Real World Evidence

Selected news for the healthcare topic - Real World Evidence, collected since 10/2017. This healthcare topic shares news with Quantzig, COVID-19, IQVIA, Food and Drug Administration and dozens of others.

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Date Headline (link) Source Relevant Snippet
12/13/2021 Self Care Catalysts' Patient Centered Platform Business Wire ... digital health company that puts patients at the center of human networks, science and technology launches its Health Storylines platform globally to help patients manage their individual health in a way that also generates real world evidence of the patient’s experience to facilitate the effective delivery of care and medicines. Example areas of application include COVID Vaccine safety studies, Oncology, Medical Diagnostics, Rare Diseases and more. The platform is ...
12/3/2021 Sobi shares fall as $8B bid for company withdrawn | 2021-12-03 | BioWorld BioWorld ... announced, to yesterday’s high of 11,535 [PCR confirmed infections],” said health minister Joseph Phaahla, in a briefing on Dec. 3. At the same time, scientists in South Africa published a preprint detailing real world evidence of an increased risk of SARS-CoV-2 reinfection associated with the emergence of Omicron.Ardelyx going solo with IBS-C therapy Ibsrela, marketing to start next year Having made known its hopes ...
10/19/2021 Real World Evidence (RWE) Drug Development: A Faster/Cheaper Route For Psychedelics marijuanastock.net Real World Evidence (RWE) Drug Development: A Faster/Cheaper Route For Psychedelics [Feature Article] / 19 Oct 2021 Real World Evidence (RWE) Drug Development: A Faster/Cheaper Route For Psychedelics - Formal drug development through clinical trials is a long and expensive process - As the Mental Health Crisis spirals out of control, people need access to psychedelic-based next-generation mental health therapies today - How RWE drug development can accelerate the Psychedelics ...
10/19/2021 Data Expert Discusses 9 RWE Applications in Healthcare and Pharma R healtheconomics.com Vice President of Business Development & Real World Evidence (RWE) at ArborMetrix Benjamin Echeazu discusses the growing use of RWE in a wide range of applications—from drug development to tangibly improving patient outcomes. He details nine use cases where RWE and real world data (RWD) informed decision-making. According to Echeazu, “Unlike traditional clinical trials, where necessary data elements can be curated and collection mandated, the creation of RWE requires ...
10/19/2021 Using Real World Data to Examine Long-Term Safety and Effectiveness in Extension Studies pharmexec.com ... that leverage RWD and/or direct to patient follow-up, it is possible to measure outcomes with less burden on investigators and sites.\n\nDesigning fit-for-purpose studies\n\nThe key to generating real world evidence (RWE) on long-term safety and effectiveness in extension studies is to ensure that critical information from the parent study is captured and integrated with the study data for the extension study and ...
10/13/2021 The Evolution of Site Selection appliedclinicaltrialsonline.com ... trials, when pharma said we have no choice but to adopt in situ–or both reasons–the clinical trial industry is doing a 180, site-selection speaking.\n\nIn situ is in; it guarantees real world evidence because in situ naturally leads to where patients live, are treated, and immortalized, to whatever extent, via their health system’s EHR and other data sources.\n\nWhat’s remarkable here is how ...
10/13/2021 mcare joins fellow home health leaders to discuss the future of care | Financial Buzz financialbuzz.com ... health technology modernization symposium focusing on health policy, telehealth, blockchain and artificial intelligence and connectivity in a refocused healthcare market. It is the premier destination community identifying new and cost-effective paths forward through real world evidence , strategy, operations, research & trends, where healthcare leadership and breakthrough technology providers inspire and guide informed decision making for niche markets in the exploding digital health marketplace.“We are continually seeing the conversation become ...
10/13/2021 Ōmcare joins fellow home health leaders to discuss the future of care Yahoo News ... health technology modernization symposium focusing on health policy, telehealth, blockchain and artificial intelligence and connectivity in a refocused healthcare market. It is the premier destination community identifying new and cost-effective paths forward through real world evidence , strategy, operations, research & trends, where healthcare leadership and breakthrough technology providers inspire and guide informed decision making for niche markets in the exploding digital health marketplace."We are continually seeing the conversation become ...
10/13/2021 Ōmcare Joins Fellow Home Health Leaders to Discuss the Future of Care medicalalley.org ... health technology modernization symposium focusing on health policy, telehealth, blockchain and artificial intelligence and connectivity in a refocused healthcare market. It is the premier destination community identifying new and cost-effective paths forward through real world evidence , strategy, operations, research & trends, where healthcare leadership and breakthrough technology providers inspire and guide informed decision making for niche markets in the exploding digital health marketplace. “We are continually seeing the conversation become ...
10/13/2021 ICER Meets With FDA, EMA, and FDA to Discuss RWE Procedures healtheconomics.com In a recent meeting, members of the Institute for Clinical and Economic Review (ICER), the Food and Drug Administration (FDA), and the European Medicines Agency (EMA) discussed how to address real world evidence (RWE) studies. ICER discussed its recent RWE framework and its interest in incorporating RWE studies into its value assessments by partnering with Aetion. ICER also discussed results from its RWE study on hereditary angioedema treatments . Aetion CEO ...
10/13/2021 In review, FDA stays neutral on the need for a Moderna booster Star Tribune The Food and Drug Administration set the stage Tuesday for a new round of decisions on which Americans should get coronavirus booster shots, releasing a review of data suggesting that an additional half-dose of Moderna's vaccine at least six months after the second dose increased antibody levels. But the agency did not take a position on whether an additional shot was necessary. An independent advisory panel of experts will ...
10/12/2021 ISPOR 2022 Meeting Seeking Abstracts on RWE and HEOR healtheconomics.com The International Society for Pharmacoeconomics and Outcomes (ISPOR) is seeking abstracts for its 2022 meeting, held both in-person and virtually next May. Major trends that will be discussed include the state of health economics and outcomes research (HEOR) and real world evidence (RWE) studies. “Prime components of the ISPOR 2022 program are the issue panel, workshop, and other breakout sessions. Issue panels introduce debates with multistakeholder perspectives on new ...
10/9/2021 SAGE models need a reality check alethonews.com ... poorly understood. However, the models used by SAGE to justify draconian restrictions are far too simplistic – they are based on a handful of assumptions that have not been adjusted in the light of real world evidence , despite numerous forecasting failures. First, they assume that every individual is equally susceptible to every variant. SAGE therefore assumes that each outbreak will lead to uncontrolled, exponential viral spread unless there is a ...
10/8/2021 Syapse Announces RWD Partnership with Merck to Accelerate Oncology Research and Improve Patient Outcomes healtheconomics.com Real world evidence (RWE) leader Syapse has announced a partnership with Merck. Together, the companies will utilize real world data (RWD) to understand the outcomes of patients living with cancer and improve care. The companies will leverage clinical, outcomes, and molecular data using the Syapse Learning Health Network. Syapse CEO Ken Tarkoff remarks, “We’re very proud to be partnering with Merck’s CORE team on such a large, important ...
10/8/2021 Part 2 of Aetion's ICPE Research Spotlight Highlights RWD in COVID-19 Research and Updated RWE Guidance healtheconomics.com ... All Access Meeting hosted by the International Society for Pharmacology (ISPE) include successfully using fit-for-purpose real world data (RWD) to understand the impact of COVID-19. Other major topics included comparisons between real world evidence (RWE) frameworks, managing channeling bias, and leveraging claims data. “At ICPE All Access 2021, Aetion scientists and their collaborators presented learnings from continued efforts to advocate for best practices in pharmacoepidemiologic methods.” ...
10/8/2021 Aetion eBook Highlights the Impact of RWE in Successful Drug Approvals Ahead of FDA Framework healtheconomics.com Aetion has published an eBook detailing how real world data (RWD) and real world evidence (RWE) can impact drug approvals by the Food and Drug Administration (FDA). The eBook includes case studies where RWE led to the approval of drugs and biologics. The guide also compares RWE use in 10 areas of study, including oncology and neuroscience drug approvals. “Aetion’s comprehensive eBook—updated for 2021 with new data and ...
10/7/2021 BioNTech SE [BNTX] stock Upgrade by Bryan Garnier analyst, price target now $451 dbtnews.com ... variation regarding a booster dose, the decision will be immediately applicable to all 27 EU member states. The positive opinion by the CHMP is based on the clinical trial data shared by the companies, real world evidence as well as literature data. The data submitted by BioNTech and Pfizer include data from their clinical program evaluating the safety, tolerability and immunogenicity of a booster dose of COMIRNATY®. A booster ...
10/5/2021 EMA Data Expert Discusses Gaps in RWE Framework healtheconomics.com The European Medicines Agency (EMA) has recognized gaps in guidelines on real world evidence (RWE) submissions. The EMA’s Xavier Kurz recently spoke at Regulatory Affairs Professionals Society (RAPS) Convergence 2021 regarding the importance of RWE and the need for updated submission instructions. Kurz asked, “What is the purpose of real-world evidence? How is it presented? What is the information that is needed? There is a need for perhaps ...
10/5/2021 Specialty focused tech businesses to see strong traction indiatimes.com Specialty focused tech businesses to see strong traction Specialty focused tech businesses to see strong traction; led by an ability to focus on longitudinal patient journeys, resulting in better patient experience and valuable real world evidence (RWE) for pharma companies ...
10/4/2021 Pfizer and BioNTech Receive CHMP Positive Opinion for COVID-19 Vaccine Booster in the European Union Globe Newswire ... variation regarding a booster dose, the decision will be immediately applicable to all 27 EU member states. The positive opinion by the CHMP is based on the clinical trial data shared by the companies, real world evidence as well as literature data. The data submitted by BioNTech and Pfizer include data from their clinical program evaluating the safety, tolerability and immunogenicity of a booster dose of COMIRNATY®. A booster ...