The 'Assessing the Evidence for Health Care Decision Makers' is an interactive questionnaire for users of evidence to assess health care research studies used in health technology assessments and/or drug formulary decisions. More information available here. (Source: Assessing the Evidence). […]
Could Ebola Vaccines Be Released Without Clinical Trials?
Health authorities are determined to get Ebola vaccines deployed and in use within months, dispensing with some of the usual testing, but raising unprecedented ethical and practical questions. The World Health Organization (WHO) has convened vaccine specialists, epidemiologists, pharmaceutical […]
How Does Crossover Affect Overall Survival Analysis In Randomized Controlled Trials
During oncology clinical trials, if a patient's disease progresses, they are often given the opportunity to cross over to active treatment. This alleviates ethical issues associated with placebo controls, but how does it effect the analysis of overall survival and cost-effectiveness? Read more here. […]
Is The Evidence-Based Movement A Dangerous Fraud?
How fragile is the relationship between scientific method and medicine? Should medicine even be considered a science? What about Evidence-Based Medicine (EBM) - is it serving patients or industry? Read this article for a close up view of Evidence-based Medicine, here. (Source: Prof Dr BM Hegde, […]
Video Explains Why Doctors Don’t Always Know Best!
The old saying, "Doctor Knows Best" is not necessarily the way it works. Although we like to think doctors have all the information they need to decide on which treatment is the best for a particular patient, unfortunately, this is not always the case. What information is really needed and why do […]
How Can The U.S. Congress Help Cures Get To Patients Faster?
The U.S. Energy & Commerce Committee is sponsoring the 21st Century Cures Initiative, a bi-partisan effort with the mission of identifying actions Congress can take to accelerate the pace of cures in America - from discovery through development to delivery - with the end goal of developing […]
Pharmaceutical & Medical Device Companies – What Can Continuum Clinical Do For You?
Suburban Chicago-Based Healthcare firms Blue Chip Patient Recruitment (BCPR) and J Trotter Research & Consulting (JTRC) have merged to form Continuum Clinical, uniquely positioned in the market to provide three distinct, yet interrelated services to pharmaceutical and medical device companies. […]
Increasing Drug Value With Pharmaceutical PRO Metrics
Cutting Edge Information recently examined how the life sciences industry has embraced patient-reported outcomes (PRO) and how they use pharmaceutical PRO metrics. Pharmaceutical PRO metrics offer both clinical teams and regulatory agencies a complete picture of a drug's effects and its' future […]
Oncology – Topping The Charts For Clinical Trial Compensation
With nearly all of the required medical procedures compensated at a specialist's hourly rate, it is no wonder that oncology is the top disease area for clinical trial compensation. A new study from Cutting Edge Information examined nine therapeutic areas: Arthritis, Cardiovascular, CNS and […]
Pharma Doctors Say: Publish All Clinical Trials!
A recent survey conducted by the Faculty of Pharmaceutical Medicine has said ALL clinical trials should be registered and published with a year or two. The majority of surveyed members also believed that such transparency would not harm pharma, but would result in a stronger science base and […]
Observational Studies: Getting Clear about Transparency
When publishing observational research, what information should journals make available to the medical community before a result can be considered sufficiently reliable to inform patient care or health policy? Read more here. (Source: PLOS, 8/26/14). […]
The Future of Cancer Immunotherapy: KOL Views Bring Opportunities Into Sharp Focus
The cancer immunotherapy market is evolving rapidly and attracting considerable media hype and clinical interest. There has been talk of late stage cancers being managed as chronic conditions, significant increases in life expectancy, even a cure; But what is the true state of cancer immunotherap? […]
Your Roadmap to Patient-Focused Trials.
Download the FDA Roadmap App Presented by PHT Corporation. Available on the Apple App Store and Android App on Google. […]
How Informed Should Informed Consent Be?
The FDA has recently issued an updated guidance document on obtaining informed consent for clinical trials. The majority of the document content appears to remain unchanged, specifying in greater detail how consent should be obtained. The one exception being a section urging that trial participants […]
How Can We Use RCT Data To Assess Heterogeneity Of Treatment Effecs? Let Me Count The Ways
Check out the following presentations, as part of W11: How Can We Use Randomized Trial Data to Assess Heterogeneity of Treatment Effects? Let Me Count The Ways - a workshop for the recent ISPOR 19th Annual International Meeting in Montreal. How Can We Use RCT DATA to Assess Heterogeneity of […]
Modelling Alchemy: The Impact of Unorthodox Trial Design on Health Technology Appraisal Strategy
Rachel Beckerman, PhD, Principal, Value Demonstration, CBPartners; Meghan Gallagher, Director, Global Health Economics and Outcomes Research, Oncology, Sanofi; Anthony Hatswell, MSc, Senior Health Economicst, BresMed; Marc Bardou, MD, PhD, Gastroenterologist, Centre Hospitalier Universitaire Le […]
Could Social Media Be The Key To Clinical Trial Recruitment?
Pharma's move towards patient centricity has initiated a wave of social media start-up activity, but what's in it for pharma? Take a look at how social media is being used to drive clinical trial recruitment - you may be surprised with the outcome. More here. (Source: Ulrich Neumann, eyeforpharma). […]
Is It Time to Retire the Randomized Controlled Trial?
ISPOR 19th Annual International Meeting - Montreal Second Plenary Session Read more here. […]
Can Evidence Synthesis Be Carried Out Using The Bootstrap?
On the surface, evidence synthesis and bootstrapping seem incompatible, but this recent report shows a simple and intuitive modification of the bootstrap can indeed accommodate parametric evidence synthesis. More here. (Source: Mohsen Sadatsafavi and Stirling Bryan, The Academic Health Economists' […]
Could Electronic Health Records Lower Cost Of Clinical Trials?
The existing clinical trial process can be lengthy and very costly, but researchers are taking a look at how electronic health records can change that. Read more here. (Source: Medical press, 7/11/14). […]
How Much Can Social Media Improve Oncology Clinical Development And Recruitment?
Patient recruitment remains one of the biggest challenges facing companies involved in oncology clinical development. If only there were some avenue through which companies could reach large communities of patients just perfect for their trials..Oh wait - There is! Read more here. (Source: Natalie […]
What Are The Advantages And Disadvantages Of Using Observational Data In Healthcare Decision Making?
In the second plenary session of the recent ISPOR 19th Annual International Meeting, the arguments of randomized clinical trials versus real world observational studies were debated. What are the Advantages and Disadvantages of Using Observational Data as the Basis of Decision Making in Health Care? […]
Investing In Clinical Research For The Public Good
The NIH collaboratory is a common-fund project in which we currently are funding five large-scale clinical trials that are leveraging modern information technologies and making it possible to conduct these trials at very low costs. The Patient-Centered Outcomes Research Institute (PCORI) has just […]
Does Health Economics Have A Role In The New Era Of Personalized Medicine?
Does Health Economics Have a Role in the New Era of Personalized Medicine? was one of the top three attended sessions at the recent ISPOR 19th Annual International Meeting. This slideshow walks you through personalized medicine, its key challenges, and its future needs. (Source: ISPOR, 2014). […]
What Do We Know About Treatment Satisfaction Assessment In Clinical Trials To Date?
Manufacturers and payers currently benefit from learning about whether the treatment is effective at managing symptoms and health related quality of life but learning about the overall potential benefit, quality, and value of a pharmaceutical intervention for the patient, may also be beneficial… […]
ISPOR Published Book On Reliability & Validity Of Data Sources
The ISPOR Patient Registry Special Interest Group developed this book, ISPOR Taxonomy of Patient Registries: Classification, Characteristics and Terms, to demystify the world of patient registries by providing a working definition and describing distinguishing characteristics of a patient registry. […]
Does Participation In Clinical Research Really Matter?
This Book, The Gift of Participation, takes a fresh look at why participation in clinical research really matters and offers a comprehensive guide for volunteers to navigate the clinical research process. To all of you volunteers, we offer our thanks and admiration. Available for purchase here. […]
BIG DATA – Where Are We And What Does The Future Hold?
Check out this First Plenary Session at ISPOR's 19th Annual International Meeting in Montreal with Moderater Marcus Wilson, PharmD, President of HealthCore presenting: The Use Of "Big Data" - Where Are We And What Does The Future Hold? Speakers include David R Holmes III, PhD; William H Crown, PhD; […]
Simulation Modeling – A Holistic Approach To Rare Diseases
Take a look at rare disease in the May newsletter from Clinical Trial & Consulting (CTI). Rare Diseases, as the name suggest affects a relatively small percentage of the population, however the cost of finding treatments is not any cheaper, so with fewer patients the actually cost of receiving […]
New Patient-Focused Clinical Trials App Available From PHT
The Roadmap App is just another example of PHT innovation in mobile technology for clinical research. The PHT LogPad System which collects compliant patient data using smartphones has been a finalist for the Clinical Informatics News Best Practices Award and the SCDM Data Driven Innovation Award and […]
