The Disconnect Between Clinical Trial and Real-World Populations Holds Back Oncology Care
Randomized controlled trials (RCTs) are the gold standard for regulatory approval. However, cancer trial participants are often not representative of real-world patient populations. As a result, patient outcomes may not mirror those found in trials. In a new article published on OncLive, Maurie Markman, MD, discusses the shortcomings of traditional RCTs and how unrepresentative patient populations hold back therapeutic development.
Researchers Put Forward New Healthcare Data Use Framework
A group of researchers from around the world have proposed a new framework for the use of healthcare data in research. The framework, published in several journals, guides researchers in several aspects of healthcare usage, such as transparency, quality assessment, and more. The team constructing the framework consisted of stakeholders from healthcare, government, research, and patient advocacy groups
Novartis Leans into US Market, Drug Pricing Reform Notwithstanding
Novartis investors were told that the pharma giant would laser focus on the US market in an event on Thursday, September 22nd. The announcement comes weeks after the US government passed drug pricing reform which critics argued would stifle innovation and investments in the nation. This push would help expand the company’s patient recruitment efforts and invest in its US personnel.
Cleveland Clinic Awarded $7.4 for Research into Improving Outcomes for Older Patients After Hospitalization
Many older patients experience a litany of negative health outcomes following a hospital stay, often leading to compounding complications. The US National Institute of Aging (NIA) has awarded the Cleveland Clinic $7.4 million for a project designed to study ways to improve health outcomes for seniors after a hospital stay. Since bed rest is associated with worsened outcomes, one avenue of exploration includes hospital mobility programs, which try to get patients moving daily.
FDA and NIH Announce Collaboration With C-Path to Advance Treatment of Rare Neurodegenerative Conditions
The US Food and Drug Administration (FDA) and the National Institute of Health (NIH) have announced they are partnering with the Critical Path Institute (C-Path) to promote research into rare neurodegenerative conditions. The agencies will work with the non-profit organization to advance individualized therapeutic development and collect a central repository of research and patient data for rare neurological disorders.
Webinar: Making HEOR More Accessible to Patients – October 13th
Health economics and outcomes research (HEOR) is increasingly being picked up by providers, payers, drugmakers, and regulatory decision-makers for its value in healthcare and research. Patients and patient advocacy groups, however, may be intimidated by the jargon and acronyms of the field. In an upcoming webinar on October 13th, HEOR experts will discuss how to make HEOR relevant and accessible for patients and why it’s important.
Webinar: Avoid The Valley of Death – Increase Confidence in Translational Research Using Biosimulation – September 12th
Only a third of preclinical programs make it to Phase 1 trials. Honing translational research is key to reducing the substantial financial risk associated with drug development. A new tool to help narrow the focus of preclinical programs is physiologically-based pharmacokinetic modeling (PBPK) modeling and simulation. Correct implementation can help predict human doses, find prime targets, and identify interactions.
Using Real-World Data to Boost Clinical Trial Patient Diversity
The patient population of clinical trials currently and historically have rarely represented the demographics of the general population. Real-world data (RWD) is increasingly being used to help address these disparities in trial participation. RWD sources are often far more diverse than patient pools available for physical clinical trial sites due to geographical and economic constraints.
Webinar: Overcoming Patient Recruitment Challenges in Rare Disease Trials
Nearly 450 million people live with rare diseases globally. This diverse population needs treatment options, but clinical trials are made [...]
Genesis Research Partners With Syapse to Provide Oncology RWE
Genesis Research is forging a new partnership with the real-world evidence (RWE) company Syapse. The two companies will combine their RWE offerings to oncology research experts. As a result, firms working with Genesis Research and Syapse will have access to a vast repository of oncology real-world data (RWD) and top-of-the-line analytical tools to accelerate clinical development and market access.
Health Affairs Offers Health Equity Fellowship for Trainees
Health Affairs is offering a new fellowship to help promote racial equity in publishing in the health policy field. The Health Equity Fellowship for Trainees (HEFT) will pair fellows up with experienced mentors that are on the Health Affairs editorial staff or have published in the journal before. The goal is to help trainees prepare and enhance their manuscripts to have the best possible chances of being published in the journal.
Endpoints Webinars: How the Current Investment Landscape is Stifling Rare Disease Development – September 15th
Despite the pressing need for appropriate treatments, the investment landscape is not amenable to therapeutic development. In an Endpoints webinar hosted on September 15th, speakers will discuss the current state of rare disease drug development funding and how the industry can foster innovation in spite of these difficulties.
Webinar: Overcoming Patient Recruitment Challenges in Rare Disease Trials – September 28th
Patient recruitment is one of the most difficult parts of any clinical trial, but it’s even tougher when studying therapeutics for rare diseases. In an upcoming webinar taking place on September 28th, speakers will discuss the unique challenges of patient recruitment in the field, how to speed up patient recruitment for rare diseases, and the lived experience of someone living with a rare disease.
Whitepaper: Making APAC the Oncology Clinical Trial Destination
A new whitepaper from Premier Research makes the case that the Asia-Pacific (APAC) Region is the hot spot for oncology clinical trials. Currently, APAC stands as the region with the most ongoing oncology trials worldwide, with the number of active trials growing 138% over the last 10 years. In the whitepaper, the authors break down what factors are driving this growth and why clinical research organizations (CROs) should consider hosting their trials in the region. Chief among these reasons is the massive potential patient pool.
CDC Director Reveals Restructuring Plans
CDC Director Rochelle P. Walensky, MD, MPH, has announced that the agency will undergo restructuring changes that are, in part, due to the agency’s response to the COVID-19 pandemic. Under the changes, the director will be reported to directly the Division of Laboratory Sciences and the Office of Science to ensure accountability. In addition, the agency will form a new executive council and equity office.
Whitepaper: How to Model Scientific Data for Analysis in Drug Discovery
Data modeling is an important but frequently ignored step of drug discovery. In a new whitepaper, PerkinsElmer Informatics shows how Signals Inventa can help companies develop data models that facilitate robust data analysis. The platform can integrate and compare data from early chemical surveying to in vivo experiments.
UK Lord’s Committee Share Worries Over Nation’s Goal to Become ‘Science Superpower”
The UK Lord’s Committee has released a report that casts doubts over the UK government’s goal of ‘science and technology superpower’. Last year, the government released its 2021 Integrated Review of Security, Defence, Development and Foreign Policy report that solidified these ambitions. The statement from the Lord’s committee lays out areas of improvement and proposes an actionable means to tackle these issues.
Contract research organization Service Market Trends, Leading Key Players, Future Growth, Revenue, Demand Forecast, Applications 2021-2027
A comprehensive overview of the contract research organization services market is recently added by UnivDatos Market Insights to its humongous [...]
Patrice Matchaba of Novartis Speaks About Company’s Initiative for Inclusion and Diversity
Novartis recently stepped up its efforts toward diversity and inclusion by launching the Beacon of Hope program, an initiative that works to create fruitful partnerships with 26 historically Black colleges and universities (HBCU). Late last month, Ed Miseta, Chief Editor of Clinical leader, discussed the program with Patrice Matchaba, MD, Head of US Corporate Responsibility at Novartis, and President of the Novartis US Foundation.
US Department of Justice Opens Investigation into Cassava Alzheimer’s Drug Data Manipulation Controversy
Late last year, reports surfaced that Cassava Sciences had falsified trial data regarding its experimental drug for Alzheimer’s disease. Now, the US Department of Justice (DOJ) has launched a probe into the allegations, sending the company’s share prices down by 30%. The claims originated from two doctors, represented by the law firm Labaton Sucharow, who found irregularities in data coming from Hoau-yan Wang, an Associate Medical Professor at City University of New York, and Lindsay Burns, Cassava’s VP of neurosciences.
GSK Shifts Focus After Haleon Spinoff
With the spinoff of its consumer healthcare operations into the new company Haleon, GSK is turning its focus onto new [...]
Webinar – Pain R&D: Plenty of Pain to Go Around, But Who’s Making Gains?
Despite a growing need for safe, effective pain drugs, the drug development pipeline is sparsely populated. Recent setbacks like those facing Lilly and Pfizer’s anti-NGF drug have chilled the atmosphere for new lines of research. In an Endpoints webinar on August 11th, Lei Lei Wu of Endpoints will sit down with Jan Adams of Grünenthal to discuss the situation and how to improve access to patients.
World Orphan Drug Congress Europe 2022 – 14-17 November 2022
Taking place in Spain this year, the World Orphan Drug Congress, the leading conference for orphan drugs and rare diseases worldwide, takes place in Sitges, Spain, from 17-14 November. The conference will bring together professionals from healthcare, research, regulatory agencies, payer organizations, and other key decision-makers to one place to connect and share ideas.
Syndicated Report: Global Gene Therapy Market Projections 2022-2031
Despite the global pandemic, cancer was still the leading cause of death in 2020. This pressing therapeutic need underlies the growth projected by Kenneth Research in their new report entitled, “Global Gene Therapy Market.” The report predicts that the gene therapy market will earn around $6 billion USD from 2022-2031 with a CAGR of ~34%.
On-Demand Webinar: Accelerating Patient Recruitment Post-COVID-19
The COVID-19 pandemic changed the playing field of clinical trial patient recruitment permanently. As the clinical research industry moves towards [...]
