Obstacles Slow Optimal Real-World Data Adoption in Clinical Trials

Although the clinical trials industry is rapidly adopting real-world data (RWD), significant barriers and challenges remain to accessing robust, primary patient data, which impacts the optimal use of real-world evidence (RWE), according to a new survey by Inteliquet of professionals from pharma, biopharma, medical technology, and medical device companies, as well as contract research organizations.

“Accumulating data is not the significant problem for [the life sciences sector]; accumulating the right data is,” said Marie E. Lamont, interim president and chief operating officer at Inteliquet. “There is a need to better organize and validate data to improve its RWE utility in our highly regulated industry.”

An overwhelming majority of respondents (91%) report they currently use RWD in clinical development and decision-making, and 84% have internal systems to capture and analyze RWD. On average, organizations polled use RWD in:

  • Clinical trial designs (65% of respondents)
  • Early research and development preclinical planning (52%)
  • Clinical development (52%)
  • Postmarket observational studies (50%)

Clinical Trials and the Future of Evidence Generation: CTTI’s Vision for 2030

From real-world data to mobile technologies and beyond, the clinical trials landscape is changing rapidly. Regulators are encouraging the use of innovative methodologies; data and tech companies are providing new platforms and tools; and with increasing access to new data sources, everything from recruitment to endpoints is evolving. In this ACRP 2020 session led by the multi-stakeholder Clinical Trials Transformation Initiative, join a conversation about the future of evidence generation, and the unique opportunities and challenges of the next ten years.

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Looking ahead, organizations surveyed said they plan to substantially boost the resources they commit to RWD:

  • 89% of organizations plan to grow their budgets in 2020.
  • Two-thirds (66%) said they will increase their budgets by 20% or more.
  • Nearly half (46%) said their budgets will increase by more than 40%.
  • At least 53% of responding organizations already allocate more than $100,000 per year to RWD.

Currently, the most common sources of RWD are electronic health records (used by 58% of respondents) and population health sources of aggregated data (used by 54% of respondents).

A large chunk of those surveyed (67%) said they see value in accessing data from mobile devices, social media, health apps, wearables, or other biometric devices, although only 49% currently use data from these sources.

Author: Michael Causey