The concept of a pragmatic clinical trial was developed to create a trial that can practically answer questions like, “Is the healthcare we are delivering really safe and effective?” and, “Which of the healthcare options should we use in practice to provide the best care to the patient?”. While the pragmatic clinical trial design has been around for a long time, we are seeing tremendous growth in the prevalence of these trials designed to help us understand the gap between “efficacy” and “effectiveness.”
Read this white paper to learn what pragmatic clinical trials are, and how they are designed and intended to answer important questions in health care.
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Something Has to Give: The Current Unsustainable Approach to Safety Reporting Puts Trials and Patients at Risk
Something Has to Give: The Current Unsustainable Approach to Safety Reporting Puts Trials and Patients at Risk
Quality First: Using Data to Inform Site Selection in CNS
WCG MedAvante-ProPhase espouses a rather simple philosophy: minimize variability, generate cleaner data.
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How can a site move up the selection list and participate in these trials? It’s as simple as one word: metrics.
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Learn what high-performing research sites have in common, and what makes sponsors return to them again and again.
Not Like Everyone Else: Unique Challenges for Small & Emerging Biopharma Companies
Small and emerging biopharmas are conducting almost 50% of clinical trials in the U.S., often with lean teams, resources and infrastructure. Learn how to reduce the pressure on teams and timelines.
Question: What are the requirements for submitting protocol deviations?
Some deviations from the IRB approved protocol are planned while others are unintentional or unplanned. The FDA and HHS (45 CFR §46.103(b)(4) and 21 CFR §56.108(a)(4)), position is that...
Question: Does the IRB need to review news stories?
The local newspaper is planning to run a story on a new clinical trial that will highlight the development of an exciting new drug and the work done by our principal investigator...
Question: When can research participants be paid?
As a sponsor, what do the regulations say about paying research subjects? What are acceptable practices for compensating subjects for participating in a clinical trial?
13:58The Role of Expert Committees: An interview with Dr. Seltzer
What’s the role of expert committees today? What’s happening on the regulatory side? Dr. Seltzer, Chief Scientific Officer of WCG Clinical, shared his insights on expert committees during a recent...
32:32Eliminating the Headache of Global Safety Reporting to Investigators and Ethics Committees
52:22Recruiting Patients & Time Management: Top Tips for Dealing with the Most Critical Resource in Research
Learn how to engage sites more effectively with the appropriate recruitment resources, use dedicated staff to manage recruitment efforts, and eliminate bottlenecks and expedite recruitment timelines.
How Roche Optimized its Global Safety Reporting Process for Clinical Trials
