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ACRP Article: The Importance of Planned Protocol Authoring

April 25, 2019

Legal Research and Writing

Below is an excerpt from our recent article published in the April 2019 issue of ACRP’s Clinical Researcher (Volume 33, Issue 4). The April issue delivers insights on “The Nuts and Bolts of Clinical Research” with a focus on many such areas of clinical research that few people involved in the process think about until it’s too late.


Even though the importance of protocol authoring is widely acknowledged, many challenges that show up in clinical research projects can be traced back to issues with the protocol document. Common examples of such issues include lack of clarity, inconsistency, and missing information. These issues are generally addressable in the protocol authoring process, and would not only prevent costly errors and delays, but also ensure a safe and effective process with fewer protocol violations. When such omissions or errors are discovered in the protocol, amendments are introduced leading to increased administrative burdens, expectations for retraining, and manual rework at levels which are detrimental to the overall study process.

study conducted in 2010 by the Tufts Center for the Study of Drug Development examined protocol amendment data from more than 3,400 protocols from multiple phases and therapeutic areas. Nearly all protocols had at least one amendment, and more than a third of the amendments were categorized as being partially or completely avoidable. This excludes amendments that were made as a result of new safety information, regulatory requests, or changes in standard of care, but rather were due to flaws in the design and/or document.

Correlating this information with other data provided by the survey participants, it was observed that the direct cost resulting from a single protocol amendment was nearly $500,000, along with the addition of 61 days to the overall study duration. It is important to note that such unplanned expenses and delays come in addition to other challenges not as easily quantified (e.g., extra effort required by study teams, resubmissions, and other problems for the participating sites). Overall, the study estimated that in 2014 there was a cost of approximately $2 billion that could be attributed to avoidable protocol amendments for all active global U.S. Food and Drug Administration–regulated trials in that single year.

Read the full article here

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