DRAP recommends 3 clinical studies of 2 private medical institutions.
ISLAMABAD -- Clinical Study Committee of Drug Regulatory Authority of Pakistan (DRAP) Tuesday recommended three clinical studies of two private medical institutions.
In its meeting which was conducted under the Chairmanship of Dr Abdur Rashid has approved the clinical studies of Shifa International Hospital Islamabad and Agha Khan University Karachi.
According to details, Shifa International Hospital Islamabad was interested to conduct clinical trial on Colchicine for the prevention of preoperative a 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 safety 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 Shahdra 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...
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