1. Getz K, Stergiopoulos S, Short M, et al. The impact of protocol amendments on clinical trial performance and cost. Ther Innov Regul Sci. 2016;50(4):436–41.
2. Kaitin K, editor. Rising protocol complexity is hindering study performance, cost, and efficiency. Tufts CSDD Impact Report. 2018;20(4):1–4.
3. Kaitin K, editor. Rising protocol design complexity driving rapid growth in clinical trial data volume. Tufts CSDD Impact Report. 2021;23(1):1–4.
4. Getz K, Zuckerman R, Cropp A, Hindle A, Krauss R, Kaitin K. Measuring the incidence, causes, and repercussions of protocol amendments. Drug Inf J. 2011;45:265–75.
5. Getz K, Smith Z, Kravet M. Protocol design and performance benchmarks by phase and by oncology and rare disease subgroups. TIRS. 2023;57(1):49–56.