All parts of the product development cycle—clinical trial management, regulatory affairs, commercialization, and everywhere in between—have invested in technologies to support operational efficiencies and productivity gains. But there has always been a gap in these technologies: the inability to […]
Get Drugs & Devices to Market Faster
COVID-19 is impacting HTA priorities and processes
Navigating global market access requirements in a dynamic environment As the COVID-19 crisis unfolds, the pharmaceutical and medical device industries are responding with new products, processes and solutions in record time. Many health technology appraisal (HTA) boards are prioritising these […]
Leveraging Simulation to Patch a Clinical Trial Broken by COVID-19
The basic structure of a randomized comparative clinical trial is quite simple. A candidate population that meets the admissibility criteria is recruited. Each candidate who consents to participate is randomly allocated to an experimental treatment or to one or more “controls.” The participants are […]
A Systematic Approach to Assessing Real-World Research Questions Supported by Digital Enablement
Multiple strategies, each with their individual advantages and drawbacks, may be employed to answer a research question, but determining the optimal strategy – the one that will bring you to your answer in the most effective and efficient way possible – that is the true challenge in our industry. […]
Version 4.1 of the AMCP Format: Introducing a Trio of Dossiers to Support a Product Throughout its Lifecycle
On December 23, 2019, the Academy of Managed Care Pharmacy (AMCP) released Version 4.1 of the AMCP Format for Formulary Submissions. This new version of the AMCP Format describes three types of dossiers that manufacturers may choose to develop: Unapproved Product Dossiers, Approved Product Dossiers, […]
Patient Preference Studies in HTA Decision Making: A NICE to Have?
There has been a lot of recent discussion about the potential role of patient preference (PP) data in support of reimbursement decisions. In January 2020, the National Institute for Health and Care Excellence (NICE) published a paper that provided more detail on the use of patient preference data. […]
Trends in Medical Device Purchasing, Evaluation of Value, and Advice for Manufacturers
This interview was conducted by Ann Menzie, MS, Senior Director, Evidence Synthesis, Modeling & Communication, Evidera, in conjunction with ongoing efforts to provide relevant and up-to-date information to help our clients develop and execute their evidence generation and market access […]
Integrated Scientific Advice during the COVID-19 Pandemic
The process of seeking scientific advice from regulatory agencies and health technology assessment (HTA) bodies has expanded in recent years and more pharmaceutical companies are looking to take advantage of the opportunity. The most prolific providers of this scientific advice is the European […]
US FDA’s Emergency Use Authorization (EUA): Applicability for Marketed and/or Investigational Products for Treatment of COVID-19
The Emergency Use Authorization (EUA) is a statutory authority which allows the US Food and Drug Administration (FDA) to help strengthen the nation’s public health protections against chemical, biologic, radiological, or nuclear (CBRN) threats by facilitating the availability and use of medical […]
Surprises You Don’t Want When Adopting eCOAs for Use in Clinical Trials: Cautions for Decision Making and Planning
The surge in the digitalization of communications over the past ten years is not only shaping our day-to-day lives but is also seeping through to scientific methodology such as clinical outcome assessment (COA) data collection methods in clinical trial research. COA tools are used to measure […]
Digital Approaches in the Era of COVID-19: Interviews with Science 37 and Medable
Recently Mariah Baltezegar, MBA, Executive Director and Head of Peri- and Post-Approval Virtual Trials with Evidera, and Niklas Morton, MSc, Senior Vice President and Global Head of Digital Services with PPD, spoke with leaders of Science 37 and Medable, two companies Evidera and PPD partner with […]
Evidence Generation Using Innovative, Technology-Driven Data Collection
Electronic medical records (EMR) are now widely implemented in healthcare organizations, and health information exchange (HIE) technology has been widely used to link patient information across different electronic sources. This offers an opportunity to connect to and communicate with EMR systems to […]
Digital Therapeutics: Past Trends and Future Prospects
Digital therapeutics (DTx) are a digital health category defined by the Digital Therapeutics Alliance as products that "deliver evidence-based therapeutic interventions to patients that are driven by high quality software programs to prevent, manage, or treat a medical disorder or disease." DTx are […]
Leveraging Decentralized RWE Data Collection Strategies during the COVID-19 Pandemic and Beyond
The COVID-19 pandemic has washed over the world in waves and affected every aspect of life, including most obviously, healthcare. The impact is not only seen in relation to coronavirus patients and studies, but the ripple effect is also seen across all clinical and real-world studies. Several key […]
The Potential Impact of Pharmaceutical and Non-Pharmaceutical Interventions to Mitigate the COVID-19 Crisis in the United States: A Model-Based Analysis
In light of COVID-19 and the far-reaching impact it is having on our society, Xcenda developed an infectious disease model to analyze the potential impact of both non-pharmaceutical and pharmaceutical interventions on mitigating the effects of the current pandemic. In particular, this model provides […]
How to make quality metrics work for you
All practices know they should be focused on quality. But what is the best way to choose from a wide range of competing metrics and rest assured that your selections will drive better outcomes? Find four tips, in a simple infographic, to make sure your quality metrics are the right ones, deployed in […]
eBook: 2020-2030 | Reimagining Healthcare IT for the Next Decade
While issues with first-generation EHRs have been well documented since the passage of the HITECH Act in 2009, there are significant untapped opportunities to optimize the EHR and health IT to benefit the entire care delivery chain. In this eBook, PatientKeeper outlines a vision for the future of […]
ISPOR Value of Information Task Force Publishes Two New Good Practices Reports
Value in Health, the official journal of ISPOR—the professional society for health economics and outcomes research, announced today the publication of 2 Good Practices Reports that together describe the findings of the ISPOR Value of Information Analysis Emerging Good Practices Task Force. The […]
The Convergence of Data Analytics and Artificial Intelligence (AI) in Healthcare
New research from HIMSS Media shows how healthcare organizations are turning to AI to keep up with the growing complexities of healthcare. Key finding: 75% of industry leaders reported that AI/ML will be a greater focus next year, but only 40% rated their current predictive or prescriptive analytics […]
Artificial Intelligence and Machine Learning
The potential associated with artificial intelligence and machine learning in healthcare is piquing the interest — and sparking the imagination — of healthcare industry professionals. How The Power Of Ai/Ml Can: Build Data And Analytics Competency Predict Sepsis And Other Health Risks […]
Prescription Price Transparency And The Patient Experience
As stories about sticker shock and the cost of care dominate headlines and policy discussions, healthcare organizations are looking for cost-effective ways to improve patient outcomes and experience. Prescription price transparency tools hold particular promise. We already know that providers want […]
Developing medical communications specifically for nurses
75% of oncology nurses say the biggest barrier to accessing new oncology research and drugs is the time commitment. Oncology nurses play a central role in supporting patients and their families that extends beyond providing care and administering therapy. They are involved in making treatment […]
Protocol Design in Real-World Evidence: The Indispensable Link Between Strategic Need and Study Execution
The development of new medical treatments follows a well-known pathway from the assessment of safety to the evaluation of therapeutic efficacy, proceeding to pivotal trials to support market authorization decisions.1 Pivotal trials are most commonly designed as traditional randomized clinical […]
Health Economics in China: Changing Pharmaceutical Pricing and Reimbursement
Universal healthcare now covers 95% of the population in China and, given limited budgets, healthcare payers are struggling to fund both best medical practice and new innovative medicines. To manage their budgets more effectively, substantial changes have been introduced to the market access process […]
The Growing Influence of the Institute of Clinical and Economic Review on Payer Decisions in the US
Health technology assessment (HTA) bodies, like the National Institute for Health and Care Excellence (NICE) in the UK and the Canadian Agency for Drugs and Technologies in Health (CADTH) in Canada, have become increasingly important in countries across the world as arbiters who determine the […]
Research Operations for Secondary Use of Clinical Sites’ EMR
Sponsors’ pharmacovigilance and medical affairs teams frequently gather RWD directly from medical sites for chart reviews, registries, and other observational studies. These sources have also become more attractive sources for RWD to supplement new indication applications, particularly under […]
The Role of Integrated Scientific Advice for the Early Determination of RWE Requirements in HTA and Payer Assessments
Real-world evidence (RWE) is a ubiquitous conversation topic in discussions on the current health technology assessment (HTA) landscape for biotech and biopharma assets. By now it is widely known that RWE is an unavoidable part of drug development and should be given thorough consideration, ideally […]
Pragmatic Randomized Trials: Considerations for Design and Implementation
The 21st Century Cures Act (Cures Act),1 which became law in the United States December 13, 2016, has highlighted the need for robust real-world data to demonstrate effectiveness and safety of healthcare innovations that meet the requirements of regulators and payers alike. Included in the Act is an […]
Current Landscape: Value Assessment Frameworks
This report, “Current Landscape: Value Assessment Frameworks,” analyzed seven existing U.S. value assessment frameworks, comparing and contrasting the strengths and limitations associated with each framework. It examined the frameworks through the lens of six broad categories: development process, […]
The New Health Economy is Here. Do You Have the Right Knowledge Resources in Place?
The rapid pace of innovation, the rise of consumerism, an aging population, and movement toward price transparency are placing significant pressure on healthcare companies to stay agile and competitive. Understanding the forces affecting drug development, pricing, and prescribing is crucial to […]
