Biomarkers, electronic health records (EHR), genomic data, imaging data, labs, social media, wearable sensors, and more provide enormous new sources of RWD that can aid in new discoveries for the quality, efficacy, and safety of new drug therapies.
Regulators and experts consider patient-reported outcomes (PROs) as the gold standard when assessing a patient’s subjective treatment experience. As such, ePROs can be the key to product differentiation for sponsors seeking to highlight their product’s ease of administration, tolerability, or compatibility in combination with other components of a treatment regimen.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
OneOncology recently announced that it is deploying Verily’s clinical trial management platform across 11 of its community oncology clinics. Adopting Verily’s software will hopefully make clinical trial management much easier for OneOncology, which would allow the company to further democratize trials to improve health equity, the company’s chief medical officer said.
Paradigm, a new startup co-incubated by ARCH Venture Partners and General Catalyst, recently launched with $203 million in Series A funding. The company is focused on improving equitable access to trials by creating a less fragmented and more efficient clinical research ecosystem.
Clinical trials are the safest and most trusted route for identifying new breast cancer treatments, and the more research that can be done, the closer we will be to eradicating breast cancer for good.