This month, Deloitte (NY, USA) published results of its third-annual pharmaceutical industry benchmarking survey, the National Evaluation System for Health Technology Coordinating Center (NESTcc; VA, USA) opened for sponsor-funded research and more!
In this latest installment of our regular monthly column, we summarize a selection of key real-world evidence industry developments that have taken place over the past month.
The news highlights:
- Industry collaboration seeks to address barriers to real-world data interoperability
- Focus of use of real-world evidence shifting to R&D: results from third-annual benchmarking survey
- Two new partners to advance patient-centric, real-world evidence initiative for aiding understanding of COVID-19
- NESTcc opens for sponsor-funded research to drive generation of high-quality real-world evidence
- FDA pilots ‘first-of-its-kind’ platform for sharing cancer trial PRO data
Parexel, TriNetX (both MA, USA) and Datavant (CA, USA) have announced their collaboration to securely connect Parexel’s study operations data – using Datavant’s privacy-protecting technology – with de-identified data from TriNetX’s global real-world data network, thereby streamlining access to site-level, real-world data. The partnership ultimately aims to ensure real-world data interoperability, supporting the development of richer, actionable insights informed by both clinical trial and real-world data to accelerate research.
Gadi Lachman, CEO of TriNetX, commented: “We have seen first-hand during the COVID-19 pandemic the potential of real-world data to transform the clinical trial process and bring new therapies to patients faster. This collaboration will enhance the use of real-world evidence at the site level where we see the closest interaction with patients.”
Deloitte (NY, USA) has conducted its third-annual pharmaceutical industry benchmarking survey, to track trends in strategic focus, investments, challenges and opportunities for delivering value with real-world data and evidence, for which realization of return on investment has varied significantly.
In this year’s survey, 70% of respondents reported that a lack of research-grade real-world data is hindering use of real-world evidence in pharmaceutical R&D. Despite this, however, 94% of survey respondents attested that they believe using real-world data and evidence in this area will become important to their organizations by 2022. In addition, it is expected that, over the coming 2–3 years, the industry will shift its focus on its use of real-world evidence and expand this beyond traditional and current uses, such as in post-marketing surveillance, particularly within the R&D field.
Two new partners to advance patient-centric, real-world evidence initiative for aiding understanding of COVID-19
Parexel (MA, USA) has announced the addition of APANDEMIC and Datavant (CA, USA) as new partners in its #KeepingPatientsFirst initiative – an integrated, patient-centric research platform for collating and analyzing real-world data on COVID-19 impacts, disease trajectory, patient outcomes and potential treatments. Leveraging both Datavant’s secure data-linking capabilities and the expertise of the APANDEMIC leaders, Parexel hopes to advance the platform and accelerate healthcare providers’ access to these critical real-time data.
Thomas Bock, Co-Founder of APANDEMIC, explained: “As leaders in healthcare and technology, we have a responsibility to patients and healthcare workers to offer our expertise and services to help solve the COVID-19 pandemic. #KeepingPatientsFirst is a unique opportunity in that this platform is focused on providing real-time information to help patients today and in the future.”
The National Evaluation System for Health Technology Coordinating Center (NESTcc; VA, USA) has announced its launch of NEST 1.0, opening itself up to the conduct of sponsored-funded research to advance the generation and use of high-quality, reliable and relevant real-world data in evaluations of medical devices. The development follows both the conduct of US FDA-funded test-case projects led by NESTcc – to provide proof of concept for generating high-quality real-world evidence for medical devices across their lifecycles – and the organizations publication of data quality and methods frameworks outlining principles for generating high-quality real-world evidence studies for medical devices.
Jeff Shuren, Director of the US FDA’s Center for Devices and Radiological Health, commented: “NEST will advance the creation of a true learning system that allows for the ongoing evaluation of technology across the total product life cycle. As we move to a digitized world for device evaluation and surveillance, NEST can serve as a vehicle to drive evidence generation and enable new models of oversight to better meet the needs of patients.”
The US FDA has announced its pilot launch of a ‘first-of-its-kind’, online platform – Project Patient Voice – to communicate and share patient-reported outcome and symptom data from cancer clinical trials of marketed therapeutics with the public.
Amy Abernethy, Principal Deputy Commissioner at the FDA, explained: “Project Patient Voice has been initiated…to give patients and health care professionals unique information on symptomatic side effects to better inform their treatment choices. The…pilot is a significant step in advancing a patient-centered approach to oncology drug development.”