Prevent Clinical Study Protocol Amendments

Prevent clinical study protocol amendments

Protocols have become more demanding and complex and as a result more amendments arise. In fact, ‘the majority of clinical trial protocols are amended but one third of those changes are avoidable’ according to a study conducted by Tufts CSDD [1]. Amongst the causes of amendments that could have been anticipated and avoided are undetected design flaws, inconsistencies, or errors in the protocol. This finding strongly suggests the need for better protocol planning and design. Therefore, we have focused on strategies and techniques to prevent clinical study protocol amendments.

Another factor contributing to protocol complexity is a rise in non-core procedures. This means there is more data to collect and process. More importantly, it puts an unnecessary burden on sites and patients and leads to patients being less likely to participate.

We, at intilaris, understand patient challenges and clinical operation procedures and our Structured Protocol Framework tackles the issues of complexity by:

1. Structuring the Protocol to make changes transparent so that the impact of changes becomes visible and quantifiable. Costly changes can then be avoided.

2. Identifying and highlighting the impact of patient procedures thus eliminating the cost of unnecessary procedures and associated data collection. Consequently, fewer procedures in the protocol lead to more successful patient recruitment and retention.

Our structured study design model has been implemented together with a major pharma organization and is considered by them as ‘culture changing’.

Having the clinical protocol in the structured format, enables the clinical teams to have a significantly better overview of the protocol design elements, patient population characteristics and the protocol complexity. Such transparency makes the protocol development collaboration much more effective enables us to prevent clinical study protocol amendments.

Please reach out to us for an independent and expert consultation on this topic.


[1] Getz. K.A. (2011) Protocol Amendments: a Costly Solution [Online], Available:… [18 Feb 2016]