A new study this month has added to the so-far scant data available on the ability of Guardant Health’s Guardant360 assay to predict responsiveness to immunotherapy using a blood-based signal to infer how highly mutated a patient’s cancer is. Published in Nature Medicine on July 15, the study focused on a group of 61…
Medical experts are turning to EHR data, coupled with billing records, to help refine treatments and find new uses for drugs that have already been approved, according to NPR. Here are five things to know: The FDA has authority over drug approvals. However, when it comes to a newly approved drug, physicians don’t always…
When we go to the doctor. Then the doctors administer the problem and try to reach the possible best treatment possible for a certain problem. Sometimes you will feel that the doctor is spending more time to know and collect the data about you rather than giving you some prescriptions. Electronic medical records are available…
When you go to your doctor’s office, sometimes it seems the caregivers spend more time gathering data about you than treating you as a patient. Electronic medical records are everywhere – annoying to doctors and intrusive to patients. But now researchers are looking to see if they can plow through the vast amount…
A recent study has quantified the wide disparity between the FDA-approved labelling of prescription drugs and real-world clinical practice. When new prescription drugs are approved for marketing in the United States, the Food and Drug Administration (FDA) provides the accompanying drug-related information. Once the drug is in use in the population, clinicians and researchers observe…
The Food and Drug Administration might one day use data gathered from off-label uses of drugs to determine whether or not to approve the drugs for those uses, an agency division director said Tuesday. The FDA approves drugs for specific conditions in certain groups of people and then spells out those prescribed uses on…
A pilot study released Tuesday supports the use of real-world evidence (RWE) to understand mortality data while highlighting the barriers to using such data in regulatory decision-making. The retrospective observational analysis was the result of a pilot project aimed at determining whether RWE can provide early insights into patient outcomes through the use of electronic…
Friends of Cancer Research released data Tuesday that support the use of real-world evidence (RWE) outcomes — including real-world progression-free survival (rwPFS) — as surrogate endpoints for overall survival to evaluate a treatment’s long-term effects. In the pilot program, a working group led by the non-profit Friends evaluated electronic health records (EHR) and claims…
Duane Schulthess of Vital Transformation sits down at the DIA Global conference in Boston, for a one on one discussion with Jeff Allen, CEO of Friends of Cancer Research from Washington DC. Washington DC’s Friends of Cancer Research is an advocacy group that has had a profound influence on how we bring new cancer therapies…
Executive Summary FOCR study suggests overall survival for PD-1s seen in real-world datasets is similar to results from clinical trials. BOSTON – Results of an upcoming study on the correlation of real-world endpoints to overall survival in trials could encourage sponsors to adopt broader inclusion criteria in clinical studies, according to Friends of Cancer…
