FDA Circular 2012-007 released last June 7, 2012.
“Clinical trials are conducted to evaluate the effectiveness and safety of new medications or medical devices. This is the bridge we need to take before introducing them for public use. Clinical trials should be carefully designed to ensure that no human is harmed or abused during the study period,” explained Dr. Suzette H. Lazo, Former Director of the FDA during the 6th Philippine National Health Research System Week celebration.
To ensure better protection of Filipino patients who participate in clinical research studies and safeguard the quality of generated research results, the Food and Drugs Administration (FDA) released its Circular 2012-007 which governs the conduct of clinical trials in the Philippines for compliance of the sponsor companies, Clinical Research Organizations (CROs), and Ethics Review Boards/Committees (ERBs/ERCs).
With the issuance of the circular, the role of ERBs is recognized and further strengthened as approval of clinical research studies will depend on their recommendations to the FDA. All clinical trial applications are subjected for ethical and technical evaluation. “To guarantee that ERBs comply with the international and national standards in performing their function, only ERBs registered, audited and accredited by the Philippine Health Research Ethics Board (PHREB) are authorized to conduct the review and make recommendations,” stressed Dr. Lazo.
As of September 2012, PHREB has accredited two ERCs namely, the Philippine Heart Center ERC and the University of the Philippines Manila – Research Ethics Board. Other PHREB-recommended ERCs are as follows: De La Salle University-Health Sciences Institute, St. Luke’s Medical Center for Clinical Trials, Research Institute for Tropical Medicine (RITM), and University of Sto. Tomas (UST).
The recommendation of ERCs is based on PHREB’s prior knowledge of how the ERCs conduct ethics review, and the board’s familiarity with their procedures.
The coverage of the circular includes Phases I, II, III, and IV clinical trials of investigational medicinal products described as any substance or combination of substances reported for its beneficial properties and may be administered to humans to treat and prevent diseases or used to make medical diagnosis.
To protect the public from biased reporting and publication, the Circular requires all clinical trials to be posted in the Philippine Health Research Registry (PHRR). “It is now mandatory to include all clinical trials in the Philippine Health Research Registry which is already live, within 30 days after approving the clinical trial application. The purpose of this is, of course, to improve the level of transparency, to control publication bias and to have an equal opportunity for those who would like to participate in the study,” said Dr. Lazo.
- Written by Administrator
- Created: 26 November 2012