In 2016, the 21st Century Cures Act was signed into law, mandating that the FDA “establish a program to evaluate the use of real-world evidence (RWE) to help support the approval of new indications for a drug and to help to support or satisfy post-approval study requirements.” Along with advances in the availability and quality of real-world data (RWD) from sources like electronic health records (EHRs), registries, medical claims and pharmacy data, the Cures Act has been a catalyst for increased
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Life Sciences | News, Analysis, Insights - HIT Consultant
Medidata, Labcorp Partner to Expand Decentralized Clinical Trials for Digital Biomarker Discovery
What You Should Know: - Medidata, a Dassault Systèmes company, today announced a first-of-its-kind partnership with Labcorp using the Medidata Sensor Cloud to introduce a new model to advance the use of medical-grade sensors in clinical trials and accelerate biomarker discovery. - As part of the partnership, Medidata will receive and process medical-grade sensor data within drug, vaccine and device trials across Labcorp Drug Development’s clinical trial portfolio,
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EHR Data Reveals COVID-19 Vaccines Effective in Preventing Hospitalizations, ER Visits
What You Should Know: - Real world evidence from electronic medical records (EHR) data reveals the COVID-19 vaccines are highly effective at preventing hospitalizations, emergency department visits and intensive care admissions due to the virus, according to a study just published in the New England Journal of Medicine (NEJM). - The study, “Effectiveness of COVID-19 Vaccines in Preventing Ambulatory and Inpatient Care” analyzes actual data from hospitals around the US and shows
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Cedars-Sinai Cancer Launches ‘Molecular Twin’ Initiative for Precision Cancer Treatment
What You Should Know: - Cedars-Sinai Cancer and Tempus, a provider of artificial intelligence and precision medicine, are harnessing the power of big data and AI to design personalized cancer treatment options by creating virtual replicas of patients' DNA, RNA, protein and other information to help identify the most effective approach to each individual's disease. - By creating these "molecular twins," scientists can genetically classify cancer genes and proteins of particular tumors
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H1 Launches Solution to Build More Inclusive, Successful Clinical Trials
What You Should Know: - H1, which provides the largest global healthcare platform connecting the healthcare ecosystem, announced today that it has launched H1 Trial Landscape, the first solution that not only helps pharma and life sciences companies determine the required clinical experience levels for their clinical trials, but also enables them to find the best patient segments to improve inclusivity, retention and recruitment for successful trials. - Studies have shown that more than
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Clinical Trials: 4 Strategies to Maximize Patients Referrals
Clinical trials were front and center in 2020, as pharma companies raced to develop and prove the safety and efficacy of their COVID-19 vaccines. Despite this increased awareness, many potential participants and referring clinicians remain unaware of available trials and how to become involved. This negatively impacts enrollment efficiency and overall study timelines. Enter patient referral platforms. The growth of these third-party services has helped bridge the knowledge gap for both
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Fresenius Medical Invests Additional $25M in Biotech Platform Humacyte
What You Should Know: Fresenius Medical Care (FMC) today announced its plans to invest an additional $25 million in clinical-stage biotechnology platform company Humacyte following the extension of its collaboration in June. Fresenius Medical Care acquired a stake in Humacyte in 2018 for $150M as part of a strategic partnership. Following the merger of Humacyte with a special purpose acquisition company (SPAC), FMC is increasing its position in the newly combined
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Ontada, Merck Partner to Facilitate Real World Evidence Studies for Cancer Care
What You Should Know: - Ontada, McKesson’s oncology and insights business, announced a strategic agreement with Merck, known as MSD outside the United States and Canada, that will facilitate the development of real-world research excellence and innovation. This agreement enables the two healthcare leaders to harness the power of real-world evidence (RWE) towards the common goal of improving patient outcomes and the quality of cancer care. - Ontada and Merck’s combined experience and
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Why We Need a Personalized Approach to COVID-19 Immunity Testing
To date, the battle against COVID-19 has been waged largely in the field of public health, using a series of binary, black-and-white thresholds to measure progress. The number of positive cases per 100,000 people, yes/no results on PCR tests, absence or presence of antibodies – these have set the benchmarks used to determine when we can open our schools and restaurants, remove our masks and resume something resembling our old routines. While these numbers do tell us something about the
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Curebase, AppliedVR Partner on Multiple VR Therapy Clinical Trials
What You Should Know: - Curebase, a company committed to democratizing access to clinical studies, and AppliedVR, a pioneer advancing the next generation of digital medicine, today announced a one-year partnership where AppliedVR will deploy the Curebase platform to run five clinical trials assessing the effectiveness of virtual reality-based (VR) therapy to treat chronic pain. - AppliedVR is the most evidence-based therapeutic VR platform for pain management and has been used by
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