How Biotechs Can Cut The Negative Impact Of Protocol Amendments

Social distancing laws in response to the COVID-19 pandemic forced dramatic changes to procedures for the collection, monitoring, review and analysis of clinical data in trials. Regulators have responded with an appropriate degree of flexibility but some CROs initially struggled to manage the impact on clinical trials.

Protocol amendments are more common in clinical trials than you might think. A 2017 article by the Tufts Center for the Study of Drug Development (CSDD) found 59% of clinical trials have at least one protocol amendment (PA). Why should this matter? Protocol amendments have a major impact on CRF design, which typically lead to delays and system downtime for CRF updates, and ultimately increased costs for sponsors. It’s important also to highlight the frustration experienced at sites due to their inability to enter data during system downtime, which leads to backlogs in data entry.

Clearly, it is important to work with a CRO that is able to minimise the impact of protocol amendments on trial timelines.