Using data-informed insights derived by effectively implemented datasets, artificial intelligence/machine learning capabilities, and technology sponsors can realise increased predictability in their study planning from protocol design through enrolment strategy.
Critical analysis in protocol design
Nearly eight out of 10 (78%) phase II protocols and 69% of phase III protocols have at least one substantial protocol amendment, and they average 2.7 and 3.3 per protocol, respectively. It’s estimated that pharmaceutical and biotechnology companies spend between $7 billion and $8 billion ($US) annually to implement protocol amendments.* Previous research showed that 23% of these amendments were considered “completely avoidable” because they were due to protocol design flaws, inconsistencies, or errors.† Protocol design factors leading to operational challenges include design consistency, patient burden, site burden, study complexity, and eligibility criteria, including diversity and inclusion requirements. These potential study risks can lead to costly deviations and amendments, enrolment difficulties, and reduced patient compliance.
