At the core of revolutionizing post-approval research is understanding the fundamental differences in conducting research in pre-market randomized controlled trials (RCT) versus post-approval research.
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Post-approval research has a unique set of challenges, such as massive scope, and lengthy time horizons.
September 21, 2016 | by Lori Jones, Marketing Manager, Bioclinica
Investments in post-approval research are rising steadily year on year. Chances are, post-approval research represents a substantial part of a pharmaceutical, biotech, or medical device organization’s annual budget. But how much of that money is being wasted by conducting post-approval studies in an inappropriate and inefficient manner? Bioclinica’s free webinar Conducting Post-Approval Research Requires A Unique Mindset And Specialized Infrastructure. Do You Have What It Takes? shows how to reduce your post-approval research spend while simultaneously optimizing your study outcomes.
At the core of revolutionizing post-approval research is understanding the fundamental differences in conducting research in pre-market randomized controlled trials (RCT) versus post-approval research. For example:
Post-approval research is performed to satisfy a wide variety of business needs – it is not simply about whether drugs are safe and effective (the primary goals of Phase I, II, and III clinical trials).
Post-approval research has a unique set of challenges, such as massive scope, research-naïve physicians, and lengthy time horizons.
Post-approval research is not subject to the same regulatory requirements demanded in pre-market RCTs.
If the differences between pre-market RCTs and post-approval studies are not appreciated, then post-approval research becomes burdened by unnecessary rigor, inappropriate design, and inefficient execution. This results in inflated costs and increased resource burn. Studies can quickly become cost-prohibitive.
In contrast, treating post-approval research for what it is – not as a modified Phase I, II, or III trial – streamlines the operational processes involved, reduces costs, and enhances outcomes. For example, a successful post-approval study will utilize:
A patient-centric methodology for the design and implementation of the study
SOPs that are specifically-designed to meet the objectives of the study
Smart technology to improve the flow of communication and contain study costs
Centralized remote monitoring to support sites and ensure regulatory standards are met
A flexible, scalable, customizable technological infrastructure geared for post-approval research
With the pressing need to obtain real-world data, assess product safety profiles, and support the full span of a product’s lifecycle, the ability to conduct efficient, cost-effective post-approval studies is more important than ever.
View the webinar now to discover what it takes to conduct successful post-approval studies in today’s complex pharmaceutical environment.
For more information on Bioclinica’s post-approval research services, click here.
This blog post was originally published at: Post-Approval Research: Do You Have What It Takes?
How do you manage the challenges of post-approval research? Share your thoughts in the comments section below!
Keywords: Post-Approval Research, Randomized Controlled Trials, Real-World Data
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