Can Your Clinical Trial Design Handle Mid-Study Changes?

By Walker Bradham, Product Management Lead for Clinical Development Solutions, Merative

As clinical research advances, the pharmaceutical and biotech industries increasingly focus on daunting conditions previously thought to be uncurable, including certain cancers and rare diseases. Promising new drugs offer tailor-made solutions for patients, and the clinical trials that bring them to market must also be customized to meet participants’ needs. However, these innovations result in frequent mid-study changes.

According to the Tufts Center for the Study of Drug Development¹, from 2018-2020, 78% of Phase 2 and 69% of Phase 3 clinical trials required at least one substantial mid-study protocol amendment, averaging 2.7 and 3.3 amendments respectively. Before 2020, one Phase 3 mid-study change cost an average of $535,000 in unbudgeted expenses, resulting in a three-month delay. Given recent inflation and the rising costs of trials, protocol amendments have become even more expensive. Therefore, with rising stakes and growing complexity, today’s clinical trials are intricate, data-heavy, and subject to protocol amendments. Pharmaceutical and biotech companies need streamlined solutions to effectively mitigate mid-study changes.

[1] Impact Reports — Tufts CSDD