Getting a new oncology drug to patients involves navigating an obstacle course of costs, timelines, safety and effectiveness data, and regulations. Starting the clinical process with a molecule that has already been proven to kill cancer cells and be safe for patients will eliminate much of the risk. That is exactly what NanOlogy, a clinical-stage oncology company, is attempting to do.
Pharmaceutical reimbursement historically has largely been a process of first determining the efficacy and safety profile of a therapy and then deciding its ultimate coverage level based on its price. But now, payers are taking a cue from their European peers and beginning to do the sophisticated number-crunching and cost-effectiveness studies to take a more holistic approach to drug coverage.
Randomized clinical trials (RCTs) of prescription drugs and other medical products have been considered the gold standard of evidence to support decision making by clinicians and policymakers. However, it is increasingly recognized that most RCTs are unable to generate information about a product’s real-world effectiveness. Measures such as long-term outcomes, comparisons among multiple treatment options, and utilization are not well captured in trials. Furthermore, benefit-risk balance and value for money are best learned in cost-effectiveness or cost-benefit analyses.
Sorry, pharma executives. We have all been duped for years that the FPI milestone yields an increase in stock price and company value.
In the first annual Patient Adherence Influence Report, Adheris Health and inVentiv Health Consulting set out to understand the most influential factors driving patient adherence or non-adherence and to answer the question: Will the patient cross the finish line at the retail pharmacy, or will he or she walk away?
This white paper represents a compilation of industry best practices for designing, implementing and leveraging randomization and trial supply management (RTSM) software in clinical trials.
Read how utilizing electronic data capture systems ─ including eCOA ─ and training site raters, subjects and caregivers are important tools to ensure high quality data capture in rare disease research.
A discussion of the commonly encountered hurdles in studying rare diseases and how a cohesive and holistic approach can mitigate issues and help bring new treatments to patients.
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What clinical researchers should consider as they start to make the essential pivot toward electronic data capture.
Understanding the integration challenges and technical demands of implementing electronic data capture (EDC) solutions.
Understand how Metrics provide the foundation for business intelligence for clinical trials, measuring success or failure.
Read how new technological solutions are enabling humanistic patient reported outcomes (PROs) that enhance Real-World Evidence (RWE) and support better informed healthcare decisions.
Learn more about how you can control diabetes, and give patients the opportunity to take back their life and enjoy what makes them happy.