Impact of Protocol Amendments, Personnel Experience and Social Determinants of Health on Study Protocol Adherence in Clinical Trials with Combination Products
while larger numbers of participant were associated with more deviations, site preparedness and patient compliance can mitigate these risks, underscoring the need for robust quality management systems in clinical trials.
Authors
- Marina A. Malikova (ORCID: https://orcid.org/0000-0003-1370-187X)
- Artem Kaliaev (ORCID: https://orcid.org/0000-0002-8978-1178)
- Katherine N. Cilley
Institutions
- Boston Medical Center (US)
Publication Details
- Journal
- Therapeutic Innovation & Regulatory Science
- Published
- 2025-08-16
- DOI
- https://doi.org/10.1007/s43441-025-00859-y
- Primary Topic
- Statistical Methods in Clinical Trials
- Type
- article
- Field-Weighted Citation Impact
- 0.00