DRAP committee approves three clinical studies
ISLAMABAD: Clinical Study Committee of Drug Regulatory Authority of Pakistan (DRAP) has approved three clinical studies.
The studies were approved in a meeting conducted under the Chairmanship of Dr Abdur Rashid. The meeting members were informed that Shifa international hospital Islamabad was interested to conduct clinical trial on Colchicine for prevention of preoperative trial fibrillation in patients undergoing thoracic surgery.
This is a Phase III, multi-Centre, blinded, randomised controlled trial with a sample size of 2,800 patients.
Second study was a phase III , matrix design, partially double blind, randomised study of the efficacy and of 50mg Ritonavir submitted by Agha Khan University Karachi.
While third trial approved was the use of granulocyte colony stimulating factor for biliary atresia as a part of a phase II in Paediatric surgery, Agha Khan University Hospital Karachi.
Fatima Jinnah Medical University Lahore included Sir Ganga Ram hospital 908-bed Shahdara teaching hospital 263-bed hospital, and Mozang teaching hospital, 30 bed hospital is deferred due to non approval from IRB and National Bioethics Committee.
Crash -19 trial is a multinational, open-label, factorial, randomised phase III, for six tertiary care hospitals is referred to three experts Brig. Najmi, Dr Mushtaq and Dr Faiza PHRC for their technical opinion.
Tahir Shamsi trial has been deferred due to non submission of revised protocol to National Bioethics Committee.
A panel had been constituted for inspection of University of Lahore to observe the facility as clinical trial site.
Similarly, Isolation, purification and enrichment of immunoglobulin G and immunoglobulin M from human plasma of recovered individuals from Covid-19 submitted by University of Lahore was deferred due to incomplete application.
Application for protect clinical trial of Fatima Jinnah medical University Lahore is deferred to meet required documents. Children hospital Karachi of convalescent plasma was deferred due to non approval from IRB and NBC.
Clinical Study Committee was briefed about Kits of NUST and decided to get first approval from NBC.
Secretary of subcommittee on National Data Safety Monitoring briefed that 261 patients’ data has been evaluated by Prof Zeeshan Danish and no mortality and severe adverse occurred in three hospitals of Punjab Government under the Dr Ammar Sarwar.
Dr Abdur Rashid said research work would be appreciated in Covid -19 pandemic. - APP