Clinical Research Protocol is the single most crucial document describing the study design, objectives, methodology, scientific background of the molecule, the rationale of the study, guidelines to be followed, statistical consideration, and safety precautions for ethical conduction of the study. Hence, peer review of the protocol plays a significant role in order to capture all the necessary information considering the risk involved with the investigational medicinal products.
We have reviewed the protocol of one anticoagulant drug, Rivaroxaban, on behalf of our client during the draft stage of the protocol. Based on the relevant literature (OGD recommendation, Public Assessment Report, and articles), we found that clotting parameters (e.g. PT, APTT) are being affected by Rivaroxaban. During protocol review, we observed that clotting tests (APTT and PT) were only mentioned on the day of screening.
Hence, considering the safety of subjects, we suggested performing clotting tests on the check-in day of each period and at the time of check-out of the last period. In addition, we have also strongly suggested performing a creatinine clearance (CrCl) test, as a low level of CrCl results in an increased plasma level of Rivaroxaban leads to an increase in bleeding risk, on the day of Period 01 check-in and on the end of the study.
A peer-review process is a filter to ensure all relevant information and required procedures are captured comprehensively, and also to avoid any methodological errors, gaps in knowledge, and other improvements through constructive feedback.
We at Zenovel have extensive experience in designing the study protocol based on the molecule profile, route of administration, therapeutic indications, and the risks involved with the molecule.
Design your complex trial with Zenovel.