RWE

At this years’ Innovations in Regulatory Science Summit, hosted by the UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (CERSI), speakers talked about the hurdles faced in expanding the use of real-world evidence (RWE) and real-world data (RWD). Jeff Shuren of the FDA noted that collecting clinical evidence that meets regulatory standards will require a concerted effort by his and other federal agencies

Poor recruitment is the most cited reason that clinical trials fail. However, many healthcare giants are gathering sources of real-world data (RWD) like electronic health records (EHR) that can yield deep insights into patient recruitment strategies if used correctly. In particular, RWD from patients can help narrow down the recruitment focus to patients who are most likely to qualify.

Real-world data (RWD) and the real-world evidence (RWE) generated from it are increasingly being used by biopharma companies for a range of applications. However, the quality of RWD is inconsistent, potentially limiting its utility. In a new Clinical Leader article, RWD experts from Merck lay out best practices when evaluating RWD sources for relevance and quality.

With the recent rise of real-world evidence (RWE) and non-traditional clinical trial formats in regulatory and market access decision-making, developing effective integrated evidence generation strategies has become a priority for all stakeholders in therapeutic development. The complexities of the modern evidence generation process are laid out in a recent Pharmaphorum article by experts from Fishawack Health.

On the latest episode of the pharmaphorum podcast, listen to back-to-back interviews at last month’s PharmStars presentation. Host Jonah Comstock talks with speakers and guests about the current use of real-world data (RWD) and real-world evidence (RWE) in clinical trials and how different startups have managed these challenges.

Newly-reported real-world evidence (RWE) from Servier shows that adults and adolescents taking asparaginase-based pediatric inspired regimens (PIR) have better outcomes with acute lymphoblastic leukemia than those on non-pediatric treatment plans. The retrospective data, presented at this years American Society of Hematology meeting, comes from claims data of 11,650 patients.

OMNY Health has announced it has been awarded $17 million in a Series B funding round. The company, which equips provider organizations and other healthcare stakeholders with real-world data (RWD) and real-world evidence (RWE), will use the funding to help support the company’s continued growth and RWD/RWE offerings.

Biopharma companies have turned to real-world evidence (RWE) and the real-world data (RWD) it is generated from to support clinical trials and market access efforts, especially as health technology assessment (HTA) bodies increasingly encourage its use in regulatory decision-making. In a recent article in Deloitte, industry leaders discuss how RWE use has extended enterprise-wide and across all stages of  drug life-cycles.

Newly presented data at a special conference of the American Association for Cancer Research shows that Lucid Diagnostics’ EsoCheck medical device is well tolerated when used in the early detection of esophageal precancer. The study used data taken from 687 patients, finding that 98% of patients completed the procedure. Moreover, DNA was successfully extracted from 90% of patients.

Lunit has extended its artificial intelligence (AI) efforts into the field of breast cancer, releasing real-world data (RWD) demonstrating promising results. Researchers used the AI to identify cancer from mammograms, beating a team of two radiologists in diagnostic accuracy. The data comes from a pool of nearly 56,000 patient mammograms. The research will be presented in several forms at the upcoming RSNA Annual Meeting.

Lumanity has announced a new partnership with HealthVerity. As part of the partnership, the two companies will work together to advance research by combining the deep real-world data (RWD) and real-world evidence (RWE) offerings of Lumanity and HealthVerity’s IPGE platform, a massive interoperable RWD platform. IPGE contains RWD from claims data, pharmacy data, & lab data.

Getting enough patients with the right characteristics for control arms in clinical trials is difficult and can be fraught with ethical concerns. A startup called Unlearn.ai hopes to address this issue using digital twins, simulated patients for control arms that are generated using real-world data (RWD) and artificial intelligence (AI).