Laying the Groundwork to Measure the Impact of Decentralized Clinical Trials (DCTs)
The Tufts CSDD Roundtable took place in November, and on behalf of Veristat, I was honored to participate in this invite-only program. It is part of...
3 min read
The Food and Drug Administration (FDA) has started encouraging the use of adaptive designs for clinical studies. In essence, adaptive designs allow prospectively planned modifications to a clinical trial based on interim data, provided scientific validity (the ability to draw sound inferences) and data integrity (credibility and reproducibility) are preserved.
After issuing draft guidance in 2010, the agency’s Center for Devices and Radiological Health and Center for Biologics Evaluation and Research released final guidance on the topic in 2016.
Their intent was to clarify how best to plan and carry out adaptive design for clinical trials (particularly in medical device development) and to boost the approach’s uptake among companies. But despite the FDA’s embrace of the design method, how do you know whether adaptive designs would be beneficial, practical or appropriate to implement?
As with most methodologies, pros and cons vary based on the type of trial needed, the patient population, resources and appropriate data management strategies, and many other factors. However, there are some key issues that bear consideration to help you figure out if the design merits a serious look for your upcoming studies.
Although the pros of adaptive design sound very promising, the approach is not without its challenges.
Here are some additional details to consider to help you decide whether this creative approach to clinical trials interests you:
With proper planning, collaboration with the FDA, data management, and simulation work, adaptive design can offer a unique way to streamline your clinical trial process experience. As the field of adaptive design continues to develop, Veristat will continue to offer expert solutions and services targeted toward optimizing the planning and implementation of clinical trials.
Read about the considerations required for adaptive design clinical trials based on the FDA’s recent guidance:
The Tufts CSDD Roundtable took place in November, and on behalf of Veristat, I was honored to participate in this invite-only program. It is part of...
1 min read
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