It is critical to maintain patients on drug supplies during clinical trials, both for the success of the study and for the health of the patient. In this second part of this series on ensuring adequate drug supply, we will look at some specific strategies for successfully managing the clinical supply inventory.
Data management functions are managing a much higher volume and diversity of data in response to the increasing scope and demands of global drug development programs. Real-world data and evidence, electronic clinical outcome assessments, data from smartphones and mobile devices, social media community data, and electronic health/medical records are examples of the variety of new data sources now captured during a clinical trial. The volume and diversity of data presents integration, compatibility, and interoperability challenges that must be optimized to improve drug development performance and efficiency.
The vast majority of rare diseases have no approved treatments available, despite the fact that research related to these diseases has expanded significantly in the past 20 years. A key reason may be the many unique challenges researchers face when developing drugs to treat rare diseases, including difficulties designing and executing effective and appropriate clinical trials.
The FDA has released a Draft Guidance titled Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 – Questions and Answers. Certainly, the development of this draft guidance was driven by the repetitious questions the FDA has received from industry stakeholders as well as the extensive technology advancements.
Based on Amazon's approach to building its business, it is logical to conclude that the online retailer would be an amazing CRO. Amazon’s competitive strategy is to aggressively discount prices to win market share. Plus, its customer obsession and disruptive innovation are second to none. Let’s imagine what an Amazon-run CRO would look like.
Recently, a pharmaceutical executive raised an interesting question in the media. To paraphrase, he asked, “What should a corporate entity do when it has new information that is material to its financial situation and that new information is ‘under embargo’ until it is either published in a journal or presented at a scientific meeting?”
Integrating clinical trials within registries offers several opportunities: avoiding duplicative data collection, identifying and recruiting patients more efficiently, and accelerating decision making, to name a few. These efficiencies have the potential to reduce clinical trial costs — especially when a registry is used to conduct multiple clinical trials.
The clinical trial environment in India has seen a downward trend since 2013, when the government approached the Supreme Court regarding the death of 2,644 volunteers during clinical trials over seven years.
You recently attended a clinical research conference, webinar, or sales pitch on risk based monitoring (RBM). Or your clinical team is putting together a strategy for a new trial and wants to implement RBM. Everyone you talk to is raving about efficiencies, cost savings, and how it’s the future of clinical research. Or maybe people are telling you how hard it is to implement RBM.
While the ability to ship drugs to sites on the surface appears to be simple, failures to meet demand occur, in my view, far too often.
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