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RWE

Housing Instability Worsens Health Outcomes

March 17th, 2023|Categories: Featured, Industry News|Tags: , , , , |

Astronomical rent and home prices are driving the ever-worsening affordable housing crisis. A newly published article in JAMA Network Open explores the link between housing instability and health outcomes, finding that displacement and unsafe living situations related to unaffordable housing are tied to worse mental and physical wellbeing.

Teppeza Improves Vision for Patients with Thyroid Eye Disease in Real-World Data Study

March 16th, 2023|Categories: Featured, Industry News|Tags: , |

Results from a real-world data analysis show that Horizon Therapeutics’ Teppeza improves vision for patients with dysthyroid optic neuropathy (DON), a progressive eye disease related to thyroid dysfunction. Blindness is a leading fear of patients with the disease, making the therapy a promising prospect for many high-risk individuals.

Talking Real-World Evidence and Individualized NSCLC Therapy with Daryl Pritchard

March 16th, 2023|Categories: Featured, Industry News|Tags: , , |

Precision therapy for non-small cell lung cancer (NSCLC) could save patients’ lives, but access to these treatments and the required genomic and biomarker testing are out of reach for many. In a new OncLive interview, Ashling Wahner talks about recently presented research into the impact of targeted therapy, or the lack thereof, with the VP of Science Policy at the Personalized Medicine Coalition Daryl Pritchard, PhD.

Modern Drug Development Depends on RWD

March 14th, 2023|Categories: Featured, Industry News|Tags: , |

Drug developers and other life sciences organizations now have access to troves of real-world data (RWD) that can accelerate research and market access efforts. RWD and the real-world evidence generated let researchers study the effects of drugs in real-world conditions and make comparisons that may not be feasible in traditional clinical trial formats.

Leveraging Real-World Data in Research and FDA Approval Applications

March 10th, 2023|Categories: Featured, Industry News|Tags: , |

The US Food and Drug Administration (FDA) has increasingly encouraged drug developers to use real-world data (RWD) and the real-world evidence (RWE) generated from it in applications. As a result, more and more companies are using RWD and RWE in novel clinical trial designs, applications to extend indications, and in post-approval studies.

Merck Announces Foundry DevTools Data Library is Now Free on Github

March 8th, 2023|Categories: Featured, Industry News|Tags: , , , , |

Merck KGaA has announced that its Foundry DevTools library, created with Palantir Technologies, will be freely available to users on Github, an open-source repository of code and software development resources. Merck and other pharma giants have used the platform for drug development and real-world evidence (RWE) analysis. This move marks a first for the platform.

Real-World Data Study Identifies Negative Health Outcomes in Long COVID Patients One Year Out

March 6th, 2023|Categories: Featured, Industry News|Tags: , , , , |

A newly published study in JAMA Health Outcomes found several adverse health outcomes in people living with long COVID one year after their initial infection. The researchers analyzed data from 13,435 people with long COVID symptoms and nearly 27,000 without it, finding that those with long COVID had increased care utilization and higher rates of a litany of cardiovascular symptoms.

HealthCore Changes Name to Carelon Research

March 1st, 2023|Categories: Featured, HEOR Feature, Industry News|Tags: , |

The healthcare data company HealthCore announced today, March 1st, that it has undergone a name change. The company, now dubbed Carelon Research, will continue its dedication to providing its healthcare data and evidence generation services to its clients across industry, academia, and other life science stakeholders. The change marks the company’s entrance into the broader Carelon family.

Value in Health Review: Applying Machine Learning to Wearable Data to Generate HEOR Insights

February 27th, 2023|Categories: Featured, Industry News|Tags: , , , |

An article in the latest issue of Value in Health breaks down how machine learning can be applied to data from wearable devices to advance health economics and outcomes research (HEOR). Wearables are a font of real-world data (RWD) that can be analyzed by machine learning (ML). By addressing existing issues of data quality and effective usage, such a trove of information could accelerate research and decision-making process for payers, regulatory bodies, and pharma companies.

Advancing Rare Disease Drugs Through Real-World Evidence

February 27th, 2023|Categories: Featured, Industry News|Tags: , , , , |

Patients with rare diseases often suffer with few effective treatment options. Therapeutic development for these drugs targeting rare diseases increasingly depends on real-world evidence (RWE). In a new IQVIA blog, learn more about efforts in the UK to advance the development of drugs for rare diseases through the careful use of RWE.

CDC Launches Initiative to Accelerate Health Data Modernization Efforts

February 27th, 2023|Categories: Featured, HEOR Feature, Industry News|Tags: , , , |

The US Centers for Disease Control and Prevention (CDC) has announced a new initiative to modernize its public health data infrastructure. The Initiative, announced today, February 27th, will be a cooperative public-private effort led by the agency, the National Coordinator for Health Information Technology (ONC), and the CDC Foundation, an independent non-profit started by Congress.

NIH Funds Project to Use Digital Twins to Advance Health Equity

February 22nd, 2023|Categories: Featured, Industry News|Tags: , |

A group of researchers at the Cleveland Clinic have been awarded a grant from the US National Institutes of Health totaling $3.14 million. The project will look at advancing health equity efforts using digital twins, simulated patients built from pools of real-world data (RWD) whose details, like social determinants of health (SDoH) mirror participants in trials.

Real World Data Study Breaks Down Data Quality Assessment for COVID-19 Therapeutics

February 20th, 2023|Categories: Featured, Industry News|Tags: , |

There is a significant pool of electronic health records (EHR) that could be used to generate real-world evidence (RWE) exploring COVID-19 therapeutics, but data quality and interoperability varies between sources. A newly published study in BMC Medical Research Methodology examines data assessments for COVID-19 therapeutic real-world data (RWD) sources.

FDA Opens Public Comments for Draft Guidance on External Controls in Clinical Trials

February 8th, 2023|Categories: Featured, HEOR Feature, Industry News|Tags: , |

The US Food and Drug Administration (FDA) is seeking comments for its newly released draft guidance on using external controls in clinical trials, a move that comes as the agency is increasingly relying on real-world evidence (RWE) for regulatory decision-making. Comments must be submitted by May 2nd, 2023 to be considered during the development of the final guidance.

Real-World Data Study Backs Up Ide-cel CAR-T Therapy for Multiple Myeloma

February 6th, 2023|Categories: Featured, Industry News|Tags: , |

A real-world data (RWD) study published in the Journal of Clinical Oncology found Celgene’s Abecma (ide-cel) CAR-T therapy was both safe and effective in the treatment of multiple myeloma. The data, taken from 196 patients, further back up the results from the Phase II KarMMa trial that helped support the approval of the therapy back in 2021.

Better Real-World Data Through the Cloud

February 6th, 2023|Categories: Featured, Industry News|Tags: , |

Real-world data (RWD) and the real-world evidence (RWE) generated from it are increasingly used in clinical trials and healthcare decision-making. However, the utility of real-world datasets are held back by issues of data quality and interoperability. In a new Health Tech Magazine article, learn about how cloud computing can help improve RWD sources and advance clinical trials and more.

US FDA Unveils New Draft Guidance for Using External Control Arms

February 2nd, 2023|Categories: Featured, Industry News|Tags: , |

The US Food and Drug Administration (FDA) has issued a new draft guidance regarding the use of external control arms in clinical trials. The guidance comes as external controls are increasingly implemented in trials, owing to the growing acceptance or real-world evidence (RWE) in regulatory decision-making. This is especially the case in trials diseases that have small populations or those where holding back treatment would be potentially unethical.

Examining the Impact of Real-World Evidence in EMA Regulatory Decisions

February 1st, 2023|Categories: Featured, Industry News|Tags: , |

Real-world data (RWD) and the real-world evidence (RWE) generated from it are increasingly used in health technology assessment (HTA) decisions from regulatory bodies worldwide, including the European Medicines Agency (EMA). In an open-access article published in Clinical Pharmacology  & Therapeutics, learn more about how the EMA uses RWE in its decision-making.

Veradigm Network EHR Data Now Available in OMOP CDM Data Standard

January 31st, 2023|Categories: Featured, Industry News|Tags: , |

Veradigm Network, a major health IT company previously named Allscripts, has announced that its stores of electronic health record (EHR) data will be accessible in the Observational Medical Outcomes Partnership (OMOP) Common Data Model (CDM) data standard. This will make it easy for clients to generate and use real-world evidence (RWE) from over 170 million patients.

Talking Real-World Evidence with Healthcore’s Co-Founders Mark Cziraky and Marcus Wilson

January 26th, 2023|Categories: Featured, Industry News|Tags: , |

As Healthcore gears up for their impending brand transition to Carelon Research in the coming months, co-founders Mark Cziraky and Marcus Wilson discussed their insights into the importance of high-quality real-world evidence (RWE) generation methods and why they founded the company. The two worked together as pharmacists before starting Healthcore back in 1996.

New Venture Capital Firm Launches to Support Health Sciences Digitization

January 25th, 2023|Categories: Featured, Industry News|Tags: , |

Cutting edge technology like big data analytics, artificial intelligence, and machine learning are poised to revolutionize life sciences and healthcare. Dimension, a new venture capital fund, has launched today in to support the digitization of life sciences. The fund is prepared to support new startups with a war chest of $350 million.

Target RWE Releases 35 Disease Real-World Evidence Registries

January 25th, 2023|Categories: Featured, Industry News|Tags: , |

Earlier this month, Target RWE announced the release of 35 observational disease state real-world evidence (RWE) registries. The disease fields covered by the registries include autoimmune disorders, neurological conditions, metabolic diseases, and more. The data will include patient reported outcome measures, clinical exam results, and tissue samples in a proprietary biobank.

Aetion Announces 5-Year Real-World Evidence Collab with FDA

January 25th, 2023|Categories: Featured, Industry News|Tags: , |

Aetion has announced a new partnership with the US Food and Drug Administration’s (FDA’s) Oncology Center of Excellence (OCE) to promote oncology care and prevention through its real-world evidence (RWE) offerings. As part of the 5-year collaboration, the OCE will have access to the company’s Evidence Platform. This move adds another team-up for Aetion.

Verana Health Publishes Real-World Data Ophthalmology Study Replicating Phase III Trials

January 19th, 2023|Categories: Featured, Industry News|Tags: , , , |

Verana Health has announced the publication of its research in Ophthalmic Surgery, Lasers and Imaging (OSLI) Retina. The study used de-identified real-world data (RWD) and replicated two phase III trials for the use of Regeneron in wet age-related macular degeneration, making it the first of its kind in the field.

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