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.
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