Surabaya– Principal investigator of the Red and White Vaccine (VMP) Clinical Trial Dominicus Husada reported that recruitment of 4005 subjects of the VMP Phase 3 Clinical Trial has been completed. The second injection is currently underway on 1008 of the 4005 subjects and safety aspects are being evaluated.
Dominicus said the 4005 subjects were recruited from five clinical trial sites, namely from Dr. Soetomo Hospital, Airlangga University Hospital (RSUA), Saiful Anwar Hospital Malang, Dr. Soebandi Hospital and Jember Lung Hospital. This was conveyed in a meeting site monitoring visit by team clinical monitor Center for Health Effort Policy, BKPK which is ongoing hybrid, in Surabaya, Tuesday (09/08/2022).
On the same occasion, Brian Eka Rachman, the VMP clinical trial research team from Airlangga University Hospital reported on the progress of the clinical trial at the RSUA site, "of the 1752 subjects recruited, only 69 subjects were... non-eligible and 4 subjects dropped out, subject non-eligible "On average, due to high blood pressure, abnormal ECG and pregnancy," he said.
There were several obstacles in the implementation of the VMP phase 3 clinical trial, including subjects who were not honest in providing information about their history of comorbidities or diseases suffered at the time of recruitment, added Brian.
Prof. Dr. Ni Nyoman Tri Puspaningsih as the Deputy Chancellor for Research, Innovation and Community Development In his speech, he said, "The VMP clinical trial was an extraordinary experience, where the team from Dr. Soetomo Hospital as the person in charge of this clinical trial worked incredibly hard together with other multi-center hospital sites. Hopefully, the togetherness and good coordination can be seen in the results later." monitoring" he said.
Muhammad Karyana as Person in Charge (PIC) VMP Clinical Trial from Pusjak UK, BKPK explained that "BKPK as a sponsor according to Good Clinical Practice (GCP) is obliged and must be able to guarantee and facilitate all activities, especially for the VMP clinical trial, VMP is our shared ideal, everyone must support Indonesia to have its own vaccine, especially the Covid 19 vaccine. BKPK is part of the VMP team, so that VMP can be released immediately as our shared goal," said Karyana.
The series of Clinical Monitoring activities for the VMP Phase 3 Clinical Trial of the Unair-Biotis Platform were carried out by the Center for Health Effort Policy, BKPK from 1-19 August 2022 online and offline.
The activity begins with completing data entry and uploading. paper case report form (CRF) on the REDCap application carried out by the VMP Clinical Trial data entry team, the monitoring team from BKPK will carry out verification critical variable on the REDCap application.
Next, a visit was made to website research that aims to ensure that the entire research team complies with and carries out research based on applicable protocols and regulations, ensures that the safety and welfare of research subjects are protected and that the data collected is valid/authentic and can be accounted for.
Tim clinical monitoring verify documents trial master file as well as source documents such as CRF, e-Medical Record, and laboratory test results. "really appreciate the good work of the UK VMP team, because it is not easy to recruit 4005 subjects in a short time with a time limit that must be right," said Retna Clinical monitoring BKPK during a discussion with the VMP team.
At the end of the visit, the team clinical monitoring submit findings for follow-up with improvements by the VMP clinical trial team.
Author: Eni Yuwarni | Editor: Cicih Opitasari
