2017,” Lamberti explained.
Demographic data, biomarker/genomics data, patient-reported outcome and survey data, as well as data from data from personal health devices/wearables, are also sources of data where companies projected growth in usage, she said.
However, data availability was cited by 60% of the respondents as the greatest challenge in using RWE. Other challenges named include lack of external stakeholder trust in RWE – “especially from regulators and payers,” Lamberti added.
Data acquisition and integration costs, determining causation, in addition to quality and reliability of claims and electronic health record data were also named as challenges.
“RWE is now being used by pharmaceutical companies primarily within the post approval regulatory and labeling areas, in particular, post approval for safety assessments, including decreasing the severity of a label warning or to support risk evaluation and mitigation strategies,” said Lamberti.